Guidance for Industry: Current Good Tissue Practice and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products; Availability, 82308-82309 [2011-33572]

Download as PDF 82308 Federal Register / Vol. 76, No. 251 / Friday, December 30, 2011 / Notices Based on FDA’s data on the number of sponsors that would be covered by the draft guidance, we estimate that approximately 180 SOPs related to histologic evaluation will include the new procedures, and that sponsors will need approximately 30 minutes to document, maintain, and update their SOPs with the new procedures. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED RECORDKEEPING BURDEN 1 Number of recordkeepers Number of records per recordkeeper Total annual records Average burden per recordkeeping (in hours) Total hours 30 6 180 0.5 90 .............................. .............................. .............................. .............................. 90 SOP New Procedures ............................ Total ................................................ 1 There are no capital costs or operating and maintenance costs associated with this information collection. IV. Electronic Access Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or http:// www.regulations.gov. Dated: December 22, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–33553 Filed 12–29–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–D–0659] Guidance for Industry: Current Good Tissue Practice and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a document entitled ‘‘Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)’’ dated December 2011. The guidance document provides recommendations to establishments for complying with CGTP and additional requirements for manufacturers of HCT/Ps. The guidance is intended for any HCT/P establishment that performs a manufacturing step and is responsible for complying with CGTP requirements. The guidance also addresses whether the establishment registration and HCT/ P listing requirements apply in certain instances. The guidance announced in srobinson on DSK4SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 19:02 Dec 29, 2011 Jkt 226001 this notice finalizes the draft guidance of the same title dated January 2009. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written requests for single copies of the guidance to the Office of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448. Send one self-addressed adhesive label to assist that office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1–(800) 835– 4709 or (301) 827–1800. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments on the 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 Jo Churchyard, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, (301) 827–6210. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a document entitled ‘‘Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)’’ dated December 2011. The guidance provides recommendations for complying with the CGTP requirements under part 1271 (21 CFR part 1271), subpart D, and additional requirements for manufacturers of HCT/Ps under part 1271, subpart E. The guidance is intended for any HCT/P establishment PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 that performs a manufacturing step and is responsible for complying with CGTP requirements. However, at this time, part 1271, subpart D (with the exceptions of §§ 1271.150(c) and 1271.155) and subpart E do not apply to reproductive HCT/P establishments regulated solely under section 361 of the Public Health Service Act (42 U.S.C. 264) (the PHS Act). In consideration of the input FDA received from stakeholders, this guidance provides recommendations for establishments that manufacture HCT/Ps that meet the criteria listed in § 1271.10 and are regulated solely under section 361 of the PHS Act and the regulations in part 1271. CGTP requirements also apply to HCT/Ps regulated as drugs, devices, and/or biological products under section 351 of the PHS Act (42 U.S.C. 262) and/or the Federal Food, Drug, and Cosmetic Act (see § 1271.1(b)(2)). The guidance also addresses whether the establishment registration and HCT/P listing requirements under part 1271, subparts A and B, apply in certain instances. In the Federal Register of January 16, 2009 (74 FR 3055), FDA announced the availability of the draft guidance of the same title dated January 2009. FDA received numerous comments on the draft guidance, and those comments were considered as the guidance was finalized. In addition, editorial changes were made to improve clarity. The guidance announced in this notice finalizes the draft guidance dated January 2009. The guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents 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 requirements of the applicable statutes and regulations. E:\FR\FM\30DEN1.SGM 30DEN1 Federal Register / Vol. 76, No. 251 / Friday, December 30, 2011 / Notices II. Paperwork Reduction Act of 1995 The 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, and the collections of information in 21 CFR part 820 have been approved under OMB control number 0910–0073. III. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed 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. IV. Electronic Access Persons with access to the Internet may obtain the guidance at either http:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/default.htm or http://www.regulations.gov. Dated: December 15, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–33572 Filed 12–29–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0002] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. srobinson on DSK4SPTVN1PROD with NOTICES ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Oncologic Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. VerDate Mar<15>2010 19:02 Dec 29, 2011 Jkt 226001 Date and Time: The meeting will be held on February 9, 2012, from 8 a.m. to 5 p.m. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993– 0002. Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/ AdvisoryCommittees/default.htm; under the heading ‘‘Resources for You,’’ click on ‘‘Public Meetings at the FDA White Oak Campus.’’ Please note that visitors to the White Oak Campus must enter through Building 1. Contact Person: Caleb Briggs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 2417, Silver Spring, MD 20993–0002, (301) 796–9001, FAX: (301) 847–8533, email: ODAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–(800) 741–8138; (301) 443–0572 in the Washington, DC area), and follow the prompts to the desired center or product area. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: During the morning session, the committee will discuss supplemental new drug application (NDA) 21790/010 for DACOGEN (decitabine) for injection, application submitted by Eisai, Inc. The proposed indication (use) for this product is for the treatment of acute myelogenous leukemia (AML) in adults 65 years of age or older who are not considered candidates for induction chemotherapy, which is the standard first phase of treatment for AML. During the afternoon session, the committee will discuss NDA 022481, with the proposed trade name PIXUVRI (pixantrone dimaleate) injection, application submitted by Cell Therapeutics, Inc. The proposed indication (use) for this product is as a single agent treatment for patients with relapsed or refractory (difficult to treat), aggressive Non-Hodgkin’s Lymphoma who received two or more prior lines of therapy. FDA intends to make background material available to the public no later than 2 business days before the meeting. PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 82309 If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at http://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before January 25, 2012. Oral presentations from the public will be scheduled between approximately 10:30 a.m. to 11 a.m., and 3:30 p.m. to 4 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before January 17, 2012. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by January 18, 2012. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Caleb Briggs at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/Advisory Committees/AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). E:\FR\FM\30DEN1.SGM 30DEN1

Agencies

[Federal Register Volume 76, Number 251 (Friday, December 30, 2011)]
[Notices]
[Pages 82308-82309]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-33572]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0659]


Guidance for Industry: Current Good Tissue Practice and 
Additional Requirements for Manufacturers of Human Cells, Tissues, and 
Cellular and Tissue-Based Products; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a document entitled ``Guidance for Industry: Current 
Good Tissue Practice (CGTP) and Additional Requirements for 
Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based 
Products (HCT/Ps)'' dated December 2011. The guidance document provides 
recommendations to establishments for complying with CGTP and 
additional requirements for manufacturers of HCT/Ps. The guidance is 
intended for any HCT/P establishment that performs a manufacturing step 
and is responsible for complying with CGTP requirements. The guidance 
also addresses whether the establishment registration and HCT/P listing 
requirements apply in certain instances. The guidance announced in this 
notice finalizes the draft guidance of the same title dated January 
2009.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Office of Communication, Outreach and Development (HFM-40), Center 
for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist that office in 
processing your requests. The guidance may also be obtained by mail by 
calling CBER at 1-(800) 835-4709 or (301) 827-1800. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the guidance 
document.
    Submit electronic comments on the 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 Jo Churchyard, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, (301) 827-6210.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a document entitled 
``Guidance for Industry: Current Good Tissue Practice (CGTP) and 
Additional Requirements for Manufacturers of Human Cells, Tissues, and 
Cellular and Tissue-Based Products (HCT/Ps)'' dated December 2011. The 
guidance provides recommendations for complying with the CGTP 
requirements under part 1271 (21 CFR part 1271), subpart D, and 
additional requirements for manufacturers of HCT/Ps under part 1271, 
subpart E. The guidance is intended for any HCT/P establishment that 
performs a manufacturing step and is responsible for complying with 
CGTP requirements. However, at this time, part 1271, subpart D (with 
the exceptions of Sec. Sec.  1271.150(c) and 1271.155) and subpart E do 
not apply to reproductive HCT/P establishments regulated solely under 
section 361 of the Public Health Service Act (42 U.S.C. 264) (the PHS 
Act). In consideration of the input FDA received from stakeholders, 
this guidance provides recommendations for establishments that 
manufacture HCT/Ps that meet the criteria listed in Sec.  1271.10 and 
are regulated solely under section 361 of the PHS Act and the 
regulations in part 1271. CGTP requirements also apply to HCT/Ps 
regulated as drugs, devices, and/or biological products under section 
351 of the PHS Act (42 U.S.C. 262) and/or the Federal Food, Drug, and 
Cosmetic Act (see Sec.  1271.1(b)(2)). The guidance also addresses 
whether the establishment registration and HCT/P listing requirements 
under part 1271, subparts A and B, apply in certain instances.
    In the Federal Register of January 16, 2009 (74 FR 3055), FDA 
announced the availability of the draft guidance of the same title 
dated January 2009. FDA received numerous comments on the draft 
guidance, and those comments were considered as the guidance was 
finalized. In addition, editorial changes were made to improve clarity. 
The guidance announced in this notice finalizes the draft guidance 
dated January 2009.
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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 
requirements of the applicable statutes and regulations.

[[Page 82309]]

II. Paperwork Reduction Act of 1995

    The 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, and the collections of information in 21 
CFR part 820 have been approved under OMB control number 0910-0073.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed 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.

IV. Electronic Access

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

    Dated: December 15, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-33572 Filed 12-29-11; 8:45 am]
BILLING CODE 4160-01-P