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Federal Register / Vol. 86, No. 229 / Thursday, December 2, 2021 / Notices
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, 2404027500.
Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A12M, 11601
Landsdown St., North Bethesda, MD
20852, 3017967726, PRAStaff@
fda.hhs.gov.

FOR FURTHER INFORMATION CONTACT:

Under the PRA 44 U.S.C. 35013521, Federal Agencies must obtain approval from the Office of Management and Budget OMB for each collection of information they conduct or sponsor.
Collection of information is defined in 44 U.S.C. 35023 and 5 CFR
1320.3c and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party.
Section 3506c2A of the PRA 44
U.S.C. 3506c2A requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB
for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

SUPPLEMENTARY INFORMATION:

With respect to the following collection of information, FDA invites comments on these topics: 1 Whether the proposed collection of information is necessary for the proper performance of FDAs functions, including whether the information will have practical utility; 2 the accuracy of FDAs estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; 3 ways to enhance the quality, utility, and clarity of the information to be collected; and 4
ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
Tropical Disease Priority Review Vouchers OMB Control Number 09100822
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
524a3 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 524a4, may be eligible for a voucher that can be used to obtain a priority review for any other application submitted under section 505b1 of the FD&C Act 21 U.S.C. 355b1 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 505b1 of the FD&C Act or section 351
of the PHS Act.
We estimate the burden of this collection of information as follows:

TABLE 1ESTIMATED ANNUAL REPORTING BURDEN 1
Average burden per response
Total annual responses
Total hours
Priority Review Voucher Request
Notifications of Intent to Use a Voucher
Letters Indicating the Transfer of a Voucher Letter
Acknowledging the Receipt of a Transferred Voucher
Attestation of eligibility

4
2 2
2 4

1
1 1
1 1

4
2 2
2 4

8
8 8
8 2

32
16
16
16
8

Total

88

1 There
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.
lotter on DSK11XQN23PROD with NOTICES1

Number of responses per respondent
Number of respondents
Information collection activity
Dated: November 24, 2021.
Lauren K. Roth, Associate Commissioner for Policy.
FR Doc. 202126196 Filed 12121; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2021N1222

Agency Information Collection Activities; Proposed Collection;
Comment Request; Food Labeling:
Notification Procedures for Statements on Dietary Supplements AGENCY:

Food and Drug Administration,
HHS.

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ACTION:

Notice.

The Food and Drug Administration FDA, Agency, or we is announcing an opportunity for public comment on the proposed collection of certain information by the Agency.
Under the Paperwork Reduction Act of 1995 PRA, Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and
SUMMARY:

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