35788 Federal Register / Vol. 87, No. 113 / Monday, June 13, 2022 / Notices 

Further information regarding the 

most recent charter and other 

information can be found at https://

www.fda.gov/advisory-committees/ 

toxicological-research-science-advisoryboard-national-center-toxicologicalresearch/charter-science-advisoryboard-national-center-toxicologicalresearch or by contacting the Designated 

Federal Officer (see FOR FURTHER

INFORMATION CONTACT). In light of the 

fact that no change has been made to the 

committee name or description of 

duties, no amendment will be made to 

21 CFR 14.100. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app.). For general information 

related to FDA advisory committees, 

please visit us at http://www.fda.gov/ 

AdvisoryCommittees/default.htm. 

Dated: June 3, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–12655 Filed 6–10–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0530] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Tropical Disease 

Priority Review Vouchers 

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 July 13, 

2022. 

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 0910–0822. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–769–8867, 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. 

Tropical Disease Priority Review 

Vouchers 

OMB Control Number 0910–0822— 

Extension 

Section 524 of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) (21 U.S.C. 

360n) is designed to encourage 

development of new drug or biological 

products for prevention and treatment 

of certain tropical diseases affecting 

millions of people throughout the world 

and makes provisions for awarding 

priority review vouchers for future 

applications to sponsors of tropical 

disease products. Section 524 of the 

FD&C Act serves to stimulate new drug 

development for drugs to treat a 

‘‘tropical disease’’ (as defined in section 

524(a)(3)) by offering additional 

incentives for obtaining FDA approval 

for pharmaceutical treatments for these 

diseases. Under section 524 of the FD&C 

Act, a sponsor of a ‘‘tropical disease 

product application,’’ as defined in 

section 524(a)(4), may be eligible for a 

voucher that can be used to obtain a 

priority review for any other application 

submitted under section 505(b)(1) of the 

FD&C Act (21 U.S.C. 355(b)(1)) or 

section 351 of the Public Health Service 

Act (PHS Act). 

Accordingly, we have developed the 

guidance for industry entitled ‘‘Tropical 

Disease Priority Review Vouchers’’ 

(available at https://www.fda.gov/ 

media/72569/download). The guidance 

explains how FDA implements 

provisions of section 524 of the FD&C 

Act and how sponsors may qualify for 

a priority review voucher based on 

eligibility criteria set forth in the statute, 

how to use priority review vouchers, 

and how priority review vouchers may 

be transferred to other sponsors. 

The guidance also communicates that, 

under the FDA Reauthorization Act of 

2017, section 524 requires attestation by 

the sponsor of eligibility for a priority 

review voucher upon submission of the 

marketing application. 

Description of Respondents: Sponsors 

submitting applications under section 

505(b)(1) of the FD&C Act or section 351 

of the PHS Act. 

In the Federal Register of December 2, 

2021 (86 FR 68503), FDA 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

Information collection activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Priority Review Voucher Request ........................................ 4 1 4 8 32 

Notifications of Intent to Use a Voucher .............................. 2 1 2 8 16 

Letters Indicating the Transfer of a Voucher Letter ............ 2 1 2 8 16 

Acknowledging the Receipt of a Transferred Voucher ........ 2 1 2 8 16 

Attestation of eligibility ......................................................... 4 1 4 2 8 

Total .............................................................................. ........................ ........................ ........................ ........................ 88 

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

Based on our evaluation of the 

information collection since last OMB 

review and approval, the burden 

estimate decreased based on receipt of 

fewer vouchers and other information 

collection activities. Our estimated 

burden for the information collection 

reflects an overall decrease of 34 hours 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 113 / Monday, June 13, 2022 / Notices 35789 

and a corresponding decrease of 5 

responses. 

Dated: June 6, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–12622 Filed 6–10–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–1222] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Food Labeling: 

Notification Procedures for Statements 

on Dietary Supplements 

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 July 13, 

2022. 

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 0910–0331. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, 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. 

Food Labeling: Notification Procedures 

for Statements on Dietary 

Supplements—21 CFR 101.93 

OMB Control Number 0910–0331— 

Extension 

Section 403(r)(6) (21 U.S.C. 343(r)(6)) 

of the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) and § 101.93 (21 CFR 

101.93) require that, no later than 30 

days after the first marketing, we be 

notified by the manufacturer, packer, or 

distributor of a dietary supplement that 

it is marketing a dietary supplement 

product that bears on its label or in its 

labeling a statement provided for in 

section 403(r)(6) of the FD&C Act. In 

accordance with these requirements, 

submissions must include: (1) the name 

and address of the manufacturer, 

packer, or distributor of the dietary 

supplement product; (2) the text of the 

statement that is being made; (3) the 

name of the dietary ingredient or 

supplement that is the subject of the 

statement; (4) the name of the dietary 

supplement (including the brand name); 

and (5) the signature of a responsible 

individual or the person who can certify 

the accuracy of the information 

presented, and who must certify that the 

information contained in the notice is 

complete and accurate, and that the 

notifying firm has substantiation that 

the statement is truthful and not 

misleading. 

Our electronic form (Form FDA 3955) 

allows respondents to the information 

collection to electronically submit 

notifications to FDA via the Food 

Applications Regulatory Management 

(FARM) system. Firms that prefer to 

submit a paper notification in a format 

of their own choosing will still have the 

option to do so; however, Form FDA 

3955 prompts respondents to include 

certain elements in their structure/ 

function claim notification (SFCN) 

described in § 101.93 in a standard 

electronic format and helps respondents 

organize their SFCN to include only the 

information needed for our review of 

the claim. Note that the SFCN, whether 

electronic or paper, is used for all 

claims made pursuant to section 

403(r)(6) of the FD&C Act, including 

nutrient deficiency claims and general 

well-being claims in addition to 

structure/function claims. The 

electronic form, and any optional 

elements prepared as attachments to the 

form (e.g., label), can be submitted in 

electronic format via FARM. 

Submissions of SFCNs will continue to 

be allowed in paper format. We use this 

information to evaluate whether 

statements made for dietary ingredients 

or dietary supplements are permissible 

under section 403(r)(6) of the FD&C Act. 

Description of Respondents: 

Respondents to this collection of 

information include manufacturers, 

packers, or distributors of dietary 

supplements that bear section 403(r)(6) 

of the FD&C Act statements on their 

labels or labeling. 

In the Federal Register of December 2, 

2021 (86 FR 68504), FDA 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

21 CFR section; activity; form No. Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total 

hours 

101.93; Statements for Dietary Supplements; Form FDA 3955 .............. 3,690 1 3,690 0.75 (45 minutes) ....... 2,768 

1 There 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 made no 

adjustments to our burden estimate. 

This estimate is based on our experience 

with this information collection and the 

number of notifications received in the 

past 3 years, which has remained 

constant. 

Dated: June 6, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–12625 Filed 6–10–22; 8:45 am] 

BILLING CODE 4164–01–P 


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