Same Surgical Procedure Exception Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry; Availability, 63348-63349 [2014-25217]

Download as PDF 63348 Federal Register / Vol. 79, No. 205 / Thursday, October 23, 2014 / Proposed Rules TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETING AND ON SUBMITTING COMMENTS TO THE RULEMAKING DOCKETS Date Electronic address Public meeting ..................... November 13, 2014 Advance registration ............ By November 7, 2014 Request to make an oral presentation. By October 27, 2014 Request special accommodations due to a disability. Submit electronic or written comments. Address Other information http://www.fda.gov/Food/ NewsEvents/Workshops MeetingsConferences/default.htm. Individuals who wish to participate in person are asked to preregister at http://www.fda.gov/Food/ NewsEvents/Workshops MeetingsConferences/default.htm. http://www.fda.gov/Food/ NewsEvents/Workshops MeetingsConferences/default.htm 2. Wiley Building, 5100 Paint Branch Pkwy., College Park, MD 20740. 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Please include your name, title, firm name, address, and phone and FAX numbers in your registration information and send to: Courtney Treece, Planning Professionals Ltd., 1210 W. McDermott St., Suite 111, Allen, TX 75013, 704–258– 4983, FAX: 469–854–6992, email: ctreece@planningprofessionals.com. Onsite registration will also be available. 2 You may also request to make an oral presentation at the public meeting via email. Please include your name, title, firm name, address, and phone and FAX numbers as well as the full text, comprehensive outline, or summary of your oral presentation and send to: Juanita Yates, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240–402–1731, email: Juanita.yates@fda.hhs.gov. mstockstill on DSK4VPTVN1PROD with PROPOSALS III. Comments, Transcripts, and Recorded Video Information and data submitted voluntarily to FDA during the public meeting will become part of the administrative record for the relevant rulemaking and will be accessible to the public at http://www.regulations.gov. The transcript of the proceedings from the public meeting will become part of the administrative record for each of the rulemakings. Please be advised that as soon as a transcript is available, it will be accessible at http:// www.regulations.gov and at FDA’s FSMA Web site at: http://www.fda.gov/ Food/GuidanceRegulation/FSMA/ ucm247568.htm. It may also be viewed at the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. A transcript will also be available in either hardcopy or on CD–ROM, after submission of a Freedom of Information request. Written requests are to be sent to the Division VerDate Sep<11>2014 16:37 Oct 22, 2014 Jkt 235001 of Freedom of Information (ELEM– 1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857. Additionally, FDA will be live Webcasting the event. When available, the Webcast video recording of the public meeting will be accessible at FDA’s FSMA Web site at http://www.fda.gov/Food/ GuidanceRegulation/FSMA/ ucm247568.htm. Dated: October 20, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–25261 Filed 10–22–14; 8:45 am] BILLING CODE 4164–01–P PO 00000 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. Request for comment on draft guidance. ACTION: 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 SUMMARY: Frm 00013 Fmt 4702 Sfmt 4702 E:\FR\FM\23OCP1.SGM 23OCP1 Federal Register / Vol. 79, No. 205 / Thursday, October 23, 2014 / Proposed Rules 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: mstockstill on DSK4VPTVN1PROD with PROPOSALS 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). VerDate Sep<11>2014 16:37 Oct 22, 2014 Jkt 235001 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/BiologicsBlood Vaccines/GuidanceCompliance RegulatoryInformation/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 PO 00000 Frm 00014 Fmt 4702 Sfmt 4702 63349 ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA–R09–OAR–2012–0542; FRL–9917–76– Region 9] Revisions to the California State Implementation Plan; Imperial County; Ozone Precursor Emissions Inventories Environmental Protection Agency. ACTION: Proposed rule. AGENCY: The Environmental Protection Agency (EPA) is proposing to approve a revision to the Imperial County portion of the California State Implementation Plan (SIP). This revision concerns Clean Air Act (CAA) requirements for volatile organic compounds and oxides of nitrogen emissions inventories in areas designated nonattainment for the 1997 8-hour ozone National Ambient Air Quality Standard (NAAQS). We are proposing to approve the 2002 volatile organic compound and oxides of nitrogen emissions inventories as submitted by Imperial County and California. SUMMARY: Any comments on this proposal must arrive by November 24, 2014. ADDRESSES: Submit comments, identified by docket number EPA–R09– OAR–2012–0542, by one of the following methods: 1. Federal eRulemaking Portal: www.regulations.gov. Follow the on-line instructions. 2. Email: wamsley.jerry@epa.gov. 3. Mail or deliver: Jerry Wamsley (Air2), U.S. Environmental Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA 94105–3901. Instructions: All comments will be included in the public docket without change and may be made available online at www.regulations.gov, including any personal information provided, unless the comment includes Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Information that you consider CBI or otherwise protected should be clearly identified as such and should not be submitted through www.regulations.gov or email. www.regulations.gov is an ‘‘anonymous access’’ system, and EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send email directly to EPA, your email address will be automatically captured and included as part of the public comment. If EPA cannot read your comment due to DATES: E:\FR\FM\23OCP1.SGM 23OCP1

Agencies

[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]


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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