80_FR_80611 80 FR 80364 - Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry; Availability

80 FR 80364 - Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 247 (December 24, 2015)

Page Range80364-80365
FR Document2015-32323

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR part 1271; Draft Guidance for Industry.'' The draft guidance document provides certain establishments that manufacture non-reproductive human cells, tissues, and cellular and tissue-based products (HCT/Ps), regulated solely under the Public Health Service Act (PHS Act) and under FDA regulations, with recommendations and relevant examples for complying with the requirements to report HCT/P deviations.

Federal Register, Volume 80 Issue 247 (Thursday, December 24, 2015) 
[Federal Register Volume 80, Number 247 (Thursday, December 24, 2015)]
[Notices]
[Pages 80364-80365]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-32323]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-4386]


Deviation Reporting for Human Cells, Tissues, and Cellular and 
Tissue-Based Products; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft document entitled ``Deviation Reporting for 
Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated 
Solely Under Section 361 of the Public Health Service Act and 21 CFR 
part 1271; Draft Guidance for Industry.'' The draft guidance document 
provides certain establishments that manufacture non-reproductive human 
cells, tissues, and cellular and tissue-based products (HCT/Ps), 
regulated solely under the Public Health Service Act (PHS Act) and 
under FDA regulations, with recommendations and relevant examples for 
complying with the requirements to report HCT/P deviations.

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 23, 2016.

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-4386 for ``Deviation Reporting for Human Cells, Tissues, 
and Cellular and Tissue-Based Products Regulated Solely Under Section 
361 of the Public Health Service Act and 21 CFR part 1271; Draft 
Guidance for Industry.'' 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

[[Page 80365]]

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 draft guidance to 
the Office of Communication, Outreach and Development, Center for 
Biologics Evaluation and Research (CBER), Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist the office in 
processing your requests. The draft guidance may also be obtained by 
mail by calling CBER at 1-800-835-4709 or 240-402-8010. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance document.

FOR FURTHER INFORMATION CONTACT: Tami Belouin, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled 
``Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue 
Based Products Regulated Solely Under Section 361 of the Public Health 
Service Act and 21 CFR part 1271; Draft Guidance for Industry.'' The 
document provides certain establishments that manufacture HCT/Ps, 
regulated solely under section 361 of the PHS Act and the regulations 
under 21 CFR part 1271, with recommendations and relevant examples for 
complying with the requirements under 21 CFR 1271.350(b) to report HCT/
P deviations. The examples provided in the draft guidance are intended 
to illustrate those HCT/P deviations that have been most frequently 
reported to FDA, CBER.
    The draft guidance does not apply to reproductive HCT/Ps or to HCT/
Ps regulated under 21 CFR part 1270 and recovered before May 25, 2005. 
The draft guidance does not apply to health professionals who implant, 
transplant, infuse, or transfer HCT/Ps into recipients. The draft 
guidance also does not apply to HCT/Ps that are regulated as drugs, 
devices, and/or biological products under section 351 of the PHS Act 
and/or the Federal Food, Drug, and Cosmetic Act, nor does it apply to 
investigational HCT/Ps subject to an investigational new drug 
application or an investigational device exemption.
    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 current thinking of FDA on Deviation 
Reporting for Human Cells, Tissues, and Cellular and Tissue Based 
Products Regulated Solely Under section 361 of the Public Health 
Service Act and 21 CFR part 1271. It does not establish any rights for 
any person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.

II. Paperwork Reduction Act of 1995

    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). The 
collections of information in 21 CFR part 1271 have been approved under 
OMB control number 0910-0543.

III. Other Issues for Consideration

    The draft guidance is being distributed for comment purposes only 
and is not intended for implementation at this time.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: December 18, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-32323 Filed 12-23-15; 8:45 am]
 BILLING CODE 4164-01-P

80364 Federal Register / Vol. 80, No. 247 / Thursday, December 24, 2015 / Notices ANNUAL BURDEN ESTIMATES Number of Average Number of Total burden Instrument responses per burden hours respondents hours respondent per response ANA Project Outcomes Assessment Survey ................................................... 85 1 6 510 Estimated Total Annual Burden Hours: .................................................... ........................ ........................ ........................ 510 In compliance with the requirements ACTION: Notice of availability. • If you want to submit a comment of Section 506(c)(2)(A) of the Paperwork with confidential information that you Reduction Act of 1995, the SUMMARY: The Food and Drug do not wish to be made available to the Administration for Children and Administration (FDA or Agency) is public, submit the comment as a Families is soliciting public comment announcing the availability of a draft written/paper submission and in the on the specific aspects of the document entitled ‘‘Deviation Reporting manner detailed (see ‘‘Written/Paper information collection described above. for Human Cells, Tissues, and Cellular Submissions’’ and ‘‘Instructions’’). Copies of the proposed collection of and Tissue-Based Products Regulated information can be obtained and Solely Under Section 361 of the Public Written/Paper Submissions comments may be forwarded by writing Health Service Act and 21 CFR part Submit written/paper submissions as to the Administration for Children and 1271; Draft Guidance for Industry.’’ The follows: Families, Office of Planning, Research draft guidance document provides • Mail/Hand delivery/Courier (for and Evaluation, 370 L’Enfant certain establishments that manufacture written/paper submissions): Division of Promenade SW., Washington, DC 20447, non-reproductive human cells, tissues, Dockets Management (HFA–305), Food Attn: ACF Reports Clearance Officer. and cellular and tissue-based products and Drug Administration, 5630 Fishers Email address: infocollection@ (HCT/Ps), regulated solely under the Lane, Rm. 1061, Rockville, MD 20852. acf.hhs.gov. All requests should be Public Health Service Act (PHS Act) and • For written/paper comments identified by the title of the information under FDA regulations, with submitted to the Division of Dockets collection. recommendations and relevant Management, FDA will post your The Department specifically requests examples for complying with the comment, as well as any attachments, comments on: (a) Whether the proposed requirements to report HCT/P except for information submitted, collection of information is necessary deviations. marked and identified, as confidential, for the proper performance of the if submitted as detailed in DATES: Although you can comment on functions of the agency, including ‘‘Instructions.’’ any guidance at any time (see 21 CFR whether the information shall have Instructions: All submissions received 10.115(g)(5)), to ensure that the Agency practical utility; (b) the accuracy of the must include the Docket No. FDA– agency’s estimate of the burden of the considers your comment on this draft 2015–D–4386 for ‘‘Deviation Reporting proposed collection of information; (c) guidance before it begins work on the for Human Cells, Tissues, and Cellular the quality, utility, and clarity of the final version of the guidance, submit and Tissue-Based Products Regulated information to be collected; and (d) either electronic or written comments Solely Under Section 361 of the Public ways to minimize the burden on the draft guidance by March 23, Health Service Act and 21 CFR part information to be collected; and (d) 2016. 1271; Draft Guidance for Industry.’’ ways to minimize the burden of the ADDRESSES: You may submit comments Received comments will be placed in collection of information on as follows: the docket and, except for those respondents, including through the use submitted as ‘‘Confidential of automated collection techniques or Electronic Submissions Submissions,’’ publicly viewable at other forms of information technology. Submit electronic comments in the http://www.regulations.gov or at the Consideration will be given to following way: Division of Dockets Management comments and suggestions submitted • Federal eRulemaking Portal: http:// between 9 a.m. and 4 p.m., Monday within 60 days of this publication. www.regulations.gov. Follow the through Friday. Robert Sargis, instructions for submitting comments. • Confidential Submissions—To Comments submitted electronically, submit a comment with confidential Reports Clearance Officer. including attachments, to http:// information that you do not wish to be [FR Doc. 2015–32351 Filed 12–23–15; 8:45 am] www.regulations.gov will be posted to made publicly available, submit your BILLING CODE 4184–01–P the docket unchanged. Because your comments only as a written/paper comment will be made public, you are submission. You should submit two solely responsible for ensuring that your copies total. One copy will include the DEPARTMENT OF HEALTH AND comment does not include any information you claim to be confidential HUMAN SERVICES confidential information that you or a with a heading or cover note that states Food and Drug Administration third party may not wish to be posted, ‘‘THIS DOCUMENT CONTAINS such as medical information, your or CONFIDENTIAL INFORMATION’’. The [Docket No. FDA–2015–D–4386] mstockstill on DSK4VPTVN1PROD with NOTICES anyone else’s Social Security number, or Agency will review this copy, including confidential business information, such the claimed confidential information, in Deviation Reporting for Human Cells, as a manufacturing process. Please note its consideration of comments. The Tissues, and Cellular and Tissue- that if you include your name, contact second copy, which will have the Based Products; Draft Guidance for information, or other information that claimed confidential information Industry; Availability identifies you in the body of your redacted/blacked out, will be available AGENCY: Food and Drug Administration, comments, that information will be for public viewing and posted on http:// HHS. posted on http://www.regulations.gov. www.regulations.gov. Submit both VerDate Sep<11>2014 17:57 Dec 23, 2015 Jkt 238001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\24DEN1.SGM 24DEN1

Federal Register / Vol. 80, No. 247 / Thursday, December 24, 2015 / Notices 80365 copies to the Division of Dockets examples for complying with the Dated: December 18, 2015. Management. If you do not wish your requirements under 21 CFR 1271.350(b) Leslie Kux, name and contact information to be to report HCT/P deviations. The Associate Commissioner for Policy. made publicly available, you can examples provided in the draft guidance [FR Doc. 2015–32323 Filed 12–23–15; 8:45 am] provide this information on the cover are intended to illustrate those HCT/P BILLING CODE 4164–01–P sheet and not in the body of your deviations that have been most comments and you must identify this frequently reported to FDA, CBER. information as ‘‘confidential.’’ Any The draft guidance does not apply to DEPARTMENT OF HEALTH AND information marked as ‘‘confidential’’ HUMAN SERVICES reproductive HCT/Ps or to HCT/Ps will not be disclosed except in regulated under 21 CFR part 1270 and Health Resources and Services accordance with 21 CFR 10.20 and other recovered before May 25, 2005. The Administration applicable disclosure law. For more draft guidance does not apply to health information about FDA’s posting of professionals who implant, transplant, Health Center Program comments to public dockets, see 80 FR 56469, September 18, 2015, or access infuse, or transfer HCT/Ps into recipients. The draft guidance also does AGENCY: Health Resources and Services the information at: http://www.fda.gov/ Administration, HHS. regulatoryinformation/dockets/ not apply to HCT/Ps that are regulated as drugs, devices, and/or biological ACTION: Notice of Class Deviation from default.htm. Competition Requirements for the Docket: For access to the docket to products under section 351 of the PHS Act and/or the Federal Food, Drug, and Health Center Program; Notice of Class read background documents or the Deviations from the Requirements for electronic and written/paper comments Cosmetic Act, nor does it apply to investigational HCT/Ps subject to an Extensions, Administrative received, go to http:// Supplements, and for Announcing these www.regulations.gov and insert the investigational new drug application or an investigational device exemption. Deviations in the Federal Register for docket number, found in brackets in the the Health Center Program. heading of this document, into the This draft guidance is being issued ‘‘Search’’ box and follow the prompts consistent with FDA’s good guidance SUMMARY: In accordance with the and/or go to the Division of Dockets practices regulation (21 CFR 10.115). Awarding Agency Grants Management, 5630 Fishers Lane, Rm. The draft guidance, when finalized, will Administration Manual (AAGAM) 1061, Rockville, MD 20852. represent the current thinking of FDA Chapter 1.03.103, the Bureau of Primary Submit written requests for single on Deviation Reporting for Human Health Care (BPHC) has been granted copies of the draft guidance to the Office Cells, Tissues, and Cellular and Tissue class deviations from the requirements of Communication, Outreach and Based Products Regulated Solely Under for extensions contained in the AAGAM Development, Center for Biologics section 361 of the Public Health Service Chapter 2.04.104B–4A.I.a(5)(b) and the Evaluation and Research (CBER), Food Act and 21 CFR part 1271. It does not requirements for administrative and Drug Administration, 10903 New establish any rights for any person and supplements contained in AAGAM Hampshire Ave., Bldg. 71, Rm. 3128, is not binding on FDA or the public. Chapter 2.04.104B–4A.4.b to provide Silver Spring, MD 20993–0002. Send You can use an alternative approach if additional grant funds during extended one self-addressed adhesive label to it satisfies the requirements of the budget periods in excess of the allowed assist the office in processing your applicable statutes and regulations. maximum. The deviations prevent requests. The draft guidance may also be interruptions in the provision of critical obtained by mail by calling CBER at 1– II. Paperwork Reduction Act of 1995 health care services for a funded service 800–835–4709 or 240–402–8010. See area until a new award can be made to This draft guidance refers to the SUPPLEMENTARY INFORMATION section an eligible Service Area Competition previously approved collections of for electronic access to the draft (SAC) applicant and to conduct an information found in FDA regulations. guidance document. orderly phase-out of Health Center These collections of information are Program activities by the current award FOR FURTHER INFORMATION CONTACT: subject to review by the Office of Tami Belouin, Center for Biologics recipient. BPHC has also been granted a Management and Budget (OMB) under deviation that allows it to annually Evaluation and Research, Food and the Paperwork Reduction Act of 1995 Drug Administration, 10903 New announce via the Federal Register the (44 U.S.C. 3501–3520). The collections Health Center Program award recipients Hampshire Ave., Bldg. 71, Rm. 7301, of information in 21 CFR part 1271 have Silver Spring, MD 20993–0002, 240– that received a low cost extension and/ been approved under OMB control or administrative supplement under the 402–7911. number 0910–0543. SUPPLEMENTARY INFORMATION: above described deviations. III. Other Issues for Consideration SUPPLEMENTARY INFORMATION: Intended I. Background Recipient of the Award: Health Center FDA is announcing the availability of The draft guidance is being Program award recipients for service a draft document entitled ‘‘Deviation distributed for comment purposes only areas that are threatened with a lapse in Reporting for Human Cells, Tissues, and and is not intended for implementation services due to transitioning award Cellular and Tissue Based Products at this time. recipients. Regulated Solely Under Section 361 of Amount of Non-Competitive Awards: IV. Electronic Access Varies annually. mstockstill on DSK4VPTVN1PROD with NOTICES the Public Health Service Act and 21 CFR part 1271; Draft Guidance for Persons with access to the Internet Period of Supplemental Funding: Industry.’’ The document provides may obtain the draft guidance at either Awards made beginning in fiscal year certain establishments that manufacture http://www.fda.gov/BiologicsBlood 2016 and ongoing. HCT/Ps, regulated solely under section Vaccines/GuidanceCompliance CFDA Number: 93.224 361 of the PHS Act and the regulations RegulatoryInformation/Guidances/ Authority: Section 330 of the Public Health under 21 CFR part 1271, with default.htm or http:// Service Act, as amended (42 U.S.C. 254b, as recommendations and relevant www.regulations.gov. amended). VerDate Sep<11>2014 17:57 Dec 23, 2015 Jkt 238001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\24DEN1.SGM 24DEN1


Document Created: 2015-12-24 02:24:48
Document Modified: 2015-12-24 02:24:48
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesAlthough 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 23, 2016.
ContactTami Belouin, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240- 402-7911.
FR Citation80 FR 80364 
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR