[Federal Register Volume 80, Number 17 (Tuesday, January 27, 2015)]
[Notices]
[Pages 4280-4281]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-01410]
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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Products; Draft Guidance for Industry and Food and Drug Administration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; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry and FDA staff entitled
``Current Good Manufacturing Practice Requirements for Combination
Products.'' The guidance describes and explains the final rule on
current good manufacturing practice (CGMP) requirements for combination
products, including presenting general considerations for CGMP
compliance as well as analysis of hypothetical scenarios.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by March 30, 2015.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Current Good Manufacturing Practice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draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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, MD 20993-0002, 301-796-8930.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
and FDA staff entitled ``Current Good Manufacturing Practice
Requirements for Combination Products.'' The guidance provides
background on combination products, including an overview of the final
rule on CGMP requirements for combination products (78 FR 4307, January
22, 2013) (21 CFR part 4) and the role of the lead center and other
Agency components with respect to combination product CGMP issues. The
guidance addresses general considerations for CGMP requirements for
combination products and the purpose and content of specific CGMP
provisions addressed in part 4. The guidance also contains hypothetical
scenarios intended to clarify how to
[[Page 4281]]
comply with certain CGMP requirements addressed in part 4 by presenting
compliance considerations for specific types of combination products.
Throughout the guidance, reference is made to other existing guidance
and additional sources of information addressing CGMP requirements for
drugs, devices, biological products, and human cells, tissues, and
cellular and tissue-based products (HCT/Ps). Concurrent with
publication of this draft guidance, FDA is withdrawing the draft
guidance for industry and FDA staff entitled ``Current Good
Manufacturing Practice for Combination Products,'' which was issued in
September 2004.
II. Significance of Guidance
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 CGMP
requirements for combination 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 statute and regulations.
III. Paperwork Reduction Act
This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
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). We
note that the information collected under the underlying CGMP
regulations for drugs, devices, and biological products, including
current good tissue practices for HCT/Ps, found at 21 CFR parts 211,
820, 600 through 680, and 1271, have already been approved and are in
effect. The provisions of part 211 are approved under the Office of
Management and Budget (OMB) control number 0910-0139. The provisions of
part 820 are approved under OMB control number 0910-0073. The
provisions of parts 606, 640, and 660 are approved under OMB control
number 0910-0116. The provisions of part 610 are approved under OMB
control number 0910-0116 and OMB control number 0910-0338 (also for
part 680). The provisions of part 1271, subparts C and D, are approved
under OMB control number 0910-0543.
IV. Comments
Interested persons may submit either electronic comments regarding
this document to http://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 http://www.regulations.gov.
V. Electronic Access
Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Regulatory Information/Guidances/
ucm126198.htm or http://www.regulations.gov.
Dated: January 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-01410 Filed 1-26-15; 8:45 am]
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