Arthritis Advisory Committee: Notice of Postponement of Meeting, 12823 [2015-05527]
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Federal Register / Vol. 80, No. 47 / Wednesday, March 11, 2015 / Notices
Rmajette on DSK2VPTVN1PROD with NOTICES
updated in accordance with the Meeting
Management Goals section of the
PDUFA Reauthorization Performance
Goals and Procedures, Fiscal Years 2013
through 2017. Significant changes from
the 2009 guidance include:
• Addition of the written response
meeting format for pre-investigational
new drug application and Type C
meetings
• Designation of a post-action meeting
requested within 3 months after an
FDA regulatory action other than
approval as a Type A meeting
• Designation of a post-action meeting
requested 3 or more months after an
FDA regulatory action other than
approval as a Type B meeting
• Designation of a meeting regarding
risk evaluation and mitigation
strategies or postmarketing
requirements that occur outside the
context of the review of a marketing
application as a Type B meeting
• Inclusion of a meeting package in
Type A meeting requests
• Designation of meetings to discuss the
overall development program for
products granted breakthrough
therapy designation status as a Type
B meeting
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on formal meetings between FDA and
sponsors or applicants of PDUFA
products. It does not create or confer
any rights for or on any person and does
not operate to bind FDA or the public.
An alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. The Paperwork Reduction Act of
1995
This draft guidance refers to
previously approved collections of
information that are subject to review by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520). The
collections of information referred to in
the guidance entitled ‘‘Formal Meetings
Between the FDA and Sponsors or
Applicants’’ have been approved under
OMB control number 0910–0429. The
collections of information for Form FDA
1571 and end-of-phase 2 meetings have
been approved under OMB control
number 0910–0014, and collections of
information for Form FDA 356h have
VerDate Sep<11>2014
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been approved under OMB control
number 0910–0338.
III. Comments
Interested persons may submit either
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or written comments to the Division of
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IV. Electronic Access
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regulations.gov.
Dated: March 5, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–05523 Filed 3–10–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
Arthritis Advisory Committee: Notice
of Postponement of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is postponing the
meeting of the Arthritis Advisory
Committee scheduled for March 17,
2015. The meeting was announced in
the Federal Register of February 10,
2015 (80 FR 7480). The postponement is
due to information requests pending
with the sponsor of the application. A
future meeting date will be announced
in the Federal Register.
FOR FURTHER INFORMATION CONTACT:
Stephanie L. Begansky, Center for Drug
Evaluation and Research, Food and
SUMMARY:
PO 00000
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12823
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, FAX: 301–847–8533, email:
AAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). Please call the
Information Line for up-to-date
information on this meeting.
Dated: March 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–05527 Filed 3–10–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Temporary Assistance for Needy
Families Two-Parent Study.
OMB No.: New Collection.
Description: The Administration for
Children and Families (ACF) is
proposing an information collection
activity as part of the Temporary
Assistance for Needy Families TwoParent Study. Through this information
collection, ACF seeks to gain an indepth, systematic understanding of the
characteristics of two-parent families
participating in or eligible to receive
TANF, the variety of services two-parent
families receive through TANF, how
state policies may affect participation in
TANF among two-parent families, and
how the beliefs of staff and eligible
families affect two-parent families’
participation in TANF.
The proposed information collection
consists of semi-structured interviews
with key State and local staff,
community-based organization
representatives, and adult members of
two-parent TANF or likely eligible
families on questions of TANF policies,
service delivery, and program context,
as well as focus groups with adult
members of two-parent TANF or likely
eligible families.
Respondents: State- and local-level
TANF administrators and staff,
representatives from community-based
organizations, and adults from twoparent families on or likely eligible for
TANF.
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]]>Agencies
[Federal Register Volume 80, Number 47 (Wednesday, March 11, 2015)]
[Notices]
[Page 12823]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-05527]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0001]
Arthritis Advisory Committee: Notice of Postponement of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is postponing the
meeting of the Arthritis Advisory Committee scheduled for March 17,
2015. The meeting was announced in the Federal Register of February 10,
2015 (80 FR 7480). The postponement is due to information requests
pending with the sponsor of the application. A future meeting date will
be announced in the Federal Register.
FOR FURTHER INFORMATION CONTACT: Stephanie L. Begansky, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, FAX: 301-847-8533, email: AAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area). Please call the Information Line for up-to-date
information on this meeting.
Dated: March 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05527 Filed 3-10-15; 8:45 am]
BILLING CODE 4164-01-P
