80 FR 12823 - Arthritis Advisory Committee: Notice of Postponement of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 47 (March 11, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 47 (March 11, 2015)
| Page Range | 12823-12823 | |
| FR Document | 2015-05527 |
[Federal Register Volume 80, Number 47 (Wednesday, March 11, 2015)] [Notices] [Page 12823] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-05527] ----------------------------------------------------------------------- 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: [email protected], 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
![Federal Register / Vol. 80, No. 47 / Wednesday, March 11, 2015 / Notices 12823
updated in accordance with the Meeting been approved under OMB control Drug Administration, 10903 New
Management Goals section of the number 0910–0338. Hampshire Ave., Bldg. 31, Rm. 2417,
PDUFA Reauthorization Performance Silver Spring, MD 20993–0002, 301–
III. Comments
Goals and Procedures, Fiscal Years 2013 796–9001, FAX: 301–847–8533, email:
through 2017. Significant changes from Interested persons may submit either AAC@fda.hhs.gov, or FDA Advisory
the 2009 guidance include: electronic comments regarding this Committee Information Line, 1–800–
• Addition of the written response document to http://www.regulations.gov 741–8138 (301–443–0572 in the
meeting format for pre-investigational or written comments to the Division of Washington, DC area). Please call the
new drug application and Type C Dockets Management (see ADDRESSES). It Information Line for up-to-date
meetings is only necessary to send one set of information on this meeting.
• Designation of a post-action meeting comments. Identify comments with the
Dated: March 6, 2015.
requested within 3 months after an docket number found in brackets in the
Leslie Kux,
FDA regulatory action other than heading of this document. Received
comments may be seen in the Division Associate Commissioner for Policy.
approval as a Type A meeting
• Designation of a post-action meeting of Dockets Management between 9 a.m. [FR Doc. 2015–05527 Filed 3–10–15; 8:45 am]
requested 3 or more months after an and 4 p.m., Monday through Friday, and BILLING CODE 4164–01–P
FDA regulatory action other than will be posted to the docket at http://
approval as a Type B meeting www.regulations.gov.
• Designation of a meeting regarding DEPARTMENT OF HEALTH AND
IV. Electronic Access HUMAN SERVICES
risk evaluation and mitigation
strategies or postmarketing Persons with access to the Internet
may obtain the document at http:// Administration for Children and
requirements that occur outside the
www.fda.gov/Drugs/ Families
context of the review of a marketing
application as a Type B meeting GuidanceComplianceRegulatory
Submission for OMB Review;
• Inclusion of a meeting package in Information/Guidances/default.htm,
Comment Request
Type A meeting requests http://www.fda.gov/BiologicsBlood
• Designation of meetings to discuss the Vaccines/Guidance Title: Temporary Assistance for Needy
overall development program for ComplianceRegulatoryInformation/ Families Two-Parent Study.
products granted breakthrough default.htm, or http://www.
OMB No.: New Collection.
therapy designation status as a Type regulations.gov.
B meeting Description: The Administration for
Dated: March 5, 2015. Children and Families (ACF) is
This draft guidance is being issued Leslie Kux, proposing an information collection
consistent with FDA’s good guidance Associate Commissioner for Policy. activity as part of the Temporary
practices regulation (21 CFR 10.115). [FR Doc. 2015–05523 Filed 3–10–15; 8:45 am] Assistance for Needy Families Two-
The draft guidance, when finalized, will
BILLING CODE 4164–01–P Parent Study. Through this information
represent the Agency’s current thinking
collection, ACF seeks to gain an in-
on formal meetings between FDA and
depth, systematic understanding of the
sponsors or applicants of PDUFA DEPARTMENT OF HEALTH AND characteristics of two-parent families
products. It does not create or confer HUMAN SERVICES participating in or eligible to receive
any rights for or on any person and does
TANF, the variety of services two-parent
not operate to bind FDA or the public. Food and Drug Administration families receive through TANF, how
An alternative approach may be used if
[Docket No. FDA–2015–N–0001] state policies may affect participation in
such approach satisfies the
TANF among two-parent families, and
requirements of the applicable statutes Arthritis Advisory Committee: Notice how the beliefs of staff and eligible
and regulations. of Postponement of Meeting families affect two-parent families’
II. The Paperwork Reduction Act of participation in TANF.
AGENCY: Food and Drug Administration,
1995 HHS. The proposed information collection
This draft guidance refers to ACTION: Notice. consists of semi-structured interviews
previously approved collections of with key State and local staff,
information that are subject to review by SUMMARY: The Food and Drug community-based organization
the Office of Management and Budget Administration (FDA) is postponing the representatives, and adult members of
(OMB) under the Paperwork Reduction meeting of the Arthritis Advisory two-parent TANF or likely eligible
Act of 1995 (44 U.S.C. 3501–3520). The Committee scheduled for March 17, families on questions of TANF policies,
collections of information referred to in 2015. The meeting was announced in service delivery, and program context,
the guidance entitled ‘‘Formal Meetings the Federal Register of February 10, as well as focus groups with adult
Between the FDA and Sponsors or 2015 (80 FR 7480). The postponement is members of two-parent TANF or likely
Applicants’’ have been approved under due to information requests pending eligible families.
OMB control number 0910–0429. The with the sponsor of the application. A Respondents: State- and local-level
collections of information for Form FDA future meeting date will be announced TANF administrators and staff,
1571 and end-of-phase 2 meetings have in the Federal Register. representatives from community-based
Rmajette on DSK2VPTVN1PROD with NOTICES
been approved under OMB control FOR FURTHER INFORMATION CONTACT: organizations, and adults from two-
number 0910–0014, and collections of Stephanie L. Begansky, Center for Drug parent families on or likely eligible for
information for Form FDA 356h have Evaluation and Research, Food and TANF.
VerDate Sep<11>2014 14:27 Mar 10, 2015 Jkt 235001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\FR\FM\11MRN1.SGM 11MRN1](https://thefederalregister.org/doc/80_FR_12870/page/1.svg)
Document Created: 2015-12-18 11:58:29
Document Modified: 2015-12-18 11:58:29
| 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 | 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: [email protected], 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. | |
| FR Citation | 80 FR 12823 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR