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

21 CFR part Topic OMB control 

No. 

807, subpart E ............................................................................ Premarket Notification ................................................................ 0910–0120 

800, 801, and 809 ...................................................................... Medical Device Labeling Regulations ........................................ 0910–0485 

Dated: December 28, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–29081 Filed 1–4–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–D–2199] 

Investigational New Drug Submissions 

for Individualized Antisense 

Oligonucleotide Drug Products: 

Administrative and Procedural 

Recommendations; Draft Guidance for 

Sponsor-Investigators; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled ‘‘IND 

Submissions for Individualized 

Antisense Oligonucleotide Drug 

Products: Administrative and 

Procedural Recommendations.’’ FDA is 

publishing this draft guidance to help 

sponsor-investigators (hereafter referred 

to as sponsors) developing 

individualized antisense 

oligonucleotide (ASO) drug products for 

a severely debilitating or life-threatening 

genetic disease. Most often, individuals 

with such diseases will not have 

adequate alternative therapy available 

for treating their disease. This draft 

guidance is intended to help sponsors of 

such development programs, who may 

be relatively unfamiliar with FDA 

regulations, processes, and practices, 

with the administrative and procedural 

aspects of interacting with FDA, 

including seeking feedback from FDA 

on their development programs and 

making regulatory submissions related 

to these development programs. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by March 8, 2021 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

Electronic Submission 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2020–D–2199 for ‘‘IND Submissions for 

Individualized Antisense 

Oligonucleotide Drug Products: 

Administrative and Procedural 

Recommendations.’’ Received 

comments will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 


jbell on DSKJLSW7X2PROD with NOTICES
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