Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry, Researchers, Patient Groups, and FDA Staff on Meetings With the Office of Orphan Products Development, 31602 [2015-13472]

Download as PDF 31602 Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Notices number. OMB has now approved the information collection and has assigned OMB control number 0910–0785. The approval expires on May 31, 2018. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. Dated: May 29, 2015. Leslie Kux, Associate Commissioner for Policy. the Internet at https://www.reginfo.gov/ public/do/PRAMain. Dated: May 29, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–13472 Filed 6–2–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2015–13473 Filed 6–2–15; 8:45 am] Food and Drug Administration BILLING CODE 4164–01–P [Docket No. FDA–2012–N–0882] DEPARTMENT OF HEALTH AND HUMAN SERVICES Generic Drug User Fees; Stakeholder Meetings on Generic Drug User Fee Amendments of 2012 Reauthorization; Request for Notification of Stakeholder Intention To Participate Food and Drug Administration [Docket No. FDA–2014–D–0313] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry, Researchers, Patient Groups, and FDA Staff on Meetings With the Office of Orphan Products Development AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ‘‘Guidance for Industry, Researchers, Patient Groups, and FDA Staff on Meetings with the Office of Orphan Products Development’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: On March 4, 2015, the Agency submitted a proposed collection of information entitled, ‘‘Guidance for Industry, Researchers, Patient Groups, and FDA Staff on Meetings with the Office of Orphan Products Development’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0787. The approval expires on May 31, 2018. A copy of the supporting statement for this information collection is available on tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:57 Jun 02, 2015 Jkt 235001 AGENCY: Food and Drug Administration, HHS. Notice; request for notification of participation. ACTION: The Food and Drug Administration (FDA) is issuing this notice to request that public stakeholders, including patient and consumer advocacy groups, health care professionals, and scientific and academic experts, notify FDA of their intent to participate in periodic consultation meetings on the reauthorization of the Generic Drug User Fee Amendments of 2012 (GDUFA). The statutory authority for GDUFA expires at the end of September 2017. At that time, new legislation will be required for FDA to continue collecting user fees for the generic drug program. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA consult with a range of stakeholders in developing recommendations for the next GDUFA program. The FD&C Act also requires that FDA hold continued discussions with patient and consumer advocacy groups at least monthly during FDA’s negotiations with the regulated industry. The purpose of this request for notification is to ensure continuity and progress in these monthly discussions by establishing consistent stakeholder representation. SUMMARY: Submit notification of intention to participate by August 14, 2015. ADDRESSES: Submit notification of intention to participate in monthly stakeholder meetings by email to GenericDrugPolicy@fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: Connie Wisner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1718, DATES: PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 Silver Spring, MD 20993–0002, 240– 402–7946, Connie.Wisner@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Introduction FDA is requesting that public stakeholders, including patient and consumer advocacy groups, health care professionals, and scientific and academic experts, notify the Agency of their intent to participate in periodic consultation meetings on the reauthorization of GDUFA. GDUFA authorizes FDA to collect fees from drug companies that submit marketing applications for certain generic human drug applications, certain drug master files, and certain facilities. GDUFA requires that generic drug manufacturers pay user fees to finance critical and measurable generic drug program enhancements. The statutory authority for GDUFA expires at the end of September 2017. Without new legislation, FDA will no longer be able to collect user fees for future fiscal years to fund the human generic drug review process. Section 744C(d) (21 U.S.C. 379j–43(d)) of the FD&C Act requires that FDA consult with a range of stakeholders in developing recommendations for the next GDUFA program, including representatives from patient and consumer groups, health care professionals, and scientific and academic experts. FDA will initiate this process on June 15, 2015, by holding a public meeting at which stakeholders and other members of the public will be given an opportunity to present their views on reauthorization (80 FR 22204). The FD&C Act further requires that FDA continue meeting with these stakeholders at least once every month during negotiations with the regulated industry to continue discussions of stakeholder views on the reauthorization. FDA is issuing this Federal Register notice to request that stakeholder representatives from patient and consumer groups, health care professional associations, as well as scientific and academic experts notify FDA of their intent to participate in periodic consultation meetings on GDUFA reauthorization. FDA believes that consistent stakeholder representation at these meetings will be important to ensuring progress in these discussions. If you wish to participate in this part of the reauthorization process, please designate one or more representatives from your organization who will commit to attending these meetings and preparing for the discussions as needed. Stakeholders who identify themselves through this E:\FR\FM\03JNN1.SGM 03JNN1

Agencies

[Federal Register Volume 80, Number 106 (Wednesday, June 3, 2015)]
[Notices]
[Page 31602]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-13472]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0313]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Guidance for Industry, Researchers, 
Patient Groups, and FDA Staff on Meetings With the Office of Orphan 
Products Development

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled, ``Guidance for Industry, 
Researchers, Patient Groups, and FDA Staff on Meetings with the Office 
of Orphan Products Development'' has been approved by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: On March 4, 2015, the Agency submitted a 
proposed collection of information entitled, ``Guidance for Industry, 
Researchers, Patient Groups, and FDA Staff on Meetings with the Office 
of Orphan Products Development'' to OMB for review and clearance under 
44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is 
not required to respond to, a collection of information unless it 
displays a currently valid OMB control number. OMB has now approved the 
information collection and has assigned OMB control number 0910-0787. 
The approval expires on May 31, 2018. A copy of the supporting 
statement for this information collection is available on the Internet 
at https://www.reginfo.gov/public/do/PRAMain.

    Dated: May 29, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-13472 Filed 6-2-15; 8:45 am]
BILLING CODE 4164-01-P

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