Data Source Data kamagra reviews on all residents of Israel who had been fully vaccinated before June 1, 2021, and who had Full Report not been infected before the study period were extracted from the Israeli Ministry of Health database on September 2, 2021. We defined fully vaccinated persons as those for whom 7 days or more had passed since receipt of the second dose of the BNT162b2 treatment. We used the Ministry of Health kamagra reviews official database that contains all information regarding erectile dysfunction treatment (see Supplementary Methods 1 in the Supplementary Appendix, available with the full text of this article at NEJM.org). We extracted from the database information on all documented erectile dysfunction s (i.e., positive result on PCR assay) and on the severity of the disease after .
We focused on s that had been kamagra reviews documented in the period from July 11 through 31, 2021 (study period), removing from the data all confirmed cases that had been documented before that period. The start date was selected as a time when the kamagra had already spread throughout the entire country and across population sectors. The end date was just after Israel had initiated a campaign regarding the use of a booster treatment (third dose). The study period happened to coincide with the school summer kamagra reviews vacation.
We omitted from all the analyses children and adolescents younger than 16 years of age (most of whom were unvaccinated or had been recently vaccinated). Only persons 40 years of age or older kamagra reviews were included in the analysis of severe disease because severe disease was rare in the younger population. Severe disease was defined as a resting respiratory rate of more than 30 breaths per minute, oxygen saturation of less than 94% while the person was breathing ambient air, or a ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen of less than 300.14 Persons who died from erectile dysfunction treatment during the follow-up period were included in the study and categorized as having had severe disease. During the study period, approximately 10% of the detected s were in residents of Israel returning from abroad.
Most residents who traveled abroad had kamagra reviews been vaccinated and were exposed to different populations, so their risk of differed from that in the rest of the study population. We therefore removed from the analysis all residents who had returned from abroad in July. Vaccination Schedule The official vaccination regimen in Israel involved the kamagra reviews administration of the second dose 3 weeks after the first dose. All residents 60 years of age or older were eligible for vaccination starting on December 20, 2020, thus becoming fully vaccinated starting in mid-January 2021.
At that time, younger persons were eligible for vaccination only if they belonged to designated groups (e.g., health care workers and severely immunocompromised adults). The eligibility age was reduced to 55 years on January 12, 2021, and kamagra reviews to 40 years on January 19, 2021. On February 4, 2021, all persons 16 years of age or older became eligible for vaccination. Thus, if they did not kamagra reviews belong to a designated group, persons 40 to 59 years of age received the second dose starting in mid-February, and those 16 to 39 years of age received the second dose starting in the beginning of March.
On the basis of these dates, we defined our periods of interest in half months starting from January 16. Vaccination periods for individual persons were determined according to the time that they had become fully vaccinated (i.e., 1 week after receipt of the second dose). All the analyses were stratified according kamagra reviews to vaccination period and to age group (16 to 39 years, 40 to 59 years, and â¥60 years). Statistical Analysis The association between the rate of confirmed s and the period of vaccination provides a measure of waning immunity.
Without waning kamagra reviews of immunity, one would expect to see no differences in rates among persons vaccinated at different times. To examine the effect of waning immunity during the period when the delta variant was predominant, we compared the rate of confirmed s (per 1000 persons) during the study period (July 11 to 31, 2021) among persons who became fully vaccinated during various periods. The 95% confidence intervals for the rates were calculated by multiplying the standard confidence intervals for proportions by 1000. A similar analysis was performed to compare the association between the rate of severe erectile dysfunction treatment and the vaccination kamagra reviews period, but for this outcome we used periods of entire months because there were fewer cases of severe disease.
To account for possible confounders, we fitted Poisson regressions. The outcome variable was the number kamagra reviews of documented erectile dysfunction s or cases of severe erectile dysfunction treatment during the study period. The period of vaccination, which was defined as 7 days after receipt of the second dose of the erectile dysfunction treatment, was the primary exposure of interest. The models compared the rates per 1000 persons between different vaccination periods, in which the reference period for each age group was set according to the time at which all persons in that group first became eligible for vaccination.
A differential effect of the vaccination period for each age group was allowed by the inclusion of an interaction term between age and vaccination kamagra reviews period. Additional potential confounders were added as covariates, as described below, and the natural logarithm of the number of persons was added as an offset. For each vaccination period and age group, an adjusted rate was calculated as the expected number of weekly events per 100,000 persons if all the persons in that age kamagra reviews group had been vaccinated in that period. All the analyses were performed with the use of the glm function in the R statistical software package.17 In addition to age and sex, the regression analysis included as covariates the following confounders.
First, because the event rates were rising rapidly during the study period (Figure 1), we included the week in which the event was recorded. Second, although PCR testing is free in Israel for all residents, compliance with kamagra reviews PCR-testing recommendations is variable and is a possible source of detection bias. To partially account for this, we stratified persons according to the number of PCR tests that had been performed during the period of March 1 to November 31, 2020, which was before the initiation of the vaccination campaign. We defined three levels kamagra reviews of use.
Zero, one, and two or more PCR tests. Finally, the three major population groups in Israel (general Jewish, Arab, and ua-Orthodox Jewish) have varying risk factors for . The proportion of vaccinated persons, as well as the level of exposure to the kamagra, differed among these groups.18 Although we restricted the study kamagra reviews to dates when the kamagra was found throughout the country, we included population sector as a covariate to control for any residual confounding effect. We conducted several secondary analyses to test the robustness of the results, including calculation of the rate of confirmed in a finer, 10-year age grouping and an analysis restricted to the general Jewish population (in which the delta outbreak began), which comprises the majority of persons in Israel.
In addition, a model including a measure of socioeconomic status as a covariate was fitted to the data, because this was an important risk factor in a previous study.18 Since socioeconomic status was unknown for 5% of the persons in our study and the missingness of the data seemed to be informative, and also owing to concern regarding nondifferential misclassification (persons with kamagra reviews unknown socioeconomic status may have had different rates of vaccination, , and severe disease), we did not include socioeconomic status in the main analysis. Finally, we compared the association between the number of PCR tests that had been conducted before the vaccination campaign (i.e., before December 2020) with the number that were conducted during the study period in order to evaluate the possible magnitude of detection bias in our analysis. A good correlation between past behavior regarding PCR testing and behavior during the study period would provide reassurance that the inclusion of past behavior as a covariate in the model would control, at least in part, for detection bias..
Data Source Data on all residents of Israel who had been fully kamagra online in canada vaccinated before June 1, 2021, and who had not been infected before the study period were extracted from the Israeli Ministry of Health database on September 2, 2021. We defined fully vaccinated persons as those for whom 7 days or more had passed since receipt of the second dose of the BNT162b2 treatment. We used kamagra online in canada the Ministry of Health official database that contains all information regarding erectile dysfunction treatment (see Supplementary Methods 1 in the Supplementary Appendix, available with the full text of this article at NEJM.org). We extracted from the database information on all documented erectile dysfunction s (i.e., positive result on PCR assay) and on the severity of the disease after . We focused on s that had been documented in the period from July 11 through 31, 2021 (study period), removing from kamagra online in canada the data all confirmed cases that had been documented before that period.
The start date was selected as a time when the kamagra had already spread throughout the entire country and across population sectors. The end date was just after Israel had initiated a campaign regarding the use of a booster treatment (third dose). The study period kamagra online in canada happened to coincide with the school summer vacation. We omitted from all the analyses children and adolescents younger than 16 years of age (most of whom were unvaccinated or had been recently vaccinated). Only persons 40 years of age or older were included in the analysis of severe disease kamagra online in canada because severe disease was rare in the younger population.
Severe disease was defined as a resting respiratory rate of more than 30 breaths per minute, oxygen saturation of less than 94% while the person was breathing ambient air, or a ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen of less than 300.14 Persons who died from erectile dysfunction treatment during the follow-up period were included in the study and categorized as having had severe disease. During the study period, approximately 10% of the detected s were in residents of Israel returning from abroad. Most residents who traveled abroad had been vaccinated and were exposed to different populations, so their risk of kamagra online in canada differed from that in the rest of the study population. We therefore removed from the analysis all residents who had returned from abroad in July. Vaccination Schedule The official vaccination regimen in Israel involved the administration of the second dose kamagra online in canada 3 weeks after the first dose.
All residents 60 years of age or older were eligible for vaccination starting on December 20, 2020, thus becoming fully vaccinated starting in mid-January 2021. At that time, younger persons were eligible for vaccination only if they belonged to designated groups (e.g., health care workers and severely immunocompromised adults). The eligibility age was reduced to 55 years on January 12, 2021, and to 40 years on January kamagra online in canada 19, 2021. On February 4, 2021, all persons 16 years of age or older became eligible for vaccination. Thus, if they did not belong to a designated group, persons 40 to 59 years of age received the second dose starting in mid-February, and those 16 to 39 years of age received the second dose starting kamagra online in canada in the beginning of March.
On the basis of these dates, we defined our periods of interest in half months starting from January 16. Vaccination periods for individual persons were determined according to the time that they had become fully vaccinated (i.e., 1 week after receipt of the second dose). All the analyses were stratified according to vaccination period kamagra online in canada and to age group (16 to 39 years, 40 to 59 years, and â¥60 years). Statistical Analysis The association between the rate of confirmed s and the period of vaccination provides a measure of waning immunity. Without waning of immunity, one would kamagra online in canada expect to see no differences in rates among persons vaccinated at different times.
To examine the effect of waning immunity during the period when the delta variant was predominant, we compared the rate of confirmed s (per 1000 persons) during the study period (July 11 to 31, 2021) among persons who became fully vaccinated during various periods. The 95% confidence intervals for the rates were calculated by multiplying the standard confidence intervals for proportions by 1000. A similar analysis was performed to compare the association between the rate of severe erectile dysfunction treatment and the vaccination period, but for this outcome we used periods of kamagra online in canada entire months because there were fewer cases of severe disease. To account for possible confounders, we fitted Poisson regressions. The outcome variable was the number kamagra online in canada of documented erectile dysfunction s or cases of severe erectile dysfunction treatment during the study period.
The period of vaccination, which was defined as 7 days after receipt of the second dose of the erectile dysfunction treatment, was the primary exposure of interest. The models compared the rates per 1000 persons between different vaccination periods, in which the reference period for each age group was set according to the time at which all persons in that group first became eligible for vaccination. A differential effect of the vaccination period for each age group was allowed by the inclusion of an interaction term between age and kamagra online in canada vaccination period. Additional potential confounders were added as covariates, as described below, and the natural logarithm of the number of persons was added as an offset. For each kamagra online in canada vaccination period and age group, an adjusted rate was calculated as the expected number of weekly events per 100,000 persons if all the persons in that age group had been vaccinated in that period.
All the analyses were performed with the use of the glm function in the R statistical software package.17 In addition to age and sex, the regression analysis included as covariates the following confounders. First, because the event rates were rising rapidly during the study period (Figure 1), we included the week in which the event was recorded. Second, although PCR testing is free in Israel for all residents, compliance with PCR-testing recommendations is variable and is a possible kamagra online in canada source of detection bias. To partially account for this, we stratified persons according to the number of PCR tests that had been performed during the period of March 1 to November 31, 2020, which was before the initiation of the vaccination campaign. We defined three levels kamagra online in canada of use.
Zero, one, and two or more PCR tests. Finally, the three major population groups in Israel (general Jewish, Arab, and ua-Orthodox Jewish) have varying risk factors for . The proportion of vaccinated persons, as well as the level of exposure to the kamagra, differed among these groups.18 Although we restricted the study to dates when kamagra online in canada the kamagra was found throughout the country, we included population sector as a covariate to control for any residual confounding effect. We conducted several secondary analyses to test the robustness of the results, including calculation of the rate of confirmed in a finer, 10-year age grouping and an analysis restricted to the general Jewish population (in which the delta outbreak began), which comprises the majority of persons in Israel. In addition, a model including a measure of socioeconomic status as a covariate was fitted to the data, because this was an important risk factor in a previous study.18 Since socioeconomic status was unknown for 5% of the kamagra online in canada persons in our study and the missingness of the data seemed to be informative, and also owing to concern regarding nondifferential misclassification (persons with unknown socioeconomic status may have had different rates of vaccination, , and severe disease), we did not include socioeconomic status in the main analysis.
Finally, we compared the association between the number of PCR tests that had been conducted before the vaccination campaign (i.e., before December 2020) with the number that were conducted during the study period in order to evaluate the possible magnitude of detection bias in our analysis. A good correlation between past behavior regarding PCR testing and behavior during the study period would provide reassurance that the inclusion of past behavior as a covariate in the model would control, at least in part, for detection bias..
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If you notice any changes in your vision while taking this drug, call your doctor or health care professional as soon as possible. Call your health care provider right away if you have any change in vision. Contact you doctor or health care professional right away if the erection lasts longer than 4 hours or if it becomes painful. This may be a sign of a serious problem and must be treated right away to prevent permanent damage. If you experience symptoms of nausea, dizziness, chest pain or arm pain upon initiation of sexual activity after taking Kamagra, you should refrain from further activity and call your doctor or health care professional as soon as possible. Using Kamagra does not protect you or your partner against HIV (the kamagra that causes AIDS) or other sexually transmitted diseases.
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The Household Pulse Survey was designed to cheap kamagra pills meet a Cialis online canada need for timely information associated with household experiences during the erectile dysfunction treatment kamagra. The Department is committed to ensuring that the data collected by the Household Pulse Survey continue to meet information needs as they may evolve over the course of the kamagra. This notice serves to inform of the Department's intent to request clearance from OMB to make some revisions to the Household Pulse Survey questionnaire. To ensure that the data collected by the Household Pulse Survey continue to meet information needs as they evolve over the course of the kamagra, the Census Bureau submits this Request for Revision cheap kamagra pills to an Existing Collection for a revised Phase 3.3 questionnaire. Specifically, Phase 3.3 includes modifications to questions relating to vaccinations that expand response options for the number of doses and brand of erectile dysfunction treatment received.
Three items asked in prior phases that have been reinstated with regard to unemployment insurance benefits, with a modified reference period. And a question that was cheap kamagra pills reinstated relating to use of public transit and ridesharing. It is the Department's intention to commence data collection using the revised instrument on or about October 27, 2021. The Department invites the general public and other Federal agencies to comment on proposed, and continuing information collections, which helps us assess the impact of our information collection requirements and minimize the public's reporting burden. Public comments were cheap kamagra pills previously sought on the Household Pulse Survey via the Federal Register on May 19, 2020, June 3, 2020, February 1, 2021, April 13, 2021, and again on June 24, 2021.
This notice allows for an additional 30 days for public comments on the proposed revisions. Agency. U.S. Census Bureau, Department of Commerce. Title.
Household Pulse Survey. OMB Control Number. 0607-1013. Form Number(s). None.
Type of Request. Request for a Revision of a Currently Approved Collection. Number of Respondents. 3,150,000. Average Hours per Response.
20 minutes. Burden Hours. 1,039,500. Needs and Uses. Data produced by the Household Pulse Survey are designed to inform on a range of topics related to households' experiences during the erectile dysfunction treatment kamagra.
Topics to date have included employment, facility to telework, travel patterns, income loss, spending patterns, food and housing security, access to benefits, mental health and access to care, intent to receive the erectile dysfunction treatment, and educational disruption (K-12 and post-secondary). The requested revision, if approved by OMB, will add previously approved items to the Phase 3.3 questionnaire. The overall burden change to the public will be insignificant. The Household Pulse Survey was initially launched in April, 2020 as an experimental project (see https://www.census.gov/âdata/âexperimental-data-products.html) under emergency clearance from the Office of Management and Budget (OMB) initially granted April 19, 2020. Regular clearance was subsequently sought and approved by OMB on October 30, 2020 (OMB No.
0607-1013. Exp. 10/30/2023). Affected Public. Households.
Frequency. Households will be selected once to participate in a 20-minute survey. Respondent's Obligation. Voluntary. Legal Authority.
Title 13, United States Code, Sections 8(b), 182 and 196. This information collection request may be viewed at www.reginfo.gov. Follow the instructions to view the Department of Commerce collections currently under review by OMB. Written comments and recommendations for the proposed information collection should be submitted within 30 days of the publication of this notice on the following website www.reginfo.gov/âpublic/âdo/âPRAMain. Find this particular information collection by selecting âCurrently under 30-day ReviewâOpen for Public Commentsâ or by using the search function and entering either the title of the collection or the OMB Control Number 0607-1013.
Start Signature Sheleen Dumas, Department PRA Clearance Officer, Office of the Chief Information Officer, Commerce Department. End Signature End Preamble [FR Doc. 2021-20052 Filed 9-15-21. 8:45 am]BILLING CODE 3510-07-PStart Preamble Notice of amendment. The Secretary issues this amendment pursuant to section 319F-3 of the Public Health Service Act to expand the authority for certain Qualified Persons authorized to prescribe, dispense, and administer erectile dysfunction treatment therapeutics that are covered countermeasures under section VI of this Declaration.
This amendment is effective as of September 14, 2021. Start Further Info L. Paige Ezernack, Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201. 202-260-0365, paige.ezernack@hhs.gov. End Further Info End Preamble Start Supplemental Information The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes Start Printed Page 51161the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (Covered Countermeasures), except for claims involving âwillful misconductâ as defined in the PREP Act.
Under the PREP Act, a Declaration may be amended as circumstances warrant. The PREP Act was enacted on December 30, 2005, as Public Law 109-148, Division C, 変2. It amended the Public Health Service (PHS) Act, adding section 319F-3, which addresses liability immunity, and section 319F-4, which creates a compensation program. These sections are codified at 42 U.S.C. 247d-6d and 42 U.S.C.
247d-6e, respectively. Section 319F-3 of the PHS Act has been amended by the kamagra and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, enacted on March 13, 2013, and the erectile dysfunction Aid, Relief, and Economic Security (CARES) Act, Public Law 116-136, enacted on March 27, 2020, to expand Covered Countermeasures under the PREP Act. On January 31, 2020, the former Secretary, Alex M. Azar II, declared a public health emergency pursuant to section 319 of the PHS Act, 42 U.S.C. 247d, effective January 27, 2020, for the entire United States to aid in the response of the nation's health care community to the erectile dysfunction treatment outbreak.
Pursuant to section 319 of the PHS Act, the Secretary renewed that declaration effective on April 26, 2020, July 25, 2020, October 23, 2020, January 21, 2021, April 21, 2021 and July 20, 2021. On March 10, 2020, former Secretary Azar issued a Declaration under the PREP Act for medical countermeasures against erectile dysfunction treatment (85 FR 15198, Mar. 17, 2020) (the Declaration). On April 10, the former Secretary amended the Declaration under the PREP Act to extend liability immunity to covered countermeasures authorized under the CARES Act (85 FR 21012, Apr. 15, 2020).
On June 4, the former Secretary amended the Declaration to clarify that covered countermeasures under the Declaration include qualified countermeasures that limit the harm erectile dysfunction treatment might otherwise cause. (85 FR 35100, June 8, 2020). On August 19, the former Secretary amended the declaration to add additional categories of Qualified Persons and amend the category of disease, health condition, or threat for which he recommended the administration or use of the Covered Countermeasures. (85 FR 52136, Aug. 24, 2020).
On December 3, 2020, the former Secretary amended the declaration to incorporate Advisory Opinions of the General Counsel interpreting the PREP Act and the Secretary's Declaration and authorizations issued by the Department's Office of the Assistant Secretary for Health as an Authority Having Jurisdiction to respond. Added an additional category of qualified persons under Section V of the Declaration. Made explicit that the Declaration covers all qualified kamagra and epidemic products as defined under the PREP Act. Added a third method of distribution to provide liability protections for, among other things, private distribution channels. Made explicit that there can be situations where not administering a covered countermeasure to a particular individual can fall within the PREP Act and the Declaration's liability protections.
Made explicit that there are substantive federal legal and policy issues and interests in having a unified whole-of-nation response to the erectile dysfunction treatment kamagra among federal, state, local, and private-sector entities. Revised the effective time period of the Declaration. And republished the declaration in full. (85 FR 79190, Dec. 9, 2020).
On February 2, 2021, the Acting Secretary Norris Cochran amended the Declaration to add additional categories of Qualified Persons authorized to prescribe, dispense, and administer erectile dysfunction treatments that are covered countermeasures under the Declaration (86 FR 7872, Feb. 2, 2021). On February 16, 2021, the Acting Secretary amended the Declaration to add additional categories of Qualified Persons authorized to prescribe, dispense, and administer erectile dysfunction treatments that are covered countermeasures under the Declaration (86 FR 9516, Feb. 16, 2021) and on February 22, 2021, the Department filed a notice of correction to the February 2 and February 16 notices correcting effective dates stated in the Declaration, and correcting the description of qualified persons added by the February 16, 2021 amendment. (86 FR 10588, Feb.
22, 2021). On March 11, 2021, the Acting Secretary amended the Declaration to add additional Qualified Persons authorized to prescribe, dispense, and administer covered countermeasures under the Declaration. (86 FR 14462, Mar. 16, 2021). On August 4, 2021, Secretary Xavier Becerra amended the Declaration to clarify categories of Qualified Persons and to expand the scope of authority for certain Qualified Persons to administer seasonal influenza treatments to adults.
(86 FR 41977, Aug. 4, 2021). Secretary Xavier Becerra now amends section V of the Declaration to add subsection (i) to expand the scope of authority for licensed pharmacists to order and administer and qualified pharmacy technicians and pharmacy interns to administer erectile dysfunction treatment therapeutics subcutaneously, intramuscularly, or orally as authorized, approved, or licensed by the U.S. Food and Drug Administration (FDA). Accordingly, subsection V(i) authorizes.
(i) A State-licensed pharmacist who orders and administers, and pharmacy interns and qualified pharmacy technicians who administer (if the pharmacy intern or technician acts under the supervision of such pharmacist and the pharmacy intern or technician is licensed or registered by his or her State board of pharmacy)â[] FDA authorized, approved, or licensed erectile dysfunction treatment therapeutics. Such State-licensed pharmacists and the State-licensed or registered interns or technicians under their supervision are qualified persons only if the following requirements are met. I. The erectile dysfunction treatment therapeutic must be authorized, approved, or licensed by the FDA. Ii.
In the case of a licensed pharmacist ordering a erectile dysfunction treatment therapeutic, the therapeutic must be ordered for subcutaneous, intramuscular, or oral administration and in accordance with the FDA approval, authorization, or licensing;Start Printed Page 51162 iii. In the case of licensed pharmacists, qualified pharmacy technicians, and licensed or registered pharmacy interns administering the erectile dysfunction treatment therapeutic, the therapeutic must be administered subcutaneously, intramuscularly, or orally in accordance with the FDA approval, authorization, or licensing. Iv. In the case of qualified pharmacy technicians, the supervising pharmacist must be readily and immediately available to the qualified pharmacy technician. V.
In the case of erectile dysfunction treatment therapeutics administered through intramuscular or subcutaneous injections, the licensed pharmacist, licensed or registered pharmacy intern and qualified pharmacy technician must complete a practical training program that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of erectile dysfunction treatment therapeutics, the recognition and treatment of emergency reactions to erectile dysfunction treatment therapeutics, and any additional training required in the FDA approval, authorization, or licensing. Vi. The licensed pharmacist, licensed or registered pharmacy intern and qualified pharmacy technician must have a current certificate in basic cardiopulmonary resuscitation;â[] vii. The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers erectile dysfunction treatment therapeutics, including informing the patient's primary-care provider when available and complying with requirements with respect to reporting adverse events.
Viii. The licensed pharmacist, the licensed or registered pharmacy intern and the qualified pharmacy technician must comply with any applicable requirements (or conditions of use) that apply to the administration of erectile dysfunction treatment therapeutics. Description of This Amendment by Section Section V. Covered Persons Under the PREP Act and the Declaration, a âqualified personâ is a âcovered person.â Subject to certain limitations, a covered person is immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration or use of a covered countermeasure if a declaration under the PREP Act has been issued with respect to such countermeasure. ÂQualified personâ includes (A) a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed.
Or (B) âa person within a category of persons so identified in a declaration by the Secretaryâ under subsection (b) of the PREP Act. 42 U.S.C. 247d-6d(i)(8). By this amendment to the Declaration, the Secretary clarifies and expands the authorization for a category of persons who are qualified persons under section 247d-6d(i)(8)(B). First, the amendment clarifies that licensed pharmacists are authorized to order and administer and licensed or registered pharmacy interns and qualified pharmacy technicians are authorized to administer erectile dysfunction treatment therapeutics that are Covered Countermeasures under section VI of this Declaration.
The Secretary anticipates that there will be a need to increase the available pool of providers able to order and administer erectile dysfunction treatment therapeutics to address rising erectile dysfunction treatment cases, to expand patient access to these critical therapies, and to keep as many patients out of the hospital as possible. Rising erectile dysfunction treatment cases, largely attributable to the Delta variant, is a public health threat caused by erectile dysfunction treatment, placing additional strains on our healthcare system. Pharmacists, pharmacy technicians, and pharmacy interns are well positioned to increase access to therapeutics and have played a critical role in this kamagra in overseeing erectile dysfunction treatment testing and treatment administration. Given their skill set and training, as well as looming provider shortages, pharmacists, pharmacy technicians, and pharmacy interns will quickly expand access to erectile dysfunction treatment therapeutics. erectile dysfunction treatment therapeutics may be administered as intramuscular injections, subcutaneous injections, or orally and would require minimal, if any, additional training to administer beyond training pharmacists, pharmacy technicians, and pharmacy interns have already received for treatment administration, and would not place any undue training burden on providers.
As qualified persons, these licensed pharmacists, qualified pharmacy technicians and interns will be afforded liability protections in accordance with the PREP Act and the terms of this amended Declaration. Second, to the extent that any State law that would otherwise prohibit these healthcare professionals who are a âqualified personâ from prescribing, dispensing, or administering erectile dysfunction treatment therapeutics or other Covered Countermeasures, such law is preempted. On May 19, 2020, the Office of the General Counsel issued an advisory opinion concluding that, because licensed pharmacists are âqualified personsâ under this declaration, the PREP Act preempts state law that would otherwise prohibit such pharmacists from ordering and administering authorized erectile dysfunction treatment diagnostic tests.[] The opinion relied in part on the fact that the Congressional delegation of authority to the Secretary under the PREP Act to specify a class of persons, beyond those who are authorized to administer a covered countermeasure under State law, as âqualified personsâ would be rendered a nullity in the absence of such preemption. This opinion is incorporated by reference into this declaration. Based on the reasoning set forth in the May 19, 2020 advisory opinion, any State law that would otherwise prohibit a member of any of the classes of âqualified personsâ specified in this declaration from administering a covered countermeasure is likewise preempted.
In accordance with section 319F-3(i)(8)(A) of the Public Health Service Act, a State remains free to expand the universe of individuals authorized to administer Start Printed Page 51163covered countermeasures within its jurisdiction under State law. The plain language of the PREP Act makes clear that there is preemption of state law as described above. Furthermore, preemption of State law is justified to respond to the nation-wide public health emergency caused by erectile dysfunction treatment as it will enable States to quickly expand the vaccination, treatment and prevention workforces with additional qualified healthcare professionals where State or local requirements might otherwise inhibit or delay allowing these healthcare professionals to participate in the erectile dysfunction treatment countermeasure program. Amendments to Declaration Amended Declaration for Public Readiness and Emergency Preparedness Act Coverage for medical countermeasures against erectile dysfunction treatment. Section V of the March 10, 2020 Declaration under the PREP Act for medical countermeasures against erectile dysfunction treatment, as amended April 10, 2020, June 4, 2020, August 19, 2020, as amended and republished on December 3, 2020, as amended on February 2, 2021, as amended March 11, 2021, and as amended on August 4, 2021, is further amended pursuant to section 319F-3(b)(4) of the PHS Act as described below.
All other sections of the Declaration remain in effect as republished at 85 FR 79190 (Dec. 9, 2020). 1. Covered Persons, section V, delete in full and replace with. V.
Covered Persons 42 U.S.C. 247d-6d(i)(2), (3), (4), (6), (8)(A) and (B) Covered Persons who are afforded liability immunity under this Declaration are âmanufacturers,â âdistributors,â âprogram planners,â âqualified persons,â and their officials, agents, and employees, as those terms are defined in the PREP Act, and the United States. ÂOrderâ as used herein and in guidance issued by the Office of the Assistant Secretary for Healthâ[] means a provider medication order, which includes prescribing of treatments, or a laboratory order, which includes prescribing laboratory orders, if required. In addition, I have determined that the following additional persons are qualified persons. (a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in Section VII below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of an Emergency, as that term is defined in Section VII of this Declaration;[] (b) Any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act.
(c) Any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act. (d) A State-licensed pharmacist who orders and administers, and pharmacy interns and qualified pharmacy technicians who administer (if the pharmacy intern or technician acts under the supervision of such pharmacist and the pharmacy intern or technician is licensed or registered by his or her State board of pharmacy),[] (1) treatments that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule or (2) seasonal influenza treatment administered by qualified pharmacy technicians and interns that the ACIP recommends to persons aged 19 and older according to ACIP's standard immunization schedule. Or (3) FDA authorized or FDA licensed erectile dysfunction treatments to persons ages three or older. Such State-licensed pharmacists and the State-licensed or registered interns or technicians under their supervision are qualified persons only if the following requirements are met. I.
The treatment must be authorized, approved, or licensed by the FDA. Ii. In the case of a erectile dysfunction treatment, the vaccination must be ordered and administered according to ACIP's erectile dysfunction treatment recommendation(s). Iii. In the case of a childhood treatment, the vaccination must be ordered and administered according to ACIP's standard immunization schedule.
Iv. In the case of seasonal influenza treatment administered by qualified pharmacy technicians and interns, the vaccination must be ordered and administered according to ACIP's standard immunization schedule. V. In the case of pharmacy technicians, the supervising pharmacist must be readily and immediately available to the immunizing qualified pharmacy technician. Vi.
The licensed pharmacist must have completed the immunization Start Printed Page 51164training that the licensing State requires for pharmacists to order and administer treatments. If the State does not specify training requirements for the licensed pharmacist to order and administer treatments, the licensed pharmacist must complete a vaccination training program of at least 20 hours that is approved by the ACPE to order and administer treatments. Such a training program must include hands on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments. Vii. The licensed or registered pharmacy intern and qualified pharmacy technician must complete a practical training program that is approved by the ACPE.
This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments. Viii. The licensed pharmacist, licensed or registered pharmacy intern and qualified pharmacy technician must have a current certificate in basic cardiopulmonary resuscitation;â[] ix. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period. X.
The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers treatments, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (treatment registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a treatment must review the treatment registry or other vaccination records prior to administering a treatment. Xi. The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary care provider and refer patients as appropriate. And xii. The licensed pharmacist, the licensed or registered pharmacy intern and the qualified pharmacy technician must comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) erectile dysfunction treatment vaccination provider agreement and any other federal requirements that apply to the administration of erectile dysfunction treatment- 19 treatment(s).
(e) Healthcare personnel using telehealth to order or administer Covered Countermeasures for patients in a state other than the state where the healthcare personnel are licensed or otherwise permitted to practice. When ordering and administering Covered Countermeasures by means of telehealth to patients in a state where the healthcare personnel are not already permitted to practice, the healthcare personnel must comply with all requirements for ordering and administering Covered Countermeasures to patients by means of telehealth in the state where the healthcare personnel are permitted to practice. Any state law that prohibits or effectively prohibits such a qualified person from ordering and administering Covered Countermeasures by means of telehealth is preempted.[] Nothing in this Declaration shall preempt state laws that permit additional persons to deliver telehealth services. (f) Any healthcare professional or other individual who holds an active license or certification permitting the person to prescribe, dispense, or administer treatments under the law of any State as of the effective date of this amendment, or a pharmacist or pharmacy intern as authorized under the section V(d) of this Declaration, who prescribes, dispenses, or administers erectile dysfunction treatments that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies, other than the State in which the license or certification is held, in association with a erectile dysfunction treatment vaccination effort by a federal, State, local Tribal or territorial authority or by an institution in the State in which the erectile dysfunction treatment covered countermeasure is administered, so long as the license or certification of the healthcare professional has not been suspended or restricted by any licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of Inspector General, subject to. (i) Documentation of completion of the Centers for Disease Control and Prevention erectile dysfunction treatment (CDC) treatment Training Modulesâ[] and, for healthcare providers who are not currently practicing, documentation of an observation period by a currently practicing healthcare professional experienced in administering intramuscular injections, and for whom administering intramuscular injections is in their ordinary scope of practice, who confirms competency of the healthcare provider in preparation and administration of the erectile dysfunction treatment(s) to be administered.
(g) Any member of a uniformed service (including members of the National Guard in a Title 32 duty status) (hereafter in this paragraph âservice memberâ) or Federal government, employee, contractor, or volunteer who prescribes, administers, delivers, distributes or dispenses a Covered Countermeasure. Such Federal government service members, employees, contractors, or volunteers are qualified persons if the following requirement is met. The executive department or agency by or for which the Federal service member, employee, contractor, or volunteer is employed, contracts, or volunteers has authorized or could authorize that service member, employee, contractor, or volunteer to prescribe, administer, deliver, distribute, or dispense the Covered Countermeasure as any part of the duties or responsibilities of that service member, employee, contractor, or volunteer, even if those authorized duties or responsibilities ordinarily would not extend to members of the public or otherwise would be more limited in scope than the activities such service member, employees, contractors, Start Printed Page 51165or volunteers are authorized to carry out under this declaration. And (h) The following healthcare professionals and students in a healthcare profession training program subject to the requirements of this paragraph. 1.
Any midwife, paramedic, advanced or intermediate emergency medical technician (EMT), physician assistant, respiratory therapist, dentist, podiatrist, optometrist or veterinarian licensed or certified to practice under the law of any state who prescribes, dispenses, or administers erectile dysfunction treatments that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a erectile dysfunction treatment vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the erectile dysfunction treatment covered countermeasure is administered. 2. Any physician, advanced practice registered nurse, registered nurse, practical nurse, pharmacist, pharmacy intern, midwife, paramedic, advanced or intermediate EMT, respiratory therapist, dentist, physician assistant, podiatrist, optometrist, or veterinarian who has held an active license or certification under the law of any State within the last five years, which is inactive, expired or lapsed, who prescribes, dispenses, or administers erectile dysfunction treatments that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a erectile dysfunction treatment vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the erectile dysfunction treatment covered countermeasure is administered, so long as the license or certification was active and in good standing prior to the date it went inactive, expired or lapsed and was not revoked by the licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of Inspector General. 3. Any medical, nursing, pharmacy, pharmacy intern, midwife, paramedic, advanced or intermediate EMT, physician assistant, respiratory therapy, dental, podiatry, optometry or veterinary student with appropriate training in administering treatments as determined by his or her school or training program and supervision by a currently practicing healthcare professional experienced in administering intramuscular injections who administers erectile dysfunction treatments that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a erectile dysfunction treatment vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the erectile dysfunction treatment covered countermeasure is administered.
Subject to the following requirements. I. The treatment must be authorized, approved, or licensed by the FDA. Ii. Vaccination must be ordered and administered according to ACIP's erectile dysfunction treatment recommendation(s).
Iii. The healthcare professionals and students must have documentation of completion of the Centers for Disease Control and Prevention erectile dysfunction treatment Training Modules and, if applicable, such additional training as may be required by the State, territory, locality, or Tribal area in which they are prescribing, dispensing, or administering erectile dysfunction treatments. Iv. The healthcare professionals and students must have documentation of an observation period by a currently practicing healthcare professional experienced in administering intramuscular injections, and for whom administering vaccinations is in their ordinary scope of practice, who confirms competency of the healthcare provider or student in preparation and administration of the erectile dysfunction treatment(s) to be administered and, if applicable, such additional training as may be required by the State, territory, locality, or Tribal area in which they are prescribing, dispensing, or administering erectile dysfunction treatments. V.
The healthcare professionals and students must have a current certificate in basic cardiopulmonary resuscitation;â[] vi. The healthcare professionals and students must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers treatments, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (treatment registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a treatment must review the treatment registry or other vaccination records prior to administering a treatment. And vii. The healthcare professionals and students comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) erectile dysfunction treatment vaccination provider agreement and any other federal requirements that apply to the administration of erectile dysfunction treatment(s). (i) A State-licensed pharmacist who orders and administers, and pharmacy interns and qualified pharmacy technicians who administer (if the pharmacy intern or technician acts under the supervision of such pharmacist and the pharmacy intern or technician is licensed or registered by his or her State board of pharmacy)â[] FDA authorized, approved, or licensed erectile dysfunction treatment therapeutics.
Such State-licensed pharmacists and the State-licensed or registered interns or technicians under their supervision are Start Printed Page 51166qualified persons only if the following requirements are met. Ix. The erectile dysfunction treatment therapeutic must be authorized, approved, or licensed by the FDA.
Affected http://augenaerzte-georgstr.de/cialis-online-canada/ Public kamagra online in canada. Households. Frequency. Households will be selected kamagra online in canada once to participate in a 20-minute survey.
Respondent's Obligation. Voluntary. Legal Authority kamagra online in canada. Title 13, United States Code, Sections 8(b), 182 and 196.
This information collection request may be viewed at www.reginfo.gov. Follow the instructions to view the kamagra online in canada Department of Commerce collections currently under review by OMB. Written comments and recommendations for the proposed information collection should be submitted within 30 days of the publication of this notice on the following website www.reginfo.gov/âpublic/âdo/âPRAMain. Find this particular information collection by selecting âCurrently under 30-day ReviewâOpen for Public Commentsâ or by using the search function and entering either the title of the collection or the OMB Control Number 0607-1013.
Start Signature Sheleen Dumas, Department PRA Clearance kamagra online in canada Officer, Office of the Chief Information Officer, Commerce Department. End Signature End Preamble [FR Doc. 2021-20052 Filed 9-15-21. 8:45 am]BILLING kamagra online in canada CODE 3510-07-PStart Preamble Notice of amendment.
The Secretary issues this amendment pursuant to section 319F-3 of the Public Health Service Act to expand the authority for certain Qualified Persons authorized to prescribe, dispense, and administer erectile dysfunction treatment therapeutics that are covered countermeasures under section VI of this Declaration. This amendment is effective as of September 14, 2021. Start Further kamagra online in canada Info L. Paige Ezernack, Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201.
202-260-0365, paige.ezernack@hhs.gov. End Further Info End Preamble Start Supplemental Information The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes Start Printed Page 51161the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (Covered kamagra online in canada Countermeasures), except for claims involving âwillful misconductâ as defined in the PREP Act. Under the PREP Act, a Declaration may be amended as circumstances warrant. The PREP Act was enacted on December 30, 2005, as Public Law 109-148, Division C, §â2.
It amended the Public Health Service (PHS) Act, adding section 319F-3, which addresses liability immunity, and section 319F-4, which kamagra online in canada creates a compensation program. These sections are codified at 42 U.S.C. 247d-6d and 42 U.S.C. 247d-6e, respectively kamagra online in canada.
Section 319F-3 of the PHS Act has been amended by the kamagra and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, enacted on March 13, 2013, and the erectile dysfunction Aid, Relief, and Economic Security (CARES) Act, Public Law 116-136, enacted on March 27, 2020, to expand Covered Countermeasures under the PREP Act. On January 31, 2020, the former Secretary, Alex M. Azar II, declared a public health emergency pursuant kamagra online in canada to section 319 of the PHS Act, 42 U.S.C. 247d, effective January 27, 2020, for the entire United States to aid in the response of the nation's health care community to the erectile dysfunction treatment outbreak.
Pursuant to section 319 of the PHS Act, the Secretary renewed that declaration effective on April 26, 2020, July 25, 2020, October 23, 2020, January 21, 2021, April 21, 2021 and July 20, 2021. On March kamagra online in canada 10, 2020, former Secretary Azar issued a Declaration under the PREP Act for medical countermeasures against erectile dysfunction treatment (85 FR 15198, Mar. 17, 2020) (the Declaration). On April 10, the former Secretary amended the Declaration under the PREP Act to extend liability immunity to covered countermeasures authorized under the CARES Act (85 FR 21012, Apr.
15, 2020) kamagra online in canada. On June 4, the former Secretary amended the Declaration to clarify that covered countermeasures under the Declaration include qualified countermeasures that limit the harm erectile dysfunction treatment might otherwise cause. (85 FR 35100, June 8, 2020). On August 19, kamagra online in canada the former Secretary amended the declaration to add additional categories of Qualified Persons and amend the category of disease, health condition, or threat for which he recommended the administration or use of the Covered Countermeasures.
(85 FR 52136, Aug. 24, 2020). On December 3, 2020, the former Secretary amended the declaration to incorporate Advisory Opinions of the General Counsel interpreting the PREP Act and the Secretary's Declaration and authorizations issued by kamagra online in canada the Department's Office of the Assistant Secretary for Health as an Authority Having Jurisdiction to respond. Added an additional category of qualified persons under Section V of the Declaration.
Made explicit that the Declaration covers all qualified kamagra and epidemic products as defined under the PREP Act. Added a third method of distribution kamagra online in canada to provide liability protections for, among other things, private distribution channels. Made explicit that there can be situations where not administering a covered countermeasure to a particular individual can fall within the PREP Act and the Declaration's liability protections. Made explicit that there are substantive federal legal and policy issues and interests in having a unified whole-of-nation response to the erectile dysfunction treatment kamagra among federal, state, local, and private-sector entities.
Revised the effective time period kamagra online in canada of the Declaration. And republished the declaration in full. (85 FR 79190, Dec. 9, 2020) kamagra online in canada.
On February 2, 2021, the Acting Secretary Norris Cochran amended the Declaration to add additional categories of Qualified Persons authorized to prescribe, dispense, and administer erectile dysfunction treatments that are covered countermeasures under the Declaration (86 FR 7872, Feb. 2, 2021). On February 16, 2021, the Acting Secretary amended the Declaration to add additional categories of Qualified Persons authorized to prescribe, dispense, and administer erectile dysfunction treatment kamagra online in canada treatments that are covered countermeasures under the Declaration (86 FR 9516, Feb. 16, 2021) and on February 22, 2021, the Department filed a notice of correction to the February 2 and February 16 notices correcting effective dates stated in the Declaration, and correcting the description of qualified persons added by the February 16, 2021 amendment.
(86 FR 10588, Feb. 22, 2021) kamagra online in canada. On March 11, 2021, the Acting Secretary amended the Declaration to add additional Qualified Persons authorized to prescribe, dispense, and administer covered countermeasures under the Declaration. (86 FR 14462, Mar.
16, 2021) kamagra online in canada. On August 4, 2021, Secretary Xavier Becerra amended the Declaration to clarify categories of Qualified Persons and to expand the scope of authority for certain Qualified Persons to administer seasonal influenza treatments to adults. (86 FR 41977, Aug. 4, 2021) kamagra online in canada.
Secretary Xavier Becerra now amends section V of the Declaration to add subsection (i) to expand the scope of authority for licensed pharmacists to order and administer and qualified pharmacy technicians and pharmacy interns to administer erectile dysfunction treatment therapeutics subcutaneously, intramuscularly, or orally as authorized, approved, or licensed by the U.S. Food and Drug Administration (FDA). Accordingly, subsection kamagra online in canada V(i) authorizes. (i) A State-licensed pharmacist who orders and administers, and pharmacy interns and qualified pharmacy technicians who administer (if the pharmacy intern or technician acts under the supervision of such pharmacist and the pharmacy intern or technician is licensed or registered by his or her State board of pharmacy)â[] FDA authorized, approved, or licensed erectile dysfunction treatment therapeutics.
Such State-licensed pharmacists and the State-licensed or registered interns or technicians under their supervision are qualified persons only if the following requirements are met. I. The erectile dysfunction treatment therapeutic must be authorized, approved, or licensed by the FDA. Ii.
In the case of a licensed pharmacist ordering a erectile dysfunction treatment therapeutic, the therapeutic must be ordered for subcutaneous, intramuscular, or oral administration and in accordance with the FDA approval, authorization, or licensing;Start Printed Page 51162 iii. In the case of licensed pharmacists, qualified pharmacy technicians, and licensed or registered pharmacy interns administering the erectile dysfunction treatment therapeutic, the therapeutic must be administered subcutaneously, intramuscularly, or orally in accordance with the FDA approval, authorization, or licensing. Iv. In the case of qualified pharmacy technicians, the supervising pharmacist must be readily and immediately available to the qualified pharmacy technician.
V. In the case of erectile dysfunction treatment therapeutics administered through intramuscular or subcutaneous injections, the licensed pharmacist, licensed or registered pharmacy intern and qualified pharmacy technician must complete a practical training program that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of erectile dysfunction treatment therapeutics, the recognition and treatment of emergency reactions to erectile dysfunction treatment therapeutics, and any additional training required in the FDA approval, authorization, or licensing. Vi.
The licensed pharmacist, licensed or registered pharmacy intern and qualified pharmacy technician must have a current certificate in basic cardiopulmonary resuscitation;â[] vii. The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers erectile dysfunction treatment therapeutics, including informing the patient's primary-care provider when available and complying with requirements with respect to reporting adverse events. Viii. The licensed pharmacist, the licensed or registered pharmacy intern and the qualified pharmacy technician must comply with any applicable requirements (or conditions of use) that apply to the administration of erectile dysfunction treatment therapeutics.
Description of This Amendment by Section Section V. Covered Persons Under the PREP Act and the Declaration, a âqualified personâ is a âcovered person.â Subject to certain limitations, a covered person is immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration or use of a covered countermeasure if a declaration under the PREP Act has been issued with respect to such countermeasure. ÂQualified personâ includes (A) a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed. Or (B) âa person within a category of persons so identified in a declaration by the Secretaryâ under subsection (b) of the PREP Act.
42 U.S.C. 247d-6d(i)(8). By this amendment to the Declaration, the Secretary clarifies and expands the authorization for a category of persons who are qualified persons under section 247d-6d(i)(8)(B). First, the amendment clarifies that licensed pharmacists are authorized to order and administer and licensed or registered pharmacy interns and qualified pharmacy technicians are authorized to administer erectile dysfunction treatment therapeutics that are Covered Countermeasures under section VI of this Declaration.
The Secretary anticipates that there will be a need to increase the available pool of providers able to order and administer erectile dysfunction treatment therapeutics to address rising erectile dysfunction treatment cases, to expand patient access to these critical therapies, and to keep as many patients out of the hospital as possible. Rising erectile dysfunction treatment cases, largely attributable to the Delta variant, is a public health threat caused by erectile dysfunction treatment, placing additional strains on our healthcare system. Pharmacists, pharmacy technicians, and pharmacy interns are well positioned to increase access to therapeutics and have played a critical role in this kamagra in overseeing erectile dysfunction treatment testing and treatment administration. Given their skill set and training, as well as looming provider shortages, pharmacists, pharmacy technicians, and pharmacy interns will quickly expand access to erectile dysfunction treatment therapeutics.
erectile dysfunction treatment therapeutics may be administered as intramuscular injections, subcutaneous injections, or orally and would require minimal, if any, additional training to administer beyond training pharmacists, pharmacy technicians, and pharmacy interns have already received for treatment administration, and would not place any undue training burden on providers. As qualified persons, these licensed pharmacists, qualified pharmacy technicians and interns will be afforded liability protections in accordance with the PREP Act and the terms of this amended Declaration. Second, to the extent that any State law that would otherwise prohibit these healthcare professionals who are a âqualified personâ from prescribing, dispensing, or administering erectile dysfunction treatment therapeutics or other Covered Countermeasures, such law is preempted. On May 19, 2020, the Office of the General Counsel issued an advisory opinion concluding that, because licensed pharmacists are âqualified personsâ under this declaration, the PREP Act preempts state law that would otherwise prohibit such pharmacists from ordering and administering authorized erectile dysfunction treatment diagnostic tests.[] The opinion relied in part on the fact that the Congressional delegation of authority to the Secretary under the PREP Act to specify a class of persons, beyond those who are authorized to administer a covered countermeasure under State law, as âqualified personsâ would be rendered a nullity in the absence of such preemption.
This opinion is incorporated by reference into this declaration. Based on the reasoning set forth in the May 19, 2020 advisory opinion, any State law that would otherwise prohibit a member of any of the classes of âqualified personsâ specified in this declaration from administering a covered countermeasure is likewise preempted. In accordance with section 319F-3(i)(8)(A) of the Public Health Service Act, a State remains free to expand the universe of individuals authorized to administer Start Printed Page 51163covered countermeasures within its jurisdiction under State law. The plain language of the PREP Act makes clear that there is preemption of state law as described above.
Furthermore, preemption of State law is justified to respond to the nation-wide public health emergency caused by erectile dysfunction treatment as it will enable States to quickly expand the vaccination, treatment and prevention workforces with additional qualified healthcare professionals where State or local requirements might otherwise inhibit or delay allowing these healthcare professionals to participate in the erectile dysfunction treatment countermeasure program. Amendments to Declaration Amended Declaration for Public Readiness and Emergency Preparedness Act Coverage for medical countermeasures against erectile dysfunction treatment. Section V of the March 10, 2020 Declaration under the PREP Act for medical countermeasures against erectile dysfunction treatment, as amended April 10, 2020, June 4, 2020, August 19, 2020, as amended and republished on December 3, 2020, as amended on February 2, 2021, as amended March 11, 2021, and as amended on August 4, 2021, is further amended pursuant to section 319F-3(b)(4) of the PHS Act as described below. All other sections of the Declaration remain in effect as republished at 85 FR 79190 (Dec.
9, 2020). 1. Covered Persons, section V, delete in full and replace with. V.
Covered Persons 42 U.S.C. 247d-6d(i)(2), (3), (4), (6), (8)(A) and (B) Covered Persons who are afforded liability immunity under this Declaration are âmanufacturers,â âdistributors,â âprogram planners,â âqualified persons,â and their officials, agents, and employees, as those terms are defined in the PREP Act, and the United States. ÂOrderâ as used herein and in guidance issued by the Office of the Assistant Secretary for Healthâ[] means a provider medication order, which includes prescribing of treatments, or a laboratory order, which includes prescribing laboratory orders, if required. In addition, I have determined that the following additional persons are qualified persons.
(a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in Section VII below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of an Emergency, as that term is defined in Section VII of this Declaration;[] (b) Any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act. (c) Any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act. (d) A State-licensed pharmacist who orders and administers, and pharmacy interns and qualified pharmacy technicians who administer (if the pharmacy intern or technician acts under the supervision of such pharmacist and the pharmacy intern or technician is licensed or registered by his or her State board of pharmacy),[] (1) treatments that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule or (2) seasonal influenza treatment administered by qualified pharmacy technicians and interns that the ACIP recommends to persons aged 19 and older according to ACIP's standard immunization schedule. Or (3) FDA authorized or FDA licensed erectile dysfunction treatments to persons ages three or older.
Such State-licensed pharmacists and the State-licensed or registered interns or technicians under their supervision are qualified persons only if the following requirements are met. I. The treatment must be authorized, approved, or licensed by the FDA. Ii.
In the case of a erectile dysfunction treatment, the vaccination must be ordered and administered according to ACIP's erectile dysfunction treatment recommendation(s). Iii. In the case of a childhood treatment, the vaccination must be ordered and administered according to ACIP's standard immunization schedule. Iv.
In the case of seasonal influenza treatment administered by qualified pharmacy technicians and interns, the vaccination must be ordered and administered according to ACIP's standard immunization schedule. V. In the case of pharmacy technicians, the supervising pharmacist must be readily and immediately available to the immunizing qualified pharmacy technician. Vi.
The licensed pharmacist must have completed the immunization Start Printed Page 51164training that the licensing State requires for pharmacists to order and administer treatments. If the State does not specify training requirements for the licensed pharmacist to order and administer treatments, the licensed pharmacist must complete a vaccination training program of at least 20 hours that is approved by the ACPE to order and administer treatments. Such a training program must include hands on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments. Vii.
The licensed or registered pharmacy intern and qualified pharmacy technician must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments. Viii. The licensed pharmacist, licensed or registered pharmacy intern and qualified pharmacy technician must have a current certificate in basic cardiopulmonary resuscitation;â[] ix.
The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period. X. The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers treatments, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (treatment registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a treatment must review the treatment registry or other vaccination records prior to administering a treatment. Xi.
The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary care provider and refer patients as appropriate. And xii. The licensed pharmacist, the licensed or registered pharmacy intern and the qualified pharmacy technician must comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) erectile dysfunction treatment vaccination provider agreement and any other federal requirements that apply to the administration of erectile dysfunction treatment- 19 treatment(s). (e) Healthcare personnel using telehealth to order or administer Covered Countermeasures for patients in a state other than the state where the healthcare personnel are licensed or otherwise permitted to practice.
When ordering and administering Covered Countermeasures by means of telehealth to patients in a state where the healthcare personnel are not already permitted to practice, the healthcare personnel must comply with all requirements for ordering and administering Covered Countermeasures to patients by means of telehealth in the state where the healthcare personnel are permitted to practice. Any state law that prohibits or effectively prohibits such a qualified person from ordering and administering Covered Countermeasures by means of telehealth is preempted.[] Nothing in this Declaration shall preempt state laws that permit additional persons to deliver telehealth services. (f) Any healthcare professional or other individual who holds an active license or certification permitting the person to prescribe, dispense, or administer treatments under the law of any State as of the effective date of this amendment, or a pharmacist or pharmacy intern as authorized under the section V(d) of this Declaration, who prescribes, dispenses, or administers erectile dysfunction treatments that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies, other than the State in which the license or certification is held, in association with a erectile dysfunction treatment vaccination effort by a federal, State, local Tribal or territorial authority or by an institution in the State in which the erectile dysfunction treatment covered countermeasure is administered, so long as the license or certification of the healthcare professional has not been suspended or restricted by any licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of Inspector General, subject to. (i) Documentation of completion of the Centers for Disease Control and Prevention erectile dysfunction treatment (CDC) treatment Training Modulesâ[] and, for healthcare providers who are not currently practicing, documentation of an observation period by a currently practicing healthcare professional experienced in administering intramuscular injections, and for whom administering intramuscular injections is in their ordinary scope of practice, who confirms competency of the healthcare provider in preparation and administration of the erectile dysfunction treatment(s) to be administered.
(g) Any member of a uniformed service (including members of the National Guard in a Title 32 duty status) (hereafter in this paragraph âservice memberâ) or Federal government, employee, contractor, or volunteer who prescribes, administers, delivers, distributes or dispenses a Covered Countermeasure. Such Federal government service members, employees, contractors, or volunteers are qualified persons if the following requirement is met. The executive department or agency by or for which the Federal service member, employee, contractor, or volunteer is employed, contracts, or volunteers has authorized or could authorize that service member, employee, contractor, or volunteer to prescribe, administer, deliver, distribute, or dispense the Covered Countermeasure as any part of the duties or responsibilities of that service member, employee, contractor, or volunteer, even if those authorized duties or responsibilities ordinarily would not extend to members of the public or otherwise would be more limited in scope than the activities such service member, employees, contractors, Start Printed Page 51165or volunteers are authorized to carry out under this declaration. And (h) The following healthcare professionals and students in a healthcare profession training program subject to the requirements of this paragraph.
1. Any midwife, paramedic, advanced or intermediate emergency medical technician (EMT), physician assistant, respiratory therapist, dentist, podiatrist, optometrist or veterinarian licensed or certified to practice under the law of any state who prescribes, dispenses, or administers erectile dysfunction treatments that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a erectile dysfunction treatment vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the erectile dysfunction treatment covered countermeasure is administered. 2. Any physician, advanced practice registered nurse, registered nurse, practical nurse, pharmacist, pharmacy intern, midwife, paramedic, advanced or intermediate EMT, respiratory therapist, dentist, physician assistant, podiatrist, optometrist, or veterinarian who has held an active license or certification under the law of any State within the last five years, which is inactive, expired or lapsed, who prescribes, dispenses, or administers erectile dysfunction treatments that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a erectile dysfunction treatment vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the erectile dysfunction treatment covered countermeasure is administered, so long as the license or certification was active and in good standing prior to the date it went inactive, expired or lapsed and was not revoked by the licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of Inspector General.
3. Any medical, nursing, pharmacy, pharmacy intern, midwife, paramedic, advanced or intermediate EMT, physician assistant, respiratory therapy, dental, podiatry, optometry or veterinary student with appropriate training in administering treatments as determined by his or her school or training program and supervision by a currently practicing healthcare professional experienced in administering intramuscular injections who administers erectile dysfunction treatments that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a erectile dysfunction treatment vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the erectile dysfunction treatment covered countermeasure is administered. Subject to the following requirements. I.
The treatment must be authorized, approved, or licensed by the FDA. Ii. Vaccination must be ordered and administered according to ACIP's erectile dysfunction treatment recommendation(s). Iii.
The healthcare professionals and students must have documentation of completion of the Centers for Disease Control and Prevention erectile dysfunction treatment Training Modules and, if applicable, such additional training as may be required by the State, territory, locality, or Tribal area in which they are prescribing, dispensing, or administering erectile dysfunction treatments. Iv. The healthcare professionals and students must have documentation of an observation period by a currently practicing healthcare professional experienced in administering intramuscular injections, and for whom administering vaccinations is in their ordinary scope of practice, who confirms competency of the healthcare provider or student in preparation and administration of the erectile dysfunction treatment(s) to be administered and, if applicable, such additional training as may be required by the State, territory, locality, or Tribal area in which they are prescribing, dispensing, or administering erectile dysfunction treatments. V.
The healthcare professionals and students must have a current certificate in basic cardiopulmonary resuscitation;â[] vi. The healthcare professionals and students must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers treatments, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (treatment registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a treatment must review the treatment registry or other vaccination records prior to administering a treatment. And vii. The healthcare professionals and students comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) erectile dysfunction treatment vaccination provider agreement and any other federal requirements that apply to the administration of erectile dysfunction treatment(s).
(i) A State-licensed pharmacist who orders and administers, and pharmacy interns and qualified pharmacy technicians who administer (if the pharmacy intern or technician acts under the supervision of such pharmacist and the pharmacy intern or technician is licensed or registered by his or her State board of pharmacy)â[] FDA authorized, approved, or licensed erectile dysfunction treatment therapeutics. Such State-licensed pharmacists and the State-licensed or registered interns or technicians under their supervision are Start Printed Page 51166qualified persons only if the following requirements are met. Ix. The erectile dysfunction treatment therapeutic must be authorized, approved, or licensed by the FDA.
X. In the case of a licensed pharmacist ordering a erectile dysfunction treatment therapeutic, the therapeutic must be ordered for subcutaneous, intramuscular, or oral administration and in accordance with the FDA approval, authorization, or licensing. Xi. In the case of licensed pharmacists, qualified pharmacy technicians, and licensed or registered pharmacy interns administering the erectile dysfunction treatment therapeutic, the therapeutic must be administered subcutaneously, intramuscularly, or orally in accordance with the FDA approval, authorization, or licensing.
Xii. In the case of qualified pharmacy technicians, the supervising pharmacist must be readily and immediately available to the qualified pharmacy technician. Xiii. In the case of erectile dysfunction treatment therapeutics administered through intramuscular or subcutaneous injections, the licensed pharmacist, licensed or registered pharmacy intern and qualified pharmacy technician must complete a practical training program that is approved by the ACPE.
This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of erectile dysfunction treatment therapeutics, the recognition and treatment of emergency reactions to erectile dysfunction treatment therapeutics, and any additional training required in the FDA approval, authorization, or licensing. Xiv. The licensed pharmacist, licensed or registered pharmacy intern and qualified pharmacy technician must have a current certificate in basic cardiopulmonary resuscitation;â[] xv. The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers erectile dysfunction treatment therapeutics, including informing the patient's primary-care provider when available and complying with requirements with respect to reporting adverse events.
Xvi. The licensed pharmacist, the licensed or registered pharmacy intern and the qualified pharmacy technician must comply with any applicable requirements (or conditions of use) that apply to the administration of erectile dysfunction treatment therapeutics. Nothing in this Declaration shall be construed to affect the National treatment Injury Compensation Program, including an injured party's ability to obtain compensation under that program. Covered countermeasures that are subject to the National treatment Injury Compensation Program authorized under 42 U.S.C.
300aa-10 et seq. Are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program. All other terms and conditions of the Declaration apply to such covered countermeasures. 2.
Effective Time Period, section XII, delete in full and replace with. Liability protections for any respiratory protective device approved by NIOSH under 42 CFR part 84, or any successor regulations, through the means of distribution identified in Section VII(a) of this Declaration, begin on March 27, 2020 and extend through October 1, 2024. Liability protections for all other Covered Countermeasures identified in Section VI of this Declaration, through means of distribution identified in Section VII(a) of this Declaration, begin on February 4, 2020 and extend through October 1, 2024. Liability protections for all Covered Countermeasures administered and used in accordance with the public health and medical response of the Authority Having Jurisdiction, as identified in Section VII(b) of this Declaration, begin with a Declaration of Emergency as that term is defined in Section VII (except that, with respect to qualified persons who order or administer a routine childhood vaccination that ACIP recommends to persons ages three through 18 according to ACIP's standard immunization schedule, liability protections began on August 24, 2020), and last through (a) the final day the Declaration of Emergency is in effect, or (b) October 1, 2024, whichever occurs first.
Liability protections for all Covered Countermeasures identified in Section VII(c) of this Declaration begin on December 9, 2020 and last through (a) the final day the Declaration of Emergency is in effect or (b) October 1, 2024 whichever occurs first. Liability protections for Qualified Persons under section V(d) of the Declaration who are qualified pharmacy technicians and interns to seasonal influenza treatment to persons aged 19 and older begin on August 4, 2021. Liability protections for Qualified Persons under section V(f) of the Declaration begin on February 2, 2021, and last through October 1, 2024. Liability protections for Qualified Persons under section V(g) of the Declaration begin on February 16, 2021, and last through October 1, 2024.
Liability protections for Qualified Persons who are physicians, advanced practice registered nurses, registered nurses, or practical nurses under section V(h) of the Declaration begins on February 2, 2021 and last through October 1, 2024, with additional conditions effective as of March 11, 2021and liability protections for all other Qualified persons under section V(h) begins on March 11, 2021 and last through October 1, 2024. Liability protections for Qualified Persons under section V(i) of the Declaration who are licensed pharmacists to order and administer and qualified pharmacy technicians and licensed or registered pharmacy interns to administer erectile dysfunction treatment therapeutics begin on September 9, 2021. Authority. 42 U.S.C.
247d-6d. Start Signature Dated. September 9, 2021. Xavier Becerra, Secretary, U.S.
Department of Health and Human Services. End Signature End Supplemental Information [FR Doc.
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The sausages and hams they created had preservatives from a mixture of plants and fruits including rosemary, green tea and resveratrol â an extract taken from Japanese knotweed. The researchers then compared nitrite levels in participants' feces after they ate conventionally processed red meat, white meat kamagra oral jelly uk next day and the specially formulated products. The investigators found significantly lower nitrite levels in those who ate specially formulated cured meats.
"Surprisingly, the natural additives seemed to have some protective effects even when the red meat still contained nitrite," Kuhnle said in a university news release. "This suggests that natural additives could be used to reduce some of the potentially harmful effects of nitrite, even in foods where it is not possible to take out nitrite preservatives altogether." The findings were recently published in kamagra oral jelly uk next day the journal Molecular Nutrition &. Food Research.
More information MD Anderson Cancer Center has more about processed meat and cancer. SOURCE. University of Reading, news release, Sept.
21, 2021 Steven Reinberg Copyright © 2021 HealthDay. All rights reserved.
Latest Cancer kamagra online in canada News http://iidoctor.com/?post_type=wpcf7_contact_form&p=208 FRIDAY, Sept. 24, 2021 (HealthDay News) There's good news for health-conscious sausage and bacon lovers. A new study suggests the Japanese knotweed plant could be used to make healthier cured meats.
According to researchers, this fast-growing plant that invades gardens and buildings contains a chemical that could take the place of the preservative nitrite, which kamagra online in canada has been linked to cancer, in cured meats. That might not only make bacon safer to eat, but also cold cuts, sausages and hams. Diets high in nitrites have been linked to a higher risk of colon cancer.
"Our latest findings show that using natural kamagra online in canada additives in processed red meat reduces the creation of compounds in the body that are linked to cancer," said researcher Gunter Kuhnle. He is a professor of nutrition and food science at the University of Reading in the United Kingdom. Kuhnle and his team developed a processed red meat that includes natural additives that reduce nitrite added to preserve meats.
The sausages and hams they created had preservatives from a mixture of plants and fruits including rosemary, green tea and resveratrol â an extract taken from Japanese knotweed. The researchers then compared nitrite levels buy kamagra online cheap in participants' kamagra online in canada feces after they ate conventionally processed red meat, white meat and the specially formulated products. The investigators found significantly lower nitrite levels in those who ate specially formulated cured meats.
"Surprisingly, the natural additives seemed to have some protective effects even when the red meat still contained nitrite," Kuhnle said in a university news release. "This suggests that natural additives could be used to reduce some of the potentially harmful effects of nitrite, even in foods where it is not possible to take out nitrite preservatives altogether." The findings were recently published in the journal kamagra online in canada Molecular Nutrition &. Food Research.
More information MD Anderson Cancer Center has more about processed meat and cancer. SOURCE. University of Reading, news release, Sept.
21, 2021 Steven Reinberg Copyright © 2021 HealthDay. All rights reserved.
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