Current Good Manufacturing Practice Requirements for Combination Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 4280-4281 [2015-01410]

Download as PDF 4280 Federal Register / Vol. 80, No. 17 / Tuesday, January 27, 2015 / Notices IV. List of Recognized Standards FDA maintains the Agency’s current list of FDA Recognized Consensus Standards in a searchable database that may be accessed directly at FDA’s Internet site at https:// www.accessdata.fda.gov/scripts/cdrh/ cfdocs/cfStandards/search.cfm. FDA will incorporate the modifications and revisions described in this notice into the database and, upon publication in the Federal Register, this recognition of consensus standards will be effective. FDA will announce additional modifications and revisions to the list of recognized consensus standards, as needed, in the Federal Register once a year, or more often if necessary. Beginning with Recognition List 033, FDA no longer announces minor revisions to the list of recognized consensus standards such as technical contact person, devices affected, processes affected, Code of Federal Regulations citations, and product codes. announcing ‘‘Modification to the List of Recognized Standards, Recognition List Number: 038’’ will be available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ Standards/ucm123792.htm. You may access ‘‘Guidance on the Recognition and Use of Consensus Standards,’’ and the searchable database for ‘‘FDA Recognized Consensus Standards’’ at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ Standards. VII. Submission of Comments and Effective Date 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 V. Recommendation of Standards for will be posted to the docket at https:// Recognition by FDA www.regulations.gov. FDA will consider Any person may recommend any comments received in determining consensus standards as candidates for whether to amend the current listing of recognition under section 514 of the modifications to the list of recognized FD&C Act by submitting such standards, Recognition List Number: recommendations, with reasons for the 038. These modifications to the list of recommendation to standards@ recognized standards are effective upon cdrh.fda.gov. To be properly considered, publication of this notice in the Federal such recommendations should contain, Register. at a minimum, the following Dated: January 22, 2015. information: (1) Title of the standard, (2) Leslie Kux, any reference number and date, (3) Associate Commissioner for Policy. name and address of the national or [FR Doc. 2015–01420 Filed 1–26–15; 8:45 am] international standards development BILLING CODE 4164–01–P organization, (4) a proposed list of devices for which a declaration of conformity to this standard should DEPARTMENT OF HEALTH AND routinely apply, and (5) a brief HUMAN SERVICES identification of the testing or Food and Drug Administration VI. Electronic Access asabaliauskas on DSK5VPTVN1PROD with NOTICES performance or other characteristics of the device(s) that would be addressed by a declaration of conformity. Current Good Manufacturing Practice Requirements for Combination Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability You may obtain a copy of ‘‘Guidance on the Recognition and Use of Consensus Standards’’ by using the Internet. The Center for Devices and Radiological Health (CDRH) maintains a site on the Internet for easy access to information including text, graphics, and files that you may download to a personal computer with access to the Internet. Updated on a regular basis, the CDRH home page, https://www.fda.gov/ MedicalDevices, includes a link to standards-related documents including the guidance and the current list of recognized standards. After publication in the Federal Register, this notice VerDate Sep<11>2014 18:01 Jan 26, 2015 Jkt 235001 [Docket No. FDA–2015–D–0198] AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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 SUMMARY: PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 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 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, 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 E:\FR\FM\27JAN1.SGM 27JAN1 Federal Register / Vol. 80, No. 17 / Tuesday, January 27, 2015 / Notices 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. asabaliauskas on DSK5VPTVN1PROD with NOTICES 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 VerDate Sep<11>2014 18:01 Jan 26, 2015 Jkt 235001 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. V. 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: January 21, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–01410 Filed 1–26–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–D–1849] Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails.’’ This guidance is intended to provide recommendations when finalized regarding clinical trial design for medical devices intended either to provide improvement in the appearance of nails affected by onychomycosis or to treat onychomycosis (fungal nail infection). This draft guidance is not final nor is it in effect at this time. 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 of 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 April 27, 2015. SUMMARY: PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 4281 An electronic copy of the guidance document is available for download from the Internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the draft guidance document entitled ‘‘Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails’’ to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your request. 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: Neil Ogden, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G414, Silver Spring, MD 20993–0002, 301–796–6397. SUPPLEMENTARY INFORMATION: ADDRESSES: I. Background FDA is announcing the availability of a draft guidance for industry and FDA staff entitled ‘‘Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails.’’ This guidance is intended to provide recommendations when finalized regarding clinical trial design for medical devices intended either: (1) To provide improvement in the appearance of nails affected by onychomycosis, that is, to affect the structure/function of the nails or (2) to treat onychomycosis (fungal nail infection). The FDA distinguishes these two conditions as target outcomes. The treatment of onychomycosis (an infectious disease) requires proof of stable elimination of the fungal organism, which is a medical endpoint. This outcome is distinct from outcomes limited to ‘‘temporary increase in clear nail’’ in nails which are fungally infected, which is considered an aesthetic endpoint, and does not connote successful eradication of fungal infection. The need for clinical performance data will be dependent on E:\FR\FM\27JAN1.SGM 27JAN1

Agencies

[Federal Register Volume 80, Number 17 (Tuesday, January 27, 2015)]
[Notices]
[Pages 4280-4281]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01410]


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

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.

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

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 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, 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 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.

V. 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: January 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-01410 Filed 1-26-15; 8:45 am]
BILLING CODE 4164-01-P
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