80 FR 31602 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 106 (June 3, 2015)

Page Range		31602-31602
FR Document		2015-13472

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.

Federal Register, Volume 80 Issue 106 (Wednesday, June 3, 2015)

[Federal Register Volume 80, Number 106 (Wednesday, June 3, 2015)]
[Notices]
[Page 31602]
From the Federal Register Online  [www.thefederalregister.org]
[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.

-----------------------------------------------------------------------

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, [email protected].

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 http://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

31602 Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Notices

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

currently valid OMB control number. this part of the reauthorization process,
OMB has now approved the information GenericDrugPolicy@fda.hhs.gov. please designate one or more
collection and has assigned OMB FOR FURTHER INFORMATION CONTACT: representatives from your organization
control number 0910–0787. The Connie Wisner, Center for Drug who will commit to attending these
approval expires on May 31, 2018. A Evaluation and Research, Food and meetings and preparing for the
copy of the supporting statement for this Drug Administration, 10903 New discussions as needed. Stakeholders
information collection is available on Hampshire Ave., Bldg. 75, Rm. 1718, who identify themselves through this

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Document Created: 2015-12-15 15:08:53
Document Modified: 2015-12-15 15:08:53

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation		80 FR 31602

80 FR 31602 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 106 (June 3, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration