[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Products; Draft Guidance for Industry and Food and Drug Administration 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availability of a draft guidance for industry and FDA staff entitled 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by March 30, 2015.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Current Good Manufacturing Practice 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draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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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