50362 Federal Register / Vol. 86, No. 171 / Wednesday, September 8, 2021 / Notices 

Assistance Funding authorized by the 

American Rescue Plan Act of 2021. 

DATES: Comments due within 14 days of 

publication. In compliance with the 

requirements of the Paperwork 

Reduction Act of 1995, ACF is soliciting 

public comment on the specific aspects 

of the information collection described 

above and below. 

ADDRESSES: Copies of the proposed 

collection of information can be 

obtained and comments may be 

submitted by emailing infocollection@

acf.hhs.gov. All requests should be 

identified by the title of the information 

collection. 

SUPPLEMENTARY INFORMATION: 

Description: ACF programs require 

detailed financial information from their 

grantees that allows ACF to monitor 

various specialized cost categories 

within each program, to closely manage 

program activities, and to have 

sufficient financial information to 

enable periodic thorough and detailed 

audits. The Generic Clearance for 

Financial Reports used for ACF 

Mandatory Grant Programs allows ACF 

programs to efficiently develop and 

receive approval for financial reports 

that are tailored to specific funding 

recipients and the associated needs of 

the program. For more information 

about the umbrella generic, see: https:// 

www.reginfo.gov/public/do/ 

PRAViewDocument?ref_nbr=202108- 

0970-002. 

This specific GenIC applies to all 

state, territory, and tribal grantees 

awarded TANF Pandemic Emergency 

Assistance Funding as authorized by the 

American Rescue Plan Act of 2021 (Pub. 

L. 117–2). Section 403(c)(6)(A) of the 

Social Security Act was augmented by 

the passage of Public Law 117–2 with 

this opportunity for funding to provide 

non-recurrent, short term benefits and 

associated administrative costs to 

supplement, but not supplant, other 

federal, state, tribal, territorial, or local 

funds in meeting the emergency needs 

of recipients. These federal funds will 

serve as payment for expenditures 

incurred from April 1, 2021, to 

September 30, 2022, and if available, 

any unspent funds will be reallotted and 

available for expenditure for another 12 

months. 

All grantees must complete reporting 

once a year in accordance with Office of 

Family Assistance program policy 

governing the administration of PEAF 

Statute. The accompanying instructions 

and terms and conditions of the grant 

will provide guidance and assist 

grantees with this requirement. 

Respondents: States, Territories, 

Tribes, and Tribal Consortia awarded 

TANF Pandemic Emergency Assistance 

Funding funds authorized by the 

American Rescue Plan Act of 2021. 

ANNUAL BURDEN ESTIMATES

Title of information collection Number of 

respondents 

Annual 

frequency 

of responses 

Hourly 

burden per 

response 

Annual 

hourly 

burden 

ACF–196P ....................................................................................................... 137 1 6 822 

Estimated Total Annual Burden 

Hours: 822. 

Comments: The Department 

specifically requests comments on (a) 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Consideration will be given 

to comments and suggestions submitted 

within 14 days of this publication. 

Authority: Pub. L. 117–2; Section 

403(c)(6)(A) of the American Rescue 

Plan Act of 2021. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2021–19459 Filed 9–7–21; 8:45 am] 

BILLING CODE 4184–56–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–3263] 

Request for Nominations for Voting 

Members on a Public Advisory 

Committee; the Tobacco Products 

Scientific Advisory Committee 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting 

nominations for members to serve on 

the Tobacco Products Scientific 

Advisory Committee, in the Center for 

Tobacco Products. FDA seeks to include 

the views of women and men, members 

of all racial and ethnic groups, and 

individuals with and without 

disabilities on its advisory committees 

and, therefore encourages nominations 

of appropriately qualified candidates 

from these groups. 

DATES: Nominations received on or 

before November 8, 2021 will be given 

first consideration for membership on 

the Tobacco Products Scientific 

Advisory Committee. Nominations 

received after November 8, 2021 will be 

considered for nomination to the 

committee as later vacancies occur. 

ADDRESSES: All nominations for 

membership should be sent 

electronically by logging into the FDA 

Advisory Nomination Portal: https://

www.accessdata.fda.gov/scripts/ 

FACTRSPortal/FACTRS/index.cfm. 

Information about becoming a member 

on an FDA advisory committee can also 

be obtained by visiting FDA’s website 

by using the following link: https://

www.fda.gov/AdvisoryCommittees/ 

default.htm. 

FOR FURTHER INFORMATION CONTACT: 

Regarding all nomination questions for 

membership, the primary contact is: 

Serina Hunter-Thomas, Office of 

Science, Center for Tobacco Products, 

Food and Drug Administration, Center 

for Tobacco Products, Document 

Control Center, Bldg. 71, Rm. G335, 

10903 New Hampshire Ave., Silver 

Spring, MD 20993–0002, 1–877–287– 

1373 (choose Option 5), email: TPSAC@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

requesting nomination for voting 

members on the Tobacco Products 

Scientific Advisory Committee. 


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Federal Register / Vol. 86, No. 171 / Wednesday, September 8, 2021 / Notices 50363 

I. General Description of the Committee 

Duties 

The Tobacco Products Scientific 

Advisory Committee (the Committee) 

advises the Commissioner of FDA (the 

Commissioner) or designee in 

discharging responsibilities related to 

the regulation of tobacco products. The 

Committee reviews and evaluates 

behavior, dependence, and health 

issues, among others, relating to tobacco 

products and provides appropriate 

advice, information, and 

recommendations to the Commissioner. 

II. Criteria for Voting Members 

The Committee shall consist of 12 

members, including the Chair. Members 

and the Chair are selected by the 

Commissioner or designee from among 

individuals knowledgeable in the fields 

of science, medicine, medical ethics, or 

technology involving the manufacture, 

evaluation, or use of tobacco products. 

Almost all non-Federal members of this 

committee serve as Special Government 

Employees. The Committee shall 

include nine technically qualified 

voting members, selected by the 

Commissioner or designee. The nine 

voting members shall be scientists, 

physicians, dentists, or healthcare 

professionals practicing in the areas of 

oncology, pulmonology, cardiology, 

toxicology, pharmacology, addiction, 

epidemiology, behavioral health, or any 

other relevant specialty. One member 

shall be an officer or employee of a state 

or local government or of the Federal 

Government. The final voting member 

shall be a representative of the general 

public. Members will be invited to serve 

for terms of up to 4 years. 

III. Nomination Procedures 

Any interested person may nominate 

one or more qualified individuals for 

membership on the advisory committee. 

Self-nominations are also accepted. 

Nominations must include a current, 

complete re ́sume ́ or curriculum vitae for 

each nominee, including current 

business address and/or home address, 

telephone number, and email address if 

available and a signed copy of the 

Acknowledgement and Consent form 

available at the FDA Advisory 

Nomination Portal (see ADDRESSES). 

Nominations must also specify the 

advisory committee for which the 

nominee is recommended. Nominations 

must also acknowledge that the 

nominee is aware of the nomination 

unless self-nominated. FDA will ask 

potential candidates to provide detailed 

information concerning such matters 

related to financial holdings, 

employment, and research grants and/or 

contracts to permit evaluation of 

possible sources of conflicts of interest. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to advisory committees. 

Dated: September 2, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–19444 Filed 9–7–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–N–5464] 

Center for Drug Evaluation and 

Research Office of New Drugs Novel 

Excipient Review Pilot Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration’s (FDA) Center for Drug 

Evaluation and Research (CDER) is 

announcing a Novel Excipient Review 

Pilot Program (Pilot Program). The Pilot 

Program is voluntary and intended to 

allow excipient manufacturers to obtain 

FDA review of certain novel excipients 

prior to their use in drug formulations. 

The Pilot Program seeks to foster 

development of excipients that may be 

useful in scenarios in which excipient 

manufacturers and drug developers 

have cited difficulty in using existing 

excipients. 

DATES: FDA is seeking initial proposals 

for the voluntary Novel Excipient 

Review Pilot Program through December 

7, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Felecia Wilson, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, Novel-ExcipientProgram@fda.hhs.gov, 301–796–9590. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Excipient manufacturers and drug 

developers have cited product 

development challenges related to the 

use of certain excipients (also known as 

inactive ingredients), including issues 

related to formulation and stability. 

Novel excipients might be able to 

address some of these issues and 

provide additional public health 

benefits, such as enhanced drug 

bioavailability, more comfortable drug 

administration, new abuse-deterrent 

opioid formulations, new routes of drug 

delivery, and facilitation of new 

technologies. However, drug developers 

report that they have been hesitant to 

use novel excipients in drug 

development programs due to the 

uncertainty surrounding their 

acceptability. 

To address these issues, FDA issued 

a request for information in the Federal 

Register on December 5, 2019 (84 FR 

66669), seeking comment on a potential 

pilot program for FDA review of novel 

excipients. FDA received several 

comments to the public docket on these 

issues. After considering these 

comments, CDER has decided to 

establish this Pilot Program. 

A. Scope 

For purposes of the Pilot Program, an 

excipient is any ingredient intentionally 

added to a drug product (including a 

biological drug product) that is not 

intended to exert therapeutic effects at 

the intended dosage, although it may 

improve product delivery (see FDA 

guidance for industry entitled 

‘‘Nonclinical Studies for the Safety 

Evaluation of Pharmaceutical 

Excipients’’ (Ref.1)). Examples of 

excipients may include fillers, 

extenders, diluents, surfactants, 

solvents, emulsifiers, preservatives, 

flavors, absorption enhancers, modified 

release matrices, and coloring agents. 

Also, for purposes of this Pilot Program, 

a novel excipient is any excipient that 

is not fully supported by existing safety 

data with respect to the currently 

proposed level of exposure, duration of 

exposure, or route of administration 

(Ref. 1). This parallels the definition of 

‘‘new excipients’’ defined in Ref. 1. 

CDER proposes a more limited scope 

for this Pilot Program. The Pilot 

Program will initially be available for 

novel excipients that (1) have not been 

previously used in FDA-approved drug 

products, and (2) do not have an 

established use in food. CDER 

recognizes that there may be novel 

excipients not meeting this scope that 

may also address product development 

challenges or provide public health 

benefits. However, because of the 

limited scope of the initial phase of the 

Pilot Program (described further below), 

CDER will not be able to consider 

submissions for all kinds of novel 

excipients. CDER may expand the scope 

of the Pilot Program in the future 

depending on its success and as 

resources allow. 

The Pilot Program is voluntary. 

Existing processes for developing 

excipients for use in drug and biological 

products continue to be available. 


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