Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry; Availability, 80364-80365 [2015-32323]

Download as PDF 80364 Federal Register / Vol. 80, No. 247 / Thursday, December 24, 2015 / Notices ANNUAL BURDEN ESTIMATES Instrument Number of respondents Number of responses per respondent Average burden hours per response ANA Project Outcomes Assessment Survey ................................................... Estimated Total Annual Burden Hours: .................................................... 85 ........................ 1 ........................ 6 ........................ In compliance with the requirements of Section 506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L’Enfant Promenade SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. Email address: infocollection@ acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Robert Sargis, Reports Clearance Officer. [FR Doc. 2015–32351 Filed 12–23–15; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES mstockstill on DSK4VPTVN1PROD with NOTICES Food and Drug Administration [Docket No. FDA–2015–D–4386] Deviation Reporting for Human Cells, Tissues, and Cellular and TissueBased Products; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. VerDate Sep<11>2014 17:57 Dec 23, 2015 Jkt 238001 ACTION: Notice of availability. 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. SUMMARY: 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. DATES: ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// 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 https://www.regulations.gov. PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 Total burden hours 510 510 • 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 https://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 https:// www.regulations.gov. Submit both E:\FR\FM\24DEN1.SGM 24DEN1 Federal Register / Vol. 80, No. 247 / Thursday, December 24, 2015 / Notices 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: https://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 https:// 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: mstockstill on DSK4VPTVN1PROD with NOTICES 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 VerDate Sep<11>2014 17:57 Dec 23, 2015 Jkt 238001 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 https://www.fda.gov/BiologicsBlood Vaccines/GuidanceCompliance RegulatoryInformation/Guidances/ default.htm or https:// www.regulations.gov. PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 80365 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Health Center Program Health Resources and Services Administration, HHS. ACTION: Notice of Class Deviation from Competition Requirements for the Health Center Program; Notice of Class Deviations from the Requirements for Extensions, Administrative Supplements, and for Announcing these Deviations in the Federal Register for the Health Center Program. AGENCY: In accordance with the Awarding Agency Grants Administration Manual (AAGAM) Chapter 1.03.103, the Bureau of Primary Health Care (BPHC) has been granted class deviations from the requirements for extensions contained in the AAGAM Chapter 2.04.104B–4A.I.a(5)(b) and the requirements for administrative supplements contained in AAGAM Chapter 2.04.104B–4A.4.b to provide additional grant funds during extended budget periods in excess of the allowed maximum. The deviations prevent interruptions in the provision of critical health care services for a funded service area until a new award can be made to an eligible Service Area Competition (SAC) applicant and to conduct an orderly phase-out of Health Center Program activities by the current award recipient. BPHC has also been granted a deviation that allows it to annually announce via the Federal Register the Health Center Program award recipients that received a low cost extension and/ or administrative supplement under the above described deviations. SUPPLEMENTARY INFORMATION: Intended Recipient of the Award: Health Center Program award recipients for service areas that are threatened with a lapse in services due to transitioning award recipients. Amount of Non-Competitive Awards: Varies annually. Period of Supplemental Funding: Awards made beginning in fiscal year 2016 and ongoing. SUMMARY: CFDA Number: 93.224 Authority: Section 330 of the Public Health Service Act, as amended (42 U.S.C. 254b, as amended). E:\FR\FM\24DEN1.SGM 24DEN1

Agencies

[Federal Register Volume 80, Number 247 (Thursday, December 24, 2015)]
[Notices]
[Pages 80364-80365]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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 https://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 https://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: 
https://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 https://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 https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://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
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