80_FR_72290 80 FR 72068 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Tropical Disease Priority Review Vouchers

80 FR 72068 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Tropical Disease Priority Review Vouchers

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 222 (November 18, 2015)

Page Range72068-72069
FR Document2015-29406

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 (the PRA).

Federal Register, Volume 80 Issue 222 (Wednesday, November 18, 2015) 
[Federal Register Volume 80, Number 222 (Wednesday, November 18, 2015)]
[Notices]
[Pages 72068-72069]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-29406]


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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; Guidance for Industry 
on Tropical Disease Priority Review Vouchers

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 (the PRA).

DATES: Fax written comments on the collection of information by 
December 18, 2015.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-New and 
title ``Guidance for Industry on Tropical Disease Priority Review 
Vouchers.'' Also include the FDA docket number found in brackets in the 
heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

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.

Guidance for Industry on Tropical Disease Priority Review Vouchers--OMB 
Control Number 0910-NEW

    Section 1102 of the Food and Drug Administration Amendments Act 
(FDAAA) adds new section 524 to the Federal Food, Drug, and Cosmetic 
Act (the FD&C Act) (21 U.S.C. 360n). Section 524 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. By enacting section 524, Congress intended to stimulate new 
drug development for drugs to treat certain tropical diseases for which 
there are no or few available treatments by offering additional 
incentives for obtaining FDA approval for pharmaceutical treatments for 
these diseases. Under section 524, a sponsor of a human drug 
application for a

[[Page 72069]]

qualified tropical disease may be eligible for a voucher that can be 
used to obtain a priority review for any 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 (the PHS Act). The guidance explains 
to internal and external stakeholders how FDA intends to implement the 
provisions of section 524, and provides information on using the 
priority review vouchers and on transferring priority review vouchers 
to other sponsors.
    Under the guidance, sponsors of certain tropical disease drug 
product applications submitted under section 505(b)(1) of the FD&C Act 
and section 351 of the PHS Act may request a priority review voucher. 
Based on inquiries and discussions with industry about section 524, we 
estimate that we will receive annually approximately five requests from 
five sponsors, and that each request will take approximately 8 hours to 
prepare and submit to FDA.
    The guidance also states that sponsors should notify FDA of their 
intent to use a priority review voucher, including the date on which 
the sponsor intends to submit the application, at least 90 days before 
use. We estimate that we will receive annually approximately five 
notifications of intent to use a voucher from five sponsors, and that 
each notification will take approximately 8 hours to prepare and submit 
to FDA.
    The guidance also permits the transfer of a priority review voucher 
from one sponsor to another, and states that each transfer should be 
documented with a letter of transfer. We estimate that we will receive 
approximately two letters indicating the transfer of a voucher from two 
application holders, and two letters from two new voucher owners 
acknowledging the transfer, and that it will take approximately 8 hours 
to prepare and submit each letter to FDA.
    In the Federal Register of October 20, 2008 (73 FR 62298), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. The comments we received did not pertain to 
the information collection that would result from the guidance (that 
is, the four types of submissions estimated in table 1).
    FDA estimates the burden of this collection of information as 
follows:
    Description of Respondents: Sponsors submitting applications under 
section 505(b)(1) of the FD&C Act or section 351 of the PHS Act.

                                 Table 1--Estimated Annual Reporting Burden \1\
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    Guidance for Industry on                         Number of
Tropical Disease Priority Review     Number of     responses per   Total annual   Average burden    Total hours
            Vouchers                respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Priority Review Voucher Request.               5               1               5               8              40
Notifications of Intent To Use a               5               1               5               8              40
 Voucher........................
Letters Indicating the Transfer                2               1               2               8              16
 of a Voucher Letter............
Acknowledging the Receipt of a                 2               1               2               8              16
 Transferred Voucher............
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             112
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: November 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-29406 Filed 11-17-15; 8:45 am]
BILLING CODE 4164-01-P

72068 Federal Register / Vol. 80, No. 222 / Wednesday, November 18, 2015 / Notices continue to include a notice of denial or withdrawal of approval of a following is a list of approved PMAs for opportunity to request review of the PMA may be sought only by the which summaries of safety and order under section 515(g) of the FD&C applicant; in these cases, the 30-day effectiveness were placed on the Act. The 30-day period for requesting period will begin when the applicant is Internet from July 1, 2015, through reconsideration of an FDA action under notified by FDA in writing of its September 30, 2015. There were no § 10.33(b) (21 CFR 10.33(b)) for notices decision. denial actions during this period. The announcing approval of a PMA begins The regulations provide that FDA list provides the manufacturer’s name, on the day the notice is placed on the publish a quarterly list of available the product’s generic name or the trade Internet. Section 10.33(b) provides that safety and effectiveness summaries of name, and the approval date. FDA may, for good cause, extend this PMA approvals and denials that were 30-day period. Reconsideration of a announced during that quarter. The TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JULY 1, 2015, THROUGH SEPTEMBER 30, 2015 Approval PMA No., docket No. Applicant Trade name date P930016/S044, FDA–2015–M–1707 ........ AMO Manufacturing USA, LLC ................ STAR S4 IR Exciter Laser System and 5/6/2015 iDesign WaveScan Studio System. P120024, FDA–2015–M–2218 ................. Aesculap Implant Systems, LLC .............. activL® Artificial Disc ................................ 6/11/2015 P140021, FDA–2015–M–2217 ................. Roche Diagnostics Operations, Inc .......... Elecsys® Anti-HCV II Immunoassay and 6/11/2015 Elecsys® PreciControl Anti-HCV. P140009, FDA–2015–M–2497 ................. St. Jude Medical Neuromodulation .......... Brio Neurostimulation System .................. 6/12/2015 P140025, FDA–2015–M–2219 ................. Ventana Medical Systems, Inc ................. VENTANA ALK (D5F3) CDx Assay ......... 6/12/2015 P140031, FDA–2015–M–2499 ................. Edwards Lifesciences, LLC ...................... SAPIEN 3TM Transcatheter Heart Valve 6/17/2015 and Accessories. P040024/S073, FDA–2015–M–2634 ........ Galderma Laboratories L.P. ..................... Restylane Lyft with Lidocaine ................... 7/1/2015 H080004, FDA–2015–M–2584 ................. Integrum AB .............................................. Osseoanchored Prostheses for the Reha- 7/16/2015 bilitation of Amputees (OPRA). P140028, FDA–2015–M–2618 ................. Boston Scientific Corporation ................... InnovaTM Vascular Self-Expanding Stent 7/21/2015 System. P140013, FDA–2015–M–2739 ................. Minerva Surgical, Inc ................................ MinervaTM Endometrial Ablation System. 7/27/2015 P140012, FDA–2015–M–2740 ................. ReShape Medical, Inc .............................. ReShape Integrated Dual Balloon Sys- 7/28/2015 tem. P140008, FDA–2015–M–2964 ................. Apollo Endosurgery, Inc ........................... ORBERATM Intragastric Balloon System. 8/5/2015 II. Electronic Access SUMMARY: The Food and Drug SUPPLEMENTARY INFORMATION: In Administration (FDA) is announcing compliance with 44 U.S.C. 3507, FDA Persons with access to the Internet that a proposed collection of has submitted the following proposed may obtain the documents at http:// information has been submitted to the collection of information to OMB for www.fda.gov/MedicalDevices/ Office of Management and Budget review and clearance. ProductsandMedicalProcedures/ (OMB) for review and clearance under DeviceApprovalsandClearances/ Guidance for Industry on Tropical the Paperwork Reduction Act of 1995 PMAApprovals/default.htm. Disease Priority Review Vouchers— (the PRA). Dated: November 13, 2015. OMB Control Number 0910–NEW DATES: Fax written comments on the Leslie Kux, collection of information by December Section 1102 of the Food and Drug Associate Commissioner for Policy. 18, 2015. Administration Amendments Act [FR Doc. 2015–29450 Filed 11–17–15; 8:45 am] ADDRESSES: To ensure that comments on (FDAAA) adds new section 524 to the BILLING CODE 4164–01–P the information collection are received, Federal Food, Drug, and Cosmetic Act OMB recommends that written (the FD&C Act) (21 U.S.C. 360n). comments be faxed to the Office of Section 524 is designed to encourage DEPARTMENT OF HEALTH AND Information and Regulatory Affairs, development of new drug or biological HUMAN SERVICES OMB, Attn: FDA Desk Officer, FAX: products for prevention and treatment 202–395–7285, or emailed to oira_ of certain tropical diseases affecting Food and Drug Administration submission@omb.eop.gov. All millions of people throughout the world comments should be identified with the and makes provisions for awarding [Docket No. FDA–2008–D–0530] OMB control number 0910-New and priority review vouchers for future title ‘‘Guidance for Industry on Tropical applications to sponsors of tropical Agency Information Collection Disease Priority Review Vouchers.’’ disease products. By enacting section Activities; Submission for Office of Also include the FDA docket number 524, Congress intended to stimulate new asabaliauskas on DSK5VPTVN1PROD with NOTICES Management and Budget Review; found in brackets in the heading of this drug development for drugs to treat Comment Request; Guidance for document. certain tropical diseases for which there Industry on Tropical Disease Priority FOR FURTHER INFORMATION CONTACT: FDA are no or few available treatments by Review Vouchers PRA Staff, Office of Operations, Food offering additional incentives for AGENCY: Food and Drug Administration, and Drug Administration, 8455 obtaining FDA approval for HHS. Colesville Rd., COLE–14526, Silver pharmaceutical treatments for these Spring, MD 20993–0002, PRAStaff@ diseases. Under section 524, a sponsor ACTION: Notice. fda.hhs.gov. of a human drug application for a VerDate Sep<11>2014 20:14 Nov 17, 2015 Jkt 238001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\FR\FM\18NON1.SGM 18NON1

Federal Register / Vol. 80, No. 222 / Wednesday, November 18, 2015 / Notices 72069 qualified tropical disease may be about section 524, we estimate that we indicating the transfer of a voucher from eligible for a voucher that can be used will receive annually approximately five two application holders, and two letters to obtain a priority review for any requests from five sponsors, and that from two new voucher owners application submitted under section each request will take approximately 8 acknowledging the transfer, and that it 505(b)(1) of the FD&C Act (21 U.S.C. hours to prepare and submit to FDA. will take approximately 8 hours to 355(b)(1)) or section 351 of the Public The guidance also states that sponsors prepare and submit each letter to FDA. Health Service Act (the PHS Act). The should notify FDA of their intent to use In the Federal Register of October 20, guidance explains to internal and a priority review voucher, including the 2008 (73 FR 62298), FDA published a external stakeholders how FDA intends date on which the sponsor intends to 60-day notice requesting public to implement the provisions of section submit the application, at least 90 days comment on the proposed collection of 524, and provides information on using before use. We estimate that we will information. The comments we received the priority review vouchers and on receive annually approximately five did not pertain to the information transferring priority review vouchers to notifications of intent to use a voucher collection that would result from the from five sponsors, and that each guidance (that is, the four types of other sponsors. notification will take approximately 8 submissions estimated in table 1). Under the guidance, sponsors of hours to prepare and submit to FDA. certain tropical disease drug product The guidance also permits the transfer FDA estimates the burden of this applications submitted under section of a priority review voucher from one collection of information as follows: 505(b)(1) of the FD&C Act and section sponsor to another, and states that each Description of Respondents: Sponsors 351 of the PHS Act may request a transfer should be documented with a submitting applications under section priority review voucher. Based on letter of transfer. We estimate that we 505(b)(1) of the FD&C Act or section 351 inquiries and discussions with industry will receive approximately two letters of the PHS Act. TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of Average Guidance for Industry on Tropical Disease Priority Review Number of Total annual responses per burden per Total hours Vouchers respondents responses respondent response Priority Review Voucher Request ........................................ 5 1 5 8 40 Notifications of Intent To Use a Voucher ............................ 5 1 5 8 40 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 Total .............................................................................. ........................ ........................ ........................ ........................ 112 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: November 12, 2015. applicants relating to the development confidential information that you or a Leslie Kux, and review of biosimilar biological third party may not wish to be posted, Associate Commissioner for Policy. products regulated by the Center for such as medical information, your or [FR Doc. 2015–29406 Filed 11–17–15; 8:45 am] Drug Evaluation and Research (CDER) anyone else’s Social Security number, or BILLING CODE 4164–01–P and the Center for Biologics Evaluation confidential business information, such and Research (CBER). The guidance as a manufacturing process. Please note assists sponsors and applicants in that if you include your name, contact DEPARTMENT OF HEALTH AND generating and submitting meeting information, or other information that HUMAN SERVICES requests and the associated meeting identifies you in the body of your packages to FDA for biosimilar comments, that information will be Food and Drug Administration biological products. This guidance posted on http://www.regulations.gov. finalizes the draft guidance issued on • If you want to submit a comment [Docket No. FDA–2013–D–0286] April 1, 2013. with confidential information that you Formal Meetings Between the Food DATES: Submit either electronic or do not wish to be made available to the and Drug Administration and written comments on Agency guidances public, submit the comment as a Biosimilar Biological Product at any time. written/paper submission and in the Sponsors or Applicants; Guidance for ADDRESSES: You may submit comments manner detailed (see ‘‘Written/Paper Industry; Availability as follows: Submissions’’ and ‘‘Instructions’’). AGENCY: Food and Drug Administration, Electronic Submissions Written/Paper Submissions HHS. Submit electronic comments in the Submit written/paper submissions as ACTION: Notice of availability. following way: follows: • Federal eRulemaking Portal: http:// • Mail/Hand delivery/Courier (for SUMMARY: The Food and Drug www.regulations.gov. Follow the written/paper submissions): Division of asabaliauskas on DSK5VPTVN1PROD with NOTICES Administration (FDA or Agency) is instructions for submitting comments. Dockets Management (HFA–305), Food announcing the availability of a Comments submitted electronically, and Drug Administration, 5630 Fishers guidance for industry entitled ‘‘Formal including attachments, to http:// Lane, rm. 1061, Rockville, MD 20852. Meetings Between the FDA and www.regulations.gov will be posted to • For written/paper comments Biosimilar Biological Product Sponsors the docket unchanged. Because your submitted to the Division of Dockets or Applicants.’’ This guidance provides comment will be made public, you are Management, FDA will post your recommendations to industry on formal solely responsible for ensuring that your comment, as well as any attachments, meetings between FDA and sponsors or comment does not include any except for information submitted, VerDate Sep<11>2014 18:50 Nov 17, 2015 Jkt 238001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\FR\FM\18NON1.SGM 18NON1


Document Created: 2018-03-01 11:20:22
Document Modified: 2018-03-01 11:20:22
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesFax written comments on the collection of information by December 18, 2015.
ContactFDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation80 FR 72068 
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