Meeting of the National Advisory Committee on Rural Health and Human Services, 54983-54984 [2021-21581]

Download as PDF Federal Register / Vol. 86, No. 190 / Tuesday, October 5, 2021 / Notices and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002, or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your requests. The draft guidance may also be obtained by mail by calling CBER at 1–800–835–4709 or 240–402– 8010. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Timothy McGovern, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6426, Silver Spring, MD 20993–0002, 240–402–0477, Timothy.McGovern@fda.hhs.gov; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240– 402–7911. Regarding the ICH: Jill Adleberg, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6364, Silver Spring, MD 20993–0002, 301–796–5259, Jill.Adleberg@fda.hhs.gov. SUPPLEMENTARY INFORMATION: lotter on DSK11XQN23PROD with NOTICES1 I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals’’. The guidance was prepared under the auspices of ICH. ICH has the mission of achieving greater regulatory harmonization worldwide to ensure that safe, effective, high-quality medicines are developed, registered, and maintained in the most resourceefficient manner. By harmonizing the regulatory requirements in regions around the world, ICH guidelines have substantially reduced duplicative clinical studies, prevented unnecessary animal studies, standardized the reporting of important safety information, standardized marketing application submissions, and made many other improvements in the quality of global drug development and manufacturing and the products available to patients. The six Founding Members of the ICH are FDA; the Pharmaceutical Research VerDate Sep<11>2014 18:56 Oct 04, 2021 Jkt 256001 and Manufacturers of America; the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; and the Japanese Pharmaceutical Manufacturers Association. The Standing Members of the ICH Association include Health Canada and Swissmedic. Additionally, the Membership of ICH has expanded to include other regulatory authorities and industry associations from around the world (refer to https://www.ich.org/). ICH works by involving technical experts from both regulators and industry parties in detailed technical harmonization work and the application of a science-based approach to harmonization through a consensusdriven process that results in the development of ICH guidelines. The regulators around the world are committed to consistently adopting these consensus-based guidelines, realizing the benefits for patients and for industry. As a Founding Regulatory Member of ICH, FDA plays a major role in the development of each of the ICH guidelines, which FDA then adopts and issues as guidance for industry. FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, they describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. In May 2021, the ICH Assembly endorsed the draft guideline entitled ‘‘S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals’’ and agreed that the guideline should be made available for public comment. The draft guideline is the product of the Safety Expert Working Group of the ICH. Comments about this draft will be considered by FDA and the Safety Expert Working Group. The draft guidance provides guidance on expanding the testing scheme for assessing human carcinogenic risk of small molecule pharmaceuticals by introducing an additional approach that is not described in the original S1B Guideline and also adds a plasma exposure ratio-based approach for setting the high dose in the rasH2-Tg mouse model. This draft guidance has been left in the original ICH format. The final guidance will be reformatted and edited to conform with FDA’s good guidance practices regulation (21 CFR 10.115) and style before publication. The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals’’. It PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 54983 does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501– 3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR part 312 have been approved under OMB control number 0910–0014; the collections of information in 21 CFR part 314 have been approved under OMB control number 0910–0001. III. Electronic Access Persons with access to the internet may obtain the draft guidance at https://www.regulations.gov, https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ regulatory-information/search-fdaguidance-documents, or https:// www.fda.gov/vaccines-blood-biologics/ guidance-compliance-regulatoryinformation-biologics/biologicsguidances. Dated: September 30, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–21692 Filed 10–4–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Meeting of the National Advisory Committee on Rural Health and Human Services Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: In accordance with the Federal Advisory Committee Act, this notice announces the Secretary’s National Advisory Committee on Rural Health and Human Services (NACRHHS) has scheduled a public meeting. Information about NACRHHS SUMMARY: E:\FR\FM\05OCN1.SGM 05OCN1 54984 Federal Register / Vol. 86, No. 190 / Tuesday, October 5, 2021 / Notices and the agenda for this meeting can be found on the NACRHHS website at https://www.hrsa.gov/advisorycommittees/rural-health/. DATES: • Monday, October 25, 2021, 12:00 p.m.–5:30 p.m. Eastern Time (ET); • Tuesday, October 26, 2021, 12:30 p.m.–4:15 p.m. ET; and • Wednesday, October 27, 2021, 12:30 p.m.–4:30 p.m. ET. FOR FURTHER INFORMATION CONTACT: lotter on DSK11XQN23PROD with NOTICES1 Steven Hirsch, Administrative Coordinator at the Federal Office of Rural Health Policy, HRSA, 5600 Fishers Lane, 17W59D, Rockville, Maryland 20857; (301) 443–7322; or shirsch@hrsa.gov. SUPPLEMENTARY INFORMATION: NACRHHS provides advice and recommendations to the Secretary of HHS (Secretary) on policy, program development, and other matters of significance concerning both rural health and rural human services. At this meeting, NACRHHS will discuss Behavioral Health and Primary Care Integration in Rural America and recommendations to the Secretary on designation of a new type of provider, the Rural Emergency Hospital. Members of the public will have the opportunity to provide comments. Public participants wishing to provide oral comments must submit a written version of their statement at least three business days in advance of the scheduled meeting. Oral comments will be honored in the order they are requested and may be limited as time permits. Public participants wishing to offer a written statement should send it to Steven Hirsch, using the contact information above, at least 3 business days prior to the meeting. Individuals who plan to attend and need special assistance or another reasonable accommodation should notify Steven Hirsch at the address and phone number listed above at least 10 business days prior to the meeting. BILLING CODE 4165–15–P VerDate Sep<11>2014 18:56 Oct 04, 2021 Jkt 256001 Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. AGENCY: This meeting will be held via webinar. While this meeting is open to the public, advance registration is required. Please register online at https://www.surveymonkey.com/r/ WLSYQS5 by the deadline of 12:00 p.m. ET on October, 24, 2021. Instructions on how to access the meeting via Zoom will be provided upon registration. [FR Doc. 2021–21581 Filed 10–4–21; 8:45 am] Health Resources and Services Administration Meeting of the Advisory Committee on Heritable Disorders in Newborns and Children ADDRESSES: Maria G. Button, Director, Executive Secretariat. DEPARTMENT OF HEALTH AND HUMAN SERVICES In accordance with the Public Health Service Act and the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC or Committee) has scheduled a public meeting. Information about ACHDNC and the agenda for this meeting can be found on ACHDNC website at https://www.hrsa.gov/ advisory-committees/heritabledisorders/. DATES: Tuesday, November 9, 2021, from 10:00 a.m. to 3:00 p.m. Eastern Time (ET) and Wednesday, November 10, 2021, from 10:00 a.m. to 3:00 p.m. ET. ADDRESSES: This meeting will be held via webinar. While this meeting is open to the public, advance registration is required. Please register online at https:// www.achdncmeetings.org/registration/ by 12:00 p.m. ET on November 8, 2021. Instructions on how to access the meeting via webcast will be provided upon registration. FOR FURTHER INFORMATION CONTACT: Alaina Harris, Maternal and Child Health Bureau, HRSA, 5600 Fishers Lane, Room 18W66, Rockville, Maryland 20857; (301) 443–0721; or ACHDNC@hrsa.gov. SUPPLEMENTARY INFORMATION: ACHDNC provides advice and recommendations to the Secretary of Health and Human Services (Secretary) on the development of newborn screening activities, technologies, policies, guidelines, and programs for effectively reducing morbidity and mortality in newborns and children having, or at risk for, heritable disorders. ACHDNC reviews and reports regularly on newborn and childhood screening practices, recommends improvements in the national newborn and childhood screening programs, and fulfills requirements stated in the authorizing legislation. In addition, ACHDNC’s recommendations regarding inclusion of additional conditions for screening on the Recommended Uniform Screening Panel, following adoption by the SUMMARY: PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 Secretary, are evidence-informed preventive health services provided for in the comprehensive guidelines supported by HRSA pursuant to section 2713 of the Public Health Service Act (42 U.S.C. 300gg–13). Under this provision, non-grandfathered group health plans and health insurance issuers offering group or individual health insurance are required to provide insurance coverage without cost-sharing (a co-payment, co-insurance, or deductible) for preventive services for plan years (i.e., policy years) beginning on or after the date that is 1 year from the Secretary’s adoption of the condition for screening. During the November 9–10, 2021, meeting, ACHDNC will hear from experts in the fields of public health, medicine, heritable disorders, rare disorders, and newborn screening. Agenda items include the following: (1) The Committee will vote on whether or not to approve the following updates to the Committee’s evidencebased review and decision-making process: The condition nomination form, methods for assessing published and unpublished evidence, and additional guidance for the Committee’s decision matrix. (2) A presentation on phase two of the Mucopolysaccharidosis type II evidence review; (3) A presentation on phase one of the Guanidinoacetate methyltransferase deficiency evidence review; (4) A Krabbe disease nomination overview; (5) A possible Committee vote on whether to move Krabbe disease forward to a full evidence review; and (6) Workgroup updates. The agenda for this meeting does not include any vote or decision to recommend a condition for inclusion in the Recommended Uniform Screening Panel. As noted in the agenda items, the Committee may hold a vote on whether or not to recommend a nominated condition (Krabbe disease) to full evidence review, and will hear presentations on evidence review of Mucopolysaccharidosis type II and Guanidinoacetate methyltransferase deficiency, any of which may lead to such a recommendation at a future time. Agenda items are subject to change as priorities dictate. Information about ACHDNC, including a roster of members and past meeting summaries, is also available on the ACHDNC website. Members of the public also will have the opportunity to provide comments. Public participants providing general oral comments may submit written statements in advance of the scheduled meeting. Oral comments will be E:\FR\FM\05OCN1.SGM 05OCN1

Agencies

[Federal Register Volume 86, Number 190 (Tuesday, October 5, 2021)]
[Notices]
[Pages 54983-54984]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21581]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Meeting of the National Advisory Committee on Rural Health and 
Human Services

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services (HHS).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: In accordance with the Federal Advisory Committee Act, this 
notice announces the Secretary's National Advisory Committee on Rural 
Health and Human Services (NACRHHS) has scheduled a public meeting. 
Information about NACRHHS

[[Page 54984]]

and the agenda for this meeting can be found on the NACRHHS website at 
https://www.hrsa.gov/advisory-committees/rural-health/.

DATES: 
     Monday, October 25, 2021, 12:00 p.m.-5:30 p.m. Eastern 
Time (ET);
     Tuesday, October 26, 2021, 12:30 p.m.-4:15 p.m. ET; and
     Wednesday, October 27, 2021, 12:30 p.m.-4:30 p.m. ET.

ADDRESSES: This meeting will be held via webinar. While this meeting is 
open to the public, advance registration is required. Please register 
online at https://www.surveymonkey.com/r/WLSYQS5 by the deadline of 
12:00 p.m. ET on October, 24, 2021. Instructions on how to access the 
meeting via Zoom will be provided upon registration.

FOR FURTHER INFORMATION CONTACT: Steven Hirsch, Administrative 
Coordinator at the Federal Office of Rural Health Policy, HRSA, 5600 
Fishers Lane, 17W59D, Rockville, Maryland 20857; (301) 443-7322; or 
[email protected].

SUPPLEMENTARY INFORMATION: NACRHHS provides advice and recommendations 
to the Secretary of HHS (Secretary) on policy, program development, and 
other matters of significance concerning both rural health and rural 
human services.
    At this meeting, NACRHHS will discuss Behavioral Health and Primary 
Care Integration in Rural America and recommendations to the Secretary 
on designation of a new type of provider, the Rural Emergency Hospital.
    Members of the public will have the opportunity to provide 
comments. Public participants wishing to provide oral comments must 
submit a written version of their statement at least three business 
days in advance of the scheduled meeting. Oral comments will be honored 
in the order they are requested and may be limited as time permits. 
Public participants wishing to offer a written statement should send it 
to Steven Hirsch, using the contact information above, at least 3 
business days prior to the meeting.
    Individuals who plan to attend and need special assistance or 
another reasonable accommodation should notify Steven Hirsch at the 
address and phone number listed above at least 10 business days prior 
to the meeting.

Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2021-21581 Filed 10-4-21; 8:45 am]
BILLING CODE 4165-15-P