[Federal Register Volume 82, Number 7 (Wednesday, January 11, 2017)]
[Notices]
[Pages 3336-3338]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00411]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Current Good Manufacturing Practice Requirements for Combination 
Products; Guidance for Industry and Food and Drug Administration Staff; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a final guidance for industry and FDA staff entitled 
``Current Good Manufacturing Practice Requirements for Combination 
Products.'' The guidance describes and explains the document on current 
good manufacturing practice (CGMP) requirements for combination 
products, which published in the Federal Register of January 22, 2013, 
and includes general considerations for CGMP compliance as well as 
analysis of hypothetical scenarios.

[[Page 3337]]


DATES: Submit either electronic or written comments on this guidance at 
any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-D-0198 for ``Current Good Manufacturing Practice Requirements 
for Combination Products; Final Guidance for Industry and FDA Staff.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the 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 guidance document.

FOR FURTHER INFORMATION CONTACT: Melissa Burns or 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 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 document on CGMP 
requirements for combination products, which published in the Federal 
Register of January 22, 2013 (78 FR 4307), 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 (21 CFR part 4). The 
guidance also contains hypothetical scenarios intended to clarify how 
to comply with certain CGMP requirements addressed in part 4 by 
presenting compliance considerations for specific types of combination 
products.
    FDA carefully considered the comments received on the draft 
guidance, and, where possible, has incorporated into the final guidance 
additional detailed discussion of how the requirements apply and 
acceptable CGMP compliance approaches. FDA encourages combination 
product manufacturers to contact the lead Center for their combination 
product and/or the Office of Combination Products if they have 
questions on CGMP compliance or approaches they are considering for 
meeting CGMP requirements.

II. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM429304.pdf.

III. Paperwork Reduction Act

    This 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 human cells, tissues, and cellular 
and tissue-based products, found at parts 211, 820, 600 through 680, 
and 1271 (21 CFR parts

[[Page 3338]]

211, 820, 600 through 680, and 1271), have already been approved and 
are in effect. The provisions of part 211 are approved under OMB 
control number 0910-0139. The provisions of part 820 are approved under 
OMB control number 0910-0073. The provisions of parts 606 and 640 are 
approved under OMB control number 0910-0116. The provisions of part 610 
are approved under OMB control numbers 0910-0116 and 0910-0338 (also 
for part 680). The provisions of part 1271, subparts C and D, are 
approved under OMB control number 0910-0543.

    Dated: January 6, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00411 Filed 1-10-17; 8:45 am]
 BILLING CODE 4164-01-P