Current Good Manufacturing Practice Requirements for Combination Products; Draft Guidance for Industry and Food and Drug Administration Staff; Extension of Comment Period, 13382-13383 [2015-05674]

Download as PDF mstockstill on DSK4VPTVN1PROD with NOTICES 13382 Federal Register / Vol. 80, No. 49 / Friday, March 13, 2015 / Notices alternative regulatory approaches, we selected those approaches that would maximize net benefits. Based on the analysis that follows, the Department believes that these proposed priorities are consistent with the principles in Executive Order 13563. We also have determined that this regulatory action would not unduly interfere with State, local, and tribal governments in the exercise of their governmental functions. In accordance with both Executive Orders, the Department has assessed the potential costs and benefits, both quantitative and qualitative, of this regulatory action. The potential costs are those resulting from statutory requirements and those we have determined as necessary for administering the Department’s programs and activities. The benefits of the Disability and Rehabilitation Research Projects and Centers Program have been well established over the years. Projects similar to ones envisioned by the proposed priorities have been completed successfully, and the proposed priorities would generate new knowledge through research. The new DRRPs would generate, disseminate, and promote the use of new information that would improve outcomes for individuals with disabilities. Intergovernmental Review: This program is not subject to Executive Order 12372. Electronic Access to This Document: The official version of this document is the document published in the Federal Register. Free Internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.gpo.gov/fdsys. At this site you can view this document, as well as all other documents of this Department published in the Federal Register, in text or Adobe Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site. You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department. DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Food and Drug Administration Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting [Docket No. FDA–2015–D–0198] Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in section 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Child Health and Human Development Special Emphasis Panel; Wellstone Centers for Muscular Dystrophy. Date: April 27–28, 2015. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Embassy Suite at the Chevy Chase Pavilion, Washington, DC 20115. Contact Person: Cathy J. Wedeen, Ph.D., Scientific Review Officer, Scientific Review Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, 6100 Executive Boulevard, Room 5B01–G, Bethesda, MD 20892–9304, (301) 435–6878, wedeenc@mail .nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS) Dated: March 9, 2015. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–05706 Filed 3–12–15; 8:45 am] BILLING CODE 4140–01–P Dated: March 3, 2015. Kathy Greenlee, Administrator. [FR Doc. 2015–05333 Filed 3–12–15; 8:45 am] BILLING CODE 4154–01–P VerDate Sep<11>2014 19:27 Mar 12, 2015 Jkt 235001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 Current Good Manufacturing Practice Requirements for Combination Products; Draft Guidance for Industry and Food and Drug Administration Staff; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension of comment period. The Food and Drug Administration (FDA) is extending the comment period by 30 days to April 29, 2015, for the notice entitled ‘‘Current Good Manufacturing Practice Requirements for Combination Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability,’’ that appeared in the Federal Register of January 27, 2015 (80 FR 4280). In that document, FDA announced the availability of a draft guidance for industry and FDA staff and requested comments. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments. DATES: FDA is extending the comment period on the draft guidance. Submit either electronic or written comments by April 29, 2015. ADDRESSES: Submit written requests for single copies of the draft guidance document entitled ‘‘Current Good Manufacturing Practice Requirements for Combination Products’’ to the Office of Combination Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance to https://www. regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: John Barlow Weiner, Office of Combination Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, SUMMARY: E:\FR\FM\13MRN1.SGM 13MRN1 Federal Register / Vol. 80, No. 49 / Friday, March 13, 2015 / Notices MD 20993–0002, 301–796–8930, email: John.Weiner@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of January 27, 2015 (80 FR 4280), FDA published a notice with a 60-day comment period to request comments on the draft guidance for industry and FDA staff entitled ‘‘Current Good Manufacturing Practice Requirements for Combination Products.’’ The Agency received a request for a 30-day extension of the comment period for the draft guidance. The request conveyed concern that the current 60day comment period does not allow sufficient time to respond. FDA has considered the request and is extending the comment period for the draft guidance for 30 days, until April 29, 2015. The Agency believes that a 30-day extension allows adequate time for interested persons to submit comments without significantly delaying further FDA action on this guidance document. II. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. III. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Regulatory Information/Guidances/ucm126198.htm or https://www.regulations.gov. Dated: March 9, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–05674 Filed 3–12–15; 8:45 am] BILLING CODE 4164–01–P mstockstill on DSK4VPTVN1PROD with NOTICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Advisory Committee for Women’s Services (ACWS); Notice of Meeting Pursuant to Public Law 92–463, notice is hereby given of a meeting of the Substance Abuse and Mental Health VerDate Sep<11>2014 19:27 Mar 12, 2015 Jkt 235001 Services Administration’s (SAMHSA) Advisory Committee for Women’s Services (ACWS) on April 15, 2015. The meeting will include discussions on lesbian, bisexual and transgender issues; high-risk/high-need girls and young women; supporting women in coed settings—core competencies, practices and strategies; SAMHSA’s Pregnant and Post-Partum Women Grant Program; and a conversation with the SAMHSA Administrator. The meeting is open to the public and will be held at SAMHSA, 1 Choke Cherry Road, Rockville, MD 20850, in the Rock Creek Conference Room. Attendance by the public will be limited to space available. Interested persons may present data, information, or views, orally or in writing, on issues pending before the Committee. Written submissions should be forwarded to the contact person (below) on or before April 7, 2015. Oral presentations from the public will be scheduled at the conclusion of the meeting. Individuals interested in making oral presentations are encouraged to notify the contact person on or before April 7, 2015. Five minutes will be allotted for each presentation. The meeting may be accesed via telephone. To attend on site, obtain the call-in number and access code, submit written or brief oral comments, or request special accommodations for persons with disabilities, please register on-line at: https://nac.samhsa.gov/ Registration/meetingsRegistration.aspx, or communicate with SAMHSA’s Designated Federal Officer, Ms. Nadine Benton (see contact information below). Substantive meeting information and a roster of Committee members may be obtained either by accessing the SAMHSA Committees’ Web site at: https://www.samhsa.gov/about-us/ advisory-councils/advisory-committeewomen%E2%80%99s-services-awcs, or by contacting Ms. Benton. Committee Name: Substance Abuse and Mental Health Services Administration Advisory Committee for Women’s Services (ACWS). Date/Time/Type: Wednesday, April 15, 2015, from 9:00 a.m. to 5:15 p.m. EDT: Open. Place: SAMHSA, 1 Choke Cherry Road, Rock Creek Conference Room, Rockville, Maryland 20850. Contact: Nadine Benton, Designated Federal Official, SAMHSA’s Advisory Committee for Women’s Services, 1 Choke Cherry Road, Rockville, Maryland 20857 (mail), Telephone: PO 00000 Frm 00062 Fmt 4703 Sfmt 9990 13383 (240) 276–0127, Fax: (240) 276–2252, Email: nadine.benton@samhsa.hhs.gov. Summer King, Statistician, SAMHSA. [FR Doc. 2015–05816 Filed 3–12–15; 8:45 am] BILLING CODE 4162–20–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Center for Substance Abuse Prevention; Notice of Meeting Pursuant to Public Law 92–463, notice is hereby given that the Substance Abuse and Mental Health Services Administration’s (SAMHSA) Center for Substance Abuse Prevention (CSAP) Drug Testing Advisory Board (DTAB) will meet via web conference on April 9, 2015, from 10:00 a.m. to 3:30 p.m. E.D.T. The Board will meet in closed session to discuss confidential research data, as well as proposed revisions to the Mandatory Guidelines for Federal Workplace Drug Testing Programs. Therefore, this meeting is closed to the public as determined by the Administrator, SAMHSA, in accordance with 5 U.S.C. 552b(c)(4), 5 U.S.C. 552b(c)(9)(B), and 5 U.S.C. App. 2, Section 10(d). Meeting information and a roster of DTAB members may be obtained by accessing the SAMHSA Advisory Committees Web site, https://www. samhsa.gov/about-us/advisory-councils/ drug-testing-advisory-board-dtab, or by contacting Dr. Cook. Committee Name: Substance Abuse and Mental Health Services Administration’s Center for Substance Abuse Prevention Drug Testing Advisory Board. Dates/Time/Type: April 9, 2015, from 10:00 a.m. to 3:30 p.m. E.D.T.: CLOSED. Place: SAMHSA Building, 1 Choke Cherry Road, Rockville, Maryland 20850. Contact: Janine Denis Cook, Ph.D., Designated Federal Official, CSAP Drug Testing Advisory Board, 1 Choke Cherry Road, Room 7–1043, Rockville, Maryland 20857, Telephone: 240–276–2600, Fax: 240– 276–2610, Email: janine.cook@ samhsa.hhs.gov. Janine Denis Cook, Designated Federal Official, DTAB, Division of Workplace Programs, Center for Substance Abuse Prevention, Substance Abuse and Mental Health Services Administration. [FR Doc. 2015–05749 Filed 3–12–15; 8:45 am] BILLING CODE 4162–20–P E:\FR\FM\13MRN1.SGM 13MRN1

Agencies

[Federal Register Volume 80, Number 49 (Friday, March 13, 2015)]
[Notices]
[Pages 13382-13383]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-05674]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-0198]


Current Good Manufacturing Practice Requirements for Combination 
Products; Draft Guidance for Industry and Food and Drug Administration 
Staff; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA) is extending the 
comment period by 30 days to April 29, 2015, for the notice entitled 
``Current Good Manufacturing Practice Requirements for Combination 
Products; Draft Guidance for Industry and Food and Drug Administration 
Staff; Availability,'' that appeared in the Federal Register of January 
27, 2015 (80 FR 4280). In that document, FDA announced the availability 
of a draft guidance for industry and FDA staff and requested comments. 
The Agency is taking this action in response to a request for an 
extension to allow interested persons additional time to submit 
comments.

DATES: FDA is extending the comment period on the draft guidance. 
Submit either electronic or written comments by April 29, 2015.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Current Good Manufacturing Practice 
Requirements for Combination Products'' to the Office of Combination 
Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
32, Rm. 5129, Silver Spring, MD 20993-0002. Send one self-addressed 
adhesive label to assist that office in processing your request. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
draft guidance document.
    Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: John Barlow Weiner, Office of 
Combination Products, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 32, Rm. 5129, Silver Spring,

[[Page 13383]]

MD 20993-0002, 301-796-8930, email: John.Weiner@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of January 27, 2015 (80 FR 4280), FDA 
published a notice with a 60-day comment period to request comments on 
the draft guidance for industry and FDA staff entitled ``Current Good 
Manufacturing Practice Requirements for Combination Products.''
    The Agency received a request for a 30-day extension of the comment 
period for the draft guidance. The request conveyed concern that the 
current 60-day comment period does not allow sufficient time to 
respond. FDA has considered the request and is extending the comment 
period for the draft guidance for 30 days, until April 29, 2015. The 
Agency believes that a 30-day extension allows adequate time for 
interested persons to submit comments without significantly delaying 
further FDA action on this guidance document.

II. Comments

    Interested persons may submit either electronic comments regarding 
this document to https://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either https://www.fda.gov/RegulatoryInformation/Guidances/ucm126198.htm 
or https://www.regulations.gov.

    Dated: March 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05674 Filed 3-12-15; 8:45 am]
BILLING CODE 4164-01-P
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