Federal Register / Vol. 86, No. 2 / Tuesday, January 5, 2021 / Notices 315 

FOR FURTHER INFORMATION CONTACT: 

Colleen Locicero, Office of New Drugs, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Avenue, Silver Spring, MD 20903, 301– 

796–1114. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘IND Submissions for Individualized 

Antisense Oligonucleotide Drug 

Products: Administrative and 

Procedural Recommendations.’’ This 

draft guidance is intended to help 

sponsors developing individualized 

ASO drug products for a severely 

debilitating or life-threatening genetic 

disease. 

The draft guidance addresses the 

approach for obtaining feedback from 

FDA, the expectations and process for 

making regulatory submissions to FDA, 

and high-level recommendations related 

to the requirement for institutional 

review board review of protocols for 

trials of individualized ASO drug 

products and the informed consent of 

participants. The draft guidance 

discusses the importance of early 

interaction with FDA, submission 

expectations for pre-investigational new 

drug (IND) meeting packages and IND 

applications, and ethical and human 

subject protection considerations. 

The draft guidance is intended to help 

sponsors of such development 

programs, who may be relatively 

unfamiliar with FDA regulations, 

processes, and practices, seek feedback 

from FDA on their development 

programs and make regulatory 

submissions related to these 

development programs. The draft 

guidance is expected to facilitate the 

preparation of adequate pre-IND and 

IND submissions for review by the 

Agency, which may help enable prompt 

initiation of the investigation. 

This draft guidance represents the 

first of several guidances FDA intends to 

publish to advise and help sponsors 

developing individualized ASO drug 

products for patients who have severely 

debilitating or life-threatening diseases 

or conditions and no adequate 

alternative therapy available to them to 

treat their disease or condition. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on ‘‘IND Submissions for Individualized 

Antisense Oligonucleotide Drug 

Products: Administrative and 

Procedural Recommendations.’’ It 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 (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 for the 

submission of IND applications, 

amendments, and safety reports; for 

investigator brochures; and for 

requesting a pre-IND meeting have been 

approved under OMB control number 

0910–0014; the collections of 

information for paper submissions of 

Form FDA 3500A have been approved 

under OMB control number 0910–0291; 

the collections of information for 

electronic submissions of Form FDA 

3500 have been approved under OMB 

control number 0910–0645; the 

collections of information in 21 CFR 

parts 50 and 56 for obtaining informed 

consent for prospective patients have 

been approved under OMB control 

number 0910–0755. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs or https://

www.regulations.gov. 

Dated: December 23, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–29119 Filed 1–4–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Advisory Council on Alzheimer’s 

Research, Care, and Services; Meeting 

AGENCY: Assistant Secretary for 

Planning and Evaluation, HHS. 

ACTION: Notice of meeting. 

SUMMARY: This notice announces the 

public meeting of the Advisory Council 

on Alzheimer’s Research, Care, and 

Services (Advisory Council). The 

Advisory Council provides advice on 

how to prevent or reduce the burden of 

Alzheimer’s disease and related 

dementias on people with the disease 

and their caregivers. During the January 

25, 2021 meeting the Advisory Council 

will hear presentations on the impact of 

COVID–19 on people with dementia, 

health disparities in dementia research, 

and the implications of new 

technologies to identify Alzheimer’s 

disease through a blood tests. 

DATES: The meeting will be held on 

January 25, 2021 from 1:00 p.m. to 4:30 

p.m. EST. 

ADDRESSES: The meeting will be virtual, 

streaming at http://www.hhs.gov/live. 

Comments: Time is allocated on the 

agenda to hear public comments from 

4:00 p.m. to 4:30 p.m. The time for oral 

comments will be limited to two (2) 

minutes per individual. In order to 

provide a public comment, please 

register by emailing your name to 

napa@hhs.gov by Thursday, January 21. 

Registered commenters will receive both 

a dial-in number and a link to join the 

meeting virtually; individuals will have 

the choice to either join virtually via the 

link, or to call in only by using the dialin number. Note: There may be a 30–45 

second delay in the livestream video 

presentation of the conference. For this 

reason, if you have pre-registered to 

submit a public comment, it is 

important to connect to the meeting by 

3:45 p.m. to ensure that you do not miss 

your name and allotted time when 

called. If you miss your name and 

allotted time to speak, you may not be 

able to make your public comment. All 

participant audio lines will be muted for 

the duration of the meeting and only 

unmuted by the Host at the time of the 

participant’s public comment. Should 

you have questions during the session 

email napa@hhs.gov and someone will 

respond to your message as quickly as 

possible. 

In order to ensure accuracy, please 

submit a written copy of oral comments 

for the record by emailing napa@

hhs.gov by Tuesday, January 26. These 

comments will be shared on the website 

and reflected in the meeting minutes. 

In lieu of oral comments, formal 

written comments may be submitted for 

the record by Tuesday, January 26 to 

Helen Lamont, Ph.D., OASPE, 200 

Independence Avenue SW, Room 424E, 

Washington, DC 20201. Comments may 

also be sent to napa@hhs.gov. Those 

submitting written comments should 

identify themselves and any relevant 

organizational affiliations. 

FOR FURTHER INFORMATION CONTACT: 

Helen Lamont, 202–260–6075, 

helen.lamont@hhs.gov. Note: The 

meeting will be available to the public 

live at www.hhs.gov/live. 


jbell on DSKJLSW7X2PROD with NOTICES
316 Federal Register / Vol. 86, No. 2 / Tuesday, January 5, 2021 / Notices 

SUPPLEMENTARY INFORMATION: Notice of 

these meetings is given under the 

Federal Advisory Committee Act (5 

U.S.C. App. 2, section 10(a)(1) and 

(a)(2)). Topics of the Meeting: Impact of 

COVID–19 on people with dementia, 

health disparities in dementia research, 

and the implications of new 

technologies to identify Alzheimer’s 

disease through a blood tests. 

Procedure and Agenda: The meeting 

will be webcast at www.hhs.gov/live and 

video recordings will be added to the 

National Alzheimer’s Project Act 

website when available, after the 

meeting. 

Authority: 42 U.S.C. 11225; Section 2(e)(3) 

of the National Alzheimer’s Project Act. The 

panel is governed by provisions of Public 

Law 92–463, as amended (5 U.S.C. Appendix 

2), which sets forth standards for the 

formation and use of advisory committees. 

Dated: December 21, 2020. 

Brenda Destro, 

Deputy Assistant Secretary for Planning and 

Evaluation, Office of Human Services Policy. 

[FR Doc. 2020–29141 Filed 1–4–21; 8:45 am] 

BILLING CODE 4150–05–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public as indicated below in accordance 

with the provisions set forth in section 

552b(c)(6), Title 5 U.S.C., as amended 

for the review, discussion, and 

evaluation of individual intramural 

programs and projects conducted by the 

National Heart, Lung, and Blood 

Institute, including consideration of 

personnel qualifications and 

performance, and the competence of 

individual investigators, the disclosure 

of which would constitute a clearly 

unwarranted invasion of personal 

privacy. 

Name of Committee: Board of Scientific 

Counselors, NHLBI. 

Date: February 1, 2021. 

Time: 8:45 a.m. to 6:00 p.m. 

Agenda: To review and evaluate personnel 

qualifications and performance, and 

competence of individual investigators. 

Place: National Institutes of Health, 

Building 10, 10 Center Drive, Bethesda, MD 

20892 (Virtual Meeting). 

Contact Person: Robert S. Balaban, Ph.D., 

Scientific Director, Division of Intramural 

Research, National Institutes of Health, 

NHLBI Building 10, CRC, 4th Floor, Room 

1581, 10 Center Drive, Bethesda, MD 20892, 

(301) 496–2116, balabanr@nhlbi.nih.gov. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

In the interest of security, NIH has 

instituted stringent procedures for entrance 

onto the NIH campus. All visitor vehicles, 

including taxicabs, hotel, and airport shuttles 

will be inspected before being allowed on 

campus. Visitors will be asked to show one 

form of identification (for example, a 

government-issued photo ID, driver’s license, 

or passport) and to state the purpose of their 

visit. 

Information is also available on the 

Institute’s/Center’s home page: 

www.nhlbi.nih.gov/meetings/index.htm, 

where an agenda and any additional 

information for the meeting will be posted 

when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: December 29, 2020. 

David W. Freeman, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2020–29124 Filed 1–4–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Initial Review Group; Diabetes, 

Endocrinology and Metabolic Diseases DDK– 

B Subcommittee. 

Date: March 10–12, 2021. 

Time: 10:00 a.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892 (Video 

Meeting). 

Contact Person: Charlene J. Repique, Ph.D., 

Scientific Review Officer, Review Branch, 

DEA, NIDDK, National Institutes of Health, 

Room 7347, 6707 Democracy Boulevard, 

Bethesda, MD 20892–5452, (301) 594–7791, 

charlene.repique@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.847, Diabetes, 

Endocrinology and Metabolic Research; 

93.848, Digestive Diseases and Nutrition 

Research; 93.849, Kidney Diseases, Urology 

and Hematology Research, National Institutes 

of Health, HHS) 

Dated: December 29, 2020. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2020–29148 Filed 1–4–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Aging; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute on 

Aging Special Emphasis Panel; Preclinical 

Development of Aging Therapeutics. 

Date: February 18, 2021. 

Time: 11:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute on Aging, 

Gateway Building, 7201 Wisconsin Avenue, 

Bethesda, MD 20892 (Video Meeting). 

Contact Person: Birgit Neuhuber, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, National Institute on Aging, National 

Institutes of Health, 7201 Wisconsin Avenue, 

Gateway Building, Suite 2W200, Bethesda, 

MD 20892, (301) 480–1266, neuhuber@

ninds.nih.gov. 


jbell on DSKJLSW7X2PROD with NOTICES