Federal Register / Vol. 86, No. 31 / Thursday, February 18, 2021 / Notices 10095 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Digestive 

Sciences Small Business Activities. 

Date: March 18, 2021. 

Time: 9:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Santanu Banerjee, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institute of 

Health, 6701 Rockledge Drive, Room 2106, 

Bethesda, MD 20892, (301) 435–5947, 

banerjees5@mail.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel;Small 

Business: Cardiovascular and Surgical 

Devices. 

Date: March 18–19, 2021. 

Time: 9:30 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Jan Li, MD, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review National Institutes of 

Health, 6701 Rockledge Drive, Room 5106, 

Bethesda, MD 20892, 301.402.9607, Jan.Li@

nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Small 

Business (HD21–020): Non-invasive 

Diagnostics to Improve Gynecologic Health. 

Date: March 18, 2021. 

Time: 10:00 a.m. to 12:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Yunshang Piao, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institute of 

Health, 6701 Rockledge Drive, Room 6184, 

Bethesda, MD 20892, 301.402.8402 piaoy3@

mail.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; RFA Panel: 

NIH Director’s Early Independence Award 

Review. 

Date: March 18–19, 2021. 

Time: 10:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892. 

Contact Person: Suzanne Ryan, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive Room 3139, 

MSC 7770, Bethesda, MD 20892, (301) 435– 

1712 ryansj@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Member 

Conflict: Skeletal Muscle Physiology and 

Rehabilitation. 

Date: March 18, 2021. 

Time: 1:00 p.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Srikanth Ranganathan, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review National Institutes of 

Health, 6701 Rockledge Drive,, Room 4214, 

MSC 7802, Bethesda, MD 20892, (301) 435– 

1787, srikanth.ranganathan@nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; PAR 

Panel—Fertility Status as a Marker for 

Overall Health. 

Date: March 18, 2021. 

Time: 12:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Hui Chen, MD, Scientific 

Review Officer, Center for Scientific Review 

National Institutes of Health, 6701 Rockledge 

Drive, Room 6164, Bethesda, MD 20892, 301– 

435–1044, chenhui@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review, Special Emphasis Panel; Small 

Business: Endocrinology, Metabolism, 

Nutrition and Reproductive Sciences. 

Date: March 18–19, 2021. 

Time: 12:30 p.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Yunshang Piao, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review National Institute of 

Health, 6701 Rockledge Drive, Room 6184, 

Bethesda, MD 20892, 301.402.8402, piaoy3@

mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: February 11, 2021. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–03189 Filed 2–17–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–D–0575] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Expedited 

Programs for Serious Conditions— 

Drugs and Biologics 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by March 22, 

2021. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0765. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Expedited Programs for Serious 

Conditions—Drugs and Biologics 

OMB Control Number 0910–0765— 

Extension 

This information collection supports 

Agency regulations and associated 

guidance pertaining to expedited 

programs for serious conditions. The 

purpose of our regulations in 21 CFR 

part 312, subpart E is to establish 

procedures designed to expedite the 

development, evaluation, and marketing 

of new therapies intended to treat 

persons with life-threatening and 

severely debilitating illnesses, 

especially where no satisfactory 

alternative therapy exists. While the 

statutory standards of safety and 

effectiveness apply to all drugs, the 

many kinds of drugs that are subject to 

them, and the wide range of uses for 

those drugs, demand flexibility in 

applying the standards. 

We have developed the guidance for 

industry entitled ‘‘Expedited Programs 

for Serious Conditions—Drugs and 

Biologics’’ as a single resource for 

information on FDA’s policies and 

procedures related to the following 


jbell on DSKJLSW7X2PROD with NOTICES
10096 Federal Register / Vol. 86, No. 31 / Thursday, February 18, 2021 / Notices 

expedited programs for serious 

conditions: (1) Fast track designation, 

(2) breakthrough therapy designation, 

(3) accelerated approval, and (4) priority 

review designation. The guidance 

describes threshold criteria generally 

applicable to expedited programs, 

including what is meant by serious 

condition, unmet medical need, and 

available therapy. The guidance 

addresses the applicability of expedited 

programs to rare diseases, clarification 

on available therapy, and additional 

detail on possible flexibility in 

manufacturing and product quality. It 

also clarifies the qualifying criteria for 

breakthrough therapy designation and 

provides examples of surrogate 

endpoints and intermediate clinical 

endpoints used to support accelerated 

approval. 

A sponsor or applicant who seeks fast 

track designation is required to submit 

to us a request showing that the drug 

product: (1) Is intended for a serious or 

life-threatening condition and (2) has 

the potential to address an unmet 

medical need. We expect that most 

information to support a designation 

request will have been gathered under 

existing requirements for preparing an 

investigational new drug application 

(IND), new drug application (NDA), or 

biologics license application (BLA). If 

such information has already been 

submitted to us, the information may be 

summarized in the fast track designation 

request. A designation request should 

include, where applicable, additional 

information not specified elsewhere by 

statute or regulation. For example, 

additional information may be needed 

to show that a product has the potential 

to address an unmet medical need 

where an approved therapy exists for 

the serious or life-threatening condition 

to be treated. Such information may 

include clinical data, published reports, 

summaries of data and reports, and a list 

of references. The amount of 

information and discussion in a 

designation request need not be 

voluminous, but it should be sufficient 

to permit a reviewer to assess whether 

the criteria for fast track designation 

have been met. 

After we make a fast track 

designation, a sponsor or applicant may 

submit a premeeting package that may 

include additional information 

supporting a request to participate in 

certain fast track programs. The 

premeeting package serves as 

background information for the meeting 

and should support the intended 

objectives of the meeting. As with the 

request for fast track designation, we 

expect that most sponsors or applicants 

will have gathered such information to 

meet existing requirements for 

preparing an IND, an NDA, or a BLA. 

These may include descriptions of 

clinical safety and efficacy trials not 

conducted under an IND (e.g., foreign 

studies) and information to support a 

request for accelerated approval. If such 

information has already been submitted 

to us, the information may be 

summarized in the premeeting package. 

We also developed the guidance 

document entitled ‘‘Expedited Programs 

for Regenerative Medicine Therapies for 

Serious Conditions.’’ The guidance 

provides sponsors engaged in the 

development of regenerative medicine 

therapies for serious or life-threatening 

diseases or conditions with FDA’s 

recommendations on the expedited 

development and review of these 

therapies. The guidance describes the 

expedited programs available to 

sponsors of regenerative medicine 

therapies for serious or life-threatening 

diseases or conditions, including those 

products designated as regenerative 

advanced therapies (which FDA refers 

to as ‘‘regenerative medicine advanced 

therapy’’ (RMAT) designation). The 

guidance also describes considerations 

in the clinical development of 

regenerative medicine therapies and 

opportunities for sponsors of 

regenerative medicine therapies to 

interact with the Center of Biologics 

Evaluation and Research review staff. 

The guidance documents are available 

on our website at https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents and were issued 

consistent with our good guidance 

practice regulations in 21 CFR 10.115, 

which provide for public comment at 

any time. 

In the Federal Register of November 

18, 2020 (85 FR 73487), we published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Priority Review Designation Requests ................................ 70 1.44 101 30 3,030 

Breakthrough Therapy Designation Requests ..................... 119 1.31 156 70 10,920 

Fast Track Designation Requests ....................................... 205 1.273 261 60 15,660 

RMAT Designation Requests .............................................. 33 1.15 38 60 2,280 

Fast Track Premeeting Packages ....................................... 224 1.75 392 100 39,200 

Total .............................................................................. ........................ ........................ 948 ........................ 71,090 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on a review of the information 

collection since our last request for 

OMB approval, we have increased our 

burden estimates by 389 responses and 

35,325 hours. As reflected in table 1, we 

estimate that 70 respondents will 

submit 101 requests for priority review 

designation annually. We assume an 

average of 30 hours is needed to prepare 

such a request. 

We estimate that 119 respondents will 

submit 156 requests for breakthrough 

designation annually and assume that 

an average of 70 hours is needed to 

prepare such a request. 

We estimate 205 respondents will 

submit 261 requests for fast track 

designation requests annually and 

assume that an average of 60 hours is 

needed to prepare such a request. 

Of the requests for fast track 

designation made per year, we granted 

approximately 224 requests from 392 

respondents, and for each of these 

granted requests, a premeeting package 

was submitted. We therefore assume an 

average burden of 100 hours per 

respondent for preparing a premeeting 

package. 

Finally, we estimate 33 respondents 

will submit 38 requests for RMAT 

designation and assume that an average 

of 60 hours is needed to prepare such 

a request. 


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Federal Register / Vol. 86, No. 31 / Thursday, February 18, 2021 / Notices 10097 

Dated: February 10, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–03244 Filed 2–17–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0165] 

International Drug Scheduling; 

Convention on Psychotropic 

Substances; Single Convention on 

Narcotic Drugs; World Health 

Organization; Scheduling 

Recommendations; Isotonitazene; 

MDMB-4en-PINACA; CUMYLPEGACLONE; Flubromazolam; 

Clonazolam; Diclazepam; 3- 

Methoxyphencyclidine; Diphenidine; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is providing 

interested persons with the opportunity 

to submit written comments concerning 

recommendations by the World Health 

Organization (WHO) to impose 

international manufacturing and 

distributing restrictions, under 

international treaties, on certain drug 

substances. The comments received in 

response to this notice will be 

considered in preparing the United 

States’ position on these proposals for a 

meeting of the United Nations 

Commission on Narcotic Drugs (CND) in 

Vienna, Austria, in April 2021. This 

notice is issued under the Controlled 

Substances Act (CSA). 

DATES: Submit either electronic or 

written comments by March 22, 2021. 

ADDRESSES: You may submit comments 

as follows: 

Electronic Submissions 

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– 

2021–N–0165 for ‘‘International Drug 

Scheduling; Convention on 

Psychotropic Substances; Single 

Convention on Narcotic Drugs; World 

Health Organization; Scheduling 

Recommendations; Isotonitazene; 

MDMB-4en-PINACA; CUMYLPEGACLONE; Flubromazolam; 

Clonazolam; Diclazepam; 3- 

Methoxyphencyclidine; Diphenidine; 

Request for Comments.’’ 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. 

FOR FURTHER INFORMATION CONTACT: 

James R. Hunter, Center for Drug 

Evaluation and Research, Controlled 

Substance Staff, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 5150, Silver Spring, 

MD 20993–0002, 301–796–3156, 

james.hunter@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The United States is a party to the 

1971 Convention on Psychotropic 

Substances (1971 Convention). Section 

201(d)(2)(B) of the CSA (21 U.S.C. 

811(d)(2)(B)) provides that when the 

United States is notified under Article 2 

of the 1971 Convention that the CND 

proposes to decide whether to add a 

drug or other substance to one of the 

schedules of the 1971 Convention, 

transfer a drug or substance from one 

schedule to another, or delete it from 

the schedules, the Secretary of State 

must transmit notice of such 

information to the Secretary of Health 

and Human Services (Secretary of HHS). 

The Secretary of HHS must then publish 

a summary of such information in the 

Federal Register and provide 

opportunity for interested persons to 

submit comments. The Secretary of HHS 

must then evaluate the proposal and 

furnish a recommendation to the 

Secretary of State that shall be binding 

on the representative of the United 

States in discussions and negotiations 

relating to the proposal. 


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