87 FR 113 pgs. 35788-35789 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tropical Disease Priority Review Vouchers
Type: NOTICEVolume: 87Number: 113Pages: 35788 - 35789
Pages: 35788, 35789Docket number: [Docket No. FDA-2008-D-0530]
FR document: [FR Doc. 2022-12622 Filed 6-10-22; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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:
| 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 | ||||
| 1 ?There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
[top] 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
Dated: June 6, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-12622 Filed 6-10-22; 8:45 am]
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