Document ID: FDA-2014-D-1584-0001
Agency: fda
Document Type: Proposed Rule
Title: Same Surgical Procedure Exception Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry; Availability
Posted Date: 2014-10-23T04:00Z

[Federal Register Volume 79, Number 205 (Thursday, October 23, 2014)]
[Proposed Rules]
[Pages 63348-63349]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-25217]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1271

[Docket No. FDA-2014-D-1584]

Same Surgical Procedure Exception Questions and Answers Regarding 
the Scope of the Exception; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Request for comment on draft guidance.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft document entitled ``Same Surgical Procedure 
Exception Questions and Answers Regarding the Scope of the Exception'' 
dated October 2014. The draft guidance document is intended for tissue 
establishments and healthcare

[[Page 63349]]

professionals and discusses one of the exceptions for establishments 
from certain regulatory requirements.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by December 22, 2014

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Outreach, and Development, 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 The draft guidance may also be 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 240-402-7800. 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draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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.

FOR FURTHER INFORMATION CONTACT: Lori J. Churchyard, 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 
``Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions 
and Answers Regarding the Scope of the Exception'' dated October 2014. 
The draft guidance document is intended for use by tissue 
establishments and healthcare professionals. When finalized, the 
guidance document will provide our current thinking with respect to the 
exception set forth in Title 21 of the Code of Federal Regulations 
1271.15(b) (21 CFR 1271.15(b)). The draft guidance is presented in 
question and answer format and includes examples based on inquiries 
received by the Agency since the final rule, ``Human Cells, Tissues, 
and Cellular and Tissue Based Products; Establishment Registration and 
Listing'' published in the Federal Register of January 19, 2001 (66 FR 
5447).
    The draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent FDA's current thinking on this topic. 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 requirement of the applicable statutes 
and regulations.

II. Paperwork Reduction Act of 1995

    The 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. Comments

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

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: October 17, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-25217 Filed 10-22-14; 8:45 am]
BILLING CODE 4164-01-P