Draft Guidance for Industry: Biologics License Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients With Disorders Affecting the Hematopoietic System; Availability, 36196-36197 [2013-14097]

Download as PDF 36196 Federal Register / Vol. 78, No. 116 / Monday, June 17, 2013 / Notices Dated: June 10, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–14096 Filed 6–14–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2006–D–0157] Draft Guidance for Industry: Biologics License Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients With Disorders Affecting the Hematopoietic System; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ‘‘Guidance for Industry: Biologics License Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System’’ dated June 2013. The draft guidance document provides recommendations for manufacturers, generally cord blood banks, to apply for licensure of minimally manipulated, unrelated allogeneic placental/umbilical cord blood, for hematopoietic and immunologic reconstitution. The guidance document is intended to assist manufacturers obtain a biologics license. The guidance contains information about the manufacture of minimally manipulated, unrelated allogeneic placental/umbilical cord blood and how to comply with applicable regulatory requirements. The draft guidance, when finalized, is intended to supersede the guidance entitled ‘‘Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications’’ dated October 2009. 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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 20:38 Jun 14, 2013 Jkt 229001 on the draft guidance by September 16, 2013. ADDRESSES: Submit written requests for single copies of the draft 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 the office in processing your requests. The draft 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 draft guidance document. Submit electronic comments on the draft guidance to https:// 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: Valerie A. Butler, 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 draft document entitled ‘‘Guidance for Industry: Biologics License Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System’’ dated June 2013. The draft guidance document, when finalized, will provide recommendations for manufacturers to apply for licensure of minimally manipulated, unrelated allogeneic placental/umbilical cord blood, for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment. The guidance document is intended to assist manufacturers obtain a biologics license. The guidance contains information about the manufacture of minimally manipulated, unrelated, allogeneic placental/umbilical cord blood and how to comply with applicable regulatory requirements. The draft guidance, when finalized, is intended to supersede the document entitled ‘‘Guidance for Industry: Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 Reconstitution for Specified Indications’’ dated October 2009. 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. Elsewhere in this issue of the Federal Register, we also are announcing the availability of another, related draft guidance entitled ‘‘Guidance for Industry and FDA Staff: Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System.’’ That draft guidance, when finalized, is intended to supersede the document entitled ‘‘Guidance for Industry and FDA Staff: Investigational New Drug Applications (INDs) for Minimally Manipulated, Unrelated Allogeneic Placental/ Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications’’ dated June 2011. 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 201 have been approved under OMB control number 0910–0572; 21 CFR part 211 have been approved under OMB control number 0910–0139; 21 CFR part 600 have been approved under OMB control number 0910–0308; 21 CFR parts 601, 610, and FDA Form 356h have been approved under OMB control number 0910–0338; 21 CFR part 1271 have been approved under OMB control number 0910–0543; and FDA Form 3500A has been approved under OMB control number 0910–0291. 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 https:// www.regulations.gov or written comments to the Division of Dockets E:\FR\FM\17JNN1.SGM 17JNN1 Federal Register / Vol. 78, No. 116 / Monday, June 17, 2013 / Notices 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 https:// www.regulations.gov. 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. Dated: June 10, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–14097 Filed 6–14–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service [OMB Control Number 0917–0006] Request for Public Comment: 60-Day Proposed Information Collection: Application for Participation in the IHS Scholarship Program AGENCY: Indian Health Service. In compliance with Section 3506 (c)(2)(A) of the Paperwork Reduction Act of 1995 which requires 60-days advance opportunity for public comment on proposed information collection projects, the Indian Health Service (IHS) is publishing for comment a summary of a proposed information collection to be submitted to the Office of Management and Budget (OMB) for review. Proposed Collection: Title: 0917– 0006, ‘‘Application for Participation in the IHS Scholarship Program.’’ Type of Information Collection Request: Three year extension of the currently approved information collection, 0917–0006, ‘‘Application for Participation in the IHS Scholarship Program.’’ Form Number(s): IHS–856–3, IHS–856–5 through 856–19, IHS–856–21 through 856–24, IHS–817, and IHS–818 are retained for use by the IHS Scholarship Program (IHSSP) as part of this current Information Collection Request. Reporting forms are found on the IHS Web site at www.ihs.gov/scholarship. Form Numbers: IHS–856, IHS–856–2, IHS–856–4, IHS–856–20, IHS–815, and IHS–816 have been deleted from the previous Information Collection Request in an effort to comply with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). Need and Use of Information Collection: The IHS Scholarship Branch SUMMARY: Faculty/Employer Evaluation (IHS–856–3) ...... Delinquent Federal Debt (IHS–856–5) ............ Course Curriculum Verification (IHS–856–6) .. Verification of Acceptance or Decline of Award (IHS–856–7). Recipient’s Initial Program Progress Report (IHS–856–8). Notification of Academic Problem (IHS–856– 9). Change of Status (IHS–856–10) ..................... Request for Approval of Deferment (IHS– 856–11). Preferred Placement (IHS–856–12) ................ Notice of Impending Graduation (IHS–856– 13). Notification of Deferment Program (IHS–856– 14). Placement Update (IHS–856–15) ................... Annual Status Report (IHS–856–16) ............... Extern Site Preference Request (IHS–856– 17). Request for Extern Travel Reimbursement (IHS–856–18). Lost Stipend Payment (IHS–856–19) .............. Summer School Request (IHS–856–21) ......... Change of Name or Address (IHS–856–22) ... Request for Credit Validation (IHS–856–23) ... Faculty/Advisor Evaluation (IHS–856–24) ....... Scholarship Program Agreement (IHS–817) ... VerDate Mar<15>2010 20:38 Jun 14, 2013 Jkt 229001 Notice. Number of respondents Data collection instrument(s) mstockstill on DSK4VPTVN1PROD with NOTICES ACTION: PO 00000 Responses per respondent 36197 needs this information for program administration and uses the information to: solicit, process, and award IHS Pregraduate, Preparatory, and/or Health Professions Scholarship recipients; monitor the academic performance of recipients; and to place recipients at payback sites. The IHS Scholarship Program streamlined the application process by converting the IHS–856 to an electronic tool and reduced the number of required supplemental application and reporting forms to minimize the time needed by applicants and recipients to complete the application process and provide required information after receiving a scholarship from the IHSSP. The IHSSP application is electronically available on the internet at the IHS Web site at: https:// www.ihs.gov/scholarship/ apply_now.cfm. Affected Public: Individuals, not-forprofit institutions and State, local or Tribal Governments. Type of Respondents: Students pursuing health care professions. The table below provides: Types of data collection instruments, Estimated number of respondents, Number of responses per respondent, Annual number of responses, Average burden hour per response, and Total annual burden hours. Total annual response Burden hour per response* Annual burden hours 1500 1500 1500 500 2 1 1 1 3000 1500 1500 500 0.42 0.13 0.70 0.13 (25 min) ..................... ( 8 min) ...................... (42 min) ..................... ( 8 min) ...................... 1250 200 1050 67 1200 1 1200 0.13 ( 8 min) ...................... 160 50 1 50 0.13 ( 8 min) ...................... 7 50 20 1 1 50 20 .045 (25 min) ..................... 0.13 ( 8 min) ...................... 21 3 150 170 1 1 150 170 0.50 (30 min) ..................... 0.17 (10 min) ..................... 75 28 20 1 20 0.13 (8 min) ....................... 3 170 200 300 1 1 1 170 200 300 0.18 (11 min) ..................... 0.25 (15 min) ..................... 0.13 ( 8 min) ...................... 31 50 40 150 1 150 0.10 ( 6 min) ...................... 15 50 100 20 30 1500 175 1 1 1 1 2 1 50 100 20 30 3000 175 Frm 00038 Fmt 4703 Sfmt 4703 0.13 0.10 0.13 0.10 0.42 0.16 E:\FR\FM\17JNN1.SGM ( 8 min) ...................... ( 6 min) ...................... (8 min) ....................... (6 min) ....................... (25 min) ..................... (10 min) ..................... 17JNN1 7 10 3 3 1250 29

Agencies

[Federal Register Volume 78, Number 116 (Monday, June 17, 2013)]
[Notices]
[Pages 36196-36197]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-14097]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2006-D-0157]


Draft Guidance for Industry: Biologics License Applications for 
Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord 
Blood Intended for Hematopoietic and Immunologic Reconstitution in 
Patients With Disorders Affecting the Hematopoietic System; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft document entitled ``Guidance for Industry: 
Biologics License Applications for Minimally Manipulated, Unrelated 
Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic 
and Immunologic Reconstitution in Patients with Disorders Affecting the 
Hematopoietic System'' dated June 2013. The draft guidance document 
provides recommendations for manufacturers, generally cord blood banks, 
to apply for licensure of minimally manipulated, unrelated allogeneic 
placental/umbilical cord blood, for hematopoietic and immunologic 
reconstitution. The guidance document is intended to assist 
manufacturers obtain a biologics license. The guidance contains 
information about the manufacture of minimally manipulated, unrelated 
allogeneic placental/umbilical cord blood and how to comply with 
applicable regulatory requirements. The draft guidance, when finalized, 
is intended to supersede the guidance entitled ``Guidance for Industry: 
Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord 
Blood Intended for Hematopoietic Reconstitution for Specified 
Indications'' dated October 2009.

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 September 16, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
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 the office in 
processing your requests. The draft 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 draft 
guidance document.
    Submit electronic comments on the draft guidance to https://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: Valerie A. Butler, 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 draft document entitled 
``Guidance for Industry: Biologics License Applications for Minimally 
Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood 
Intended for Hematopoietic and Immunologic Reconstitution in Patients 
with Disorders Affecting the Hematopoietic System'' dated June 2013. 
The draft guidance document, when finalized, will provide 
recommendations for manufacturers to apply for licensure of minimally 
manipulated, unrelated allogeneic placental/umbilical cord blood, for 
hematopoietic and immunologic reconstitution in patients with disorders 
affecting the hematopoietic system that are inherited, acquired, or 
result from myeloablative treatment. The guidance document is intended 
to assist manufacturers obtain a biologics license. The guidance 
contains information about the manufacture of minimally manipulated, 
unrelated, allogeneic placental/umbilical cord blood and how to comply 
with applicable regulatory requirements. The draft guidance, when 
finalized, is intended to supersede the document entitled ``Guidance 
for Industry: Minimally Manipulated, Unrelated Allogeneic Placental/
Umbilical Cord Blood Intended for Hematopoietic Reconstitution for 
Specified Indications'' dated October 2009.
    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.
    Elsewhere in this issue of the Federal Register, we also are 
announcing the availability of another, related draft guidance entitled 
``Guidance for Industry and FDA Staff: Investigational New Drug 
Applications for Minimally Manipulated, Unrelated Allogeneic Placental/
Umbilical Cord Blood Intended for Hematopoietic and Immunologic 
Reconstitution in Patients with Disorders Affecting the Hematopoietic 
System.'' That draft guidance, when finalized, is intended to supersede 
the document entitled ``Guidance for Industry and FDA Staff: 
Investigational New Drug Applications (INDs) for Minimally Manipulated, 
Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for 
Hematopoietic Reconstitution for Specified Indications'' dated June 
2011.

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 201 have been approved under 
OMB control number 0910-0572; 21 CFR part 211 have been approved under 
OMB control number 0910-0139; 21 CFR part 600 have been approved under 
OMB control number 0910-0308; 21 CFR parts 601, 610, and FDA Form 356h 
have been approved under OMB control number 0910-0338; 21 CFR part 1271 
have been approved under OMB control number 0910-0543; and FDA Form 
3500A has been approved under OMB control number 0910-0291.

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 https://www.regulations.gov or written comments to the Division of Dockets

[[Page 36197]]

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 https://www.regulations.gov.

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: June 10, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-14097 Filed 6-14-13; 8:45 am]
BILLING CODE 4160-01-P
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