Draft Guidance on Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography Drugs; Availability, 60847-60848 [2011-25196]

Download as PDF 60847 Federal Register / Vol. 76, No. 190 / Friday, September 30, 2011 / Notices address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number, Room C4–26–05, 7500 Security Boulevard, Baltimore, Maryland 21244–1850. Dated: September 27, 2011. Martique Jones, Director, Regulations Development Group, Division B, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2011–25274 Filed 9–29–11; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request Proposed Projects Title: Refugee Data Submission System for Allocation of Formula Funds. OMB No.: 0970–0043. Description: The Refugee Data Submission System for Allocation of Formula Funds is designed to satisfy the statutory requirements of the Immigration and Naturalization Act (INA). Section 412(a)(3)of the Act requires that the Director of the Office of Refugee Resettlement (ORR) make a periodic assessment of the needs of refugees for assistance and services and the resources available to meet those needs. This assessment includes compiling and maintaining data on secondary migration of refugees within the United States after arrival. Further, INA 412(c)(1)(B)states that formula funds shall be allocated based on the total number of refugees in each State, taking into account secondary migration. In order to meet these statutory requirements, ORR requires each State to submit disaggregated individual records containing certain data elements for eligible populations. ORR uses the information collected through the Web site to determine secondary migration for the purposes of formula funds allocation to States. The submission of individual records via the Refugee Data Submission System for Allocation of Formula Funds is a reliable and secure process for collecting data for the purposes of tracking secondary migration and allocating formula funds. Data submitted by the States via the Web site are also compiled and analyzed for inclusion in ORR’s Annual Report to Congress. Respondents: States, Wilson/Fish Alternative Projects, and the District of Columbia. ANNUAL BURDEN ESTIMATES Number of respondents Number of responses per respondent Average burden hours per response Total burden hours Refugee Data Submission for Formula Funds Allocations ........... mstockstill on DSK4VPTVN1PROD with NOTICES Instrument 50 1 20 1,000 Estimated Total Annual Burden Hours: 1,000. 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 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 Administration, Office of Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. E-mail 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 VerDate Mar<15>2010 17:19 Sep 29, 2011 Jkt 223001 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 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. DEPARTMENT OF HEALTH AND HUMAN SERVICES Robert Sargis, Reports Clearance Officer. ACTION: PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 [Docket No. FDA–2011–D–0691] Draft Guidance on Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography Drugs; Availability AGENCY: Food and Drug Administration, HHS. Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ‘‘Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PET) Drugs.’’ This draft guidance is intended to help manufacturers of PET drugs meet the requirements for the Agency’s current good manufacturing practice regulations for PET drugs. 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 SUMMARY: [FR Doc. 2011–25210 Filed 9–29–11; 8:45 am] BILLING CODE 4184–01–P Food and Drug Administration E:\FR\FM\30SEN1.SGM 30SEN1 60848 Federal Register / Vol. 76, No. 190 / Friday, September 30, 2011 / Notices mstockstill on DSK4VPTVN1PROD with NOTICES guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by December 29, 2011. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your request. 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: Elizabeth Giaquinto, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6155, Silver Spring, MD 20993–0002, 301– 796–3416. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance entitled ‘‘Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PET) Drugs.’’ Most PET drugs are designed for parenteral administration and are produced by aseptic processing. The goal of aseptic processing is to make a product that is free of microorganisms and toxic microbial byproducts, most notably bacterial endotoxins. The media fill is the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium in place of the drug solution to test whether the aseptic procedures are adequate to prevent contamination during actual drug production. This draft guidance takes the form of questions and answers written specifically to help manufacturers comply with the Agency’s current good manufacturing practices for PET drugs (part 212 (21 CFR part 212)) regarding media fills. 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 Agency’s current thinking on media fills and process simulations for PET drugs. It does not create or confer any rights for or on any person VerDate Mar<15>2010 17:19 Sep 29, 2011 Jkt 223001 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. II. 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. III. 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 part 212 have been approved under OMB control number 0910–0667. IV. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. Dated: September 26, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–25196 Filed 9–29–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0002] National Mammography Quality Assurance Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. 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. PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 Name of Committee: National Mammography Quality Assurance Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on November 4, 2011, from 8 a.m. to 6 p.m. Location: Holiday Inn, Ballroom, 2 Montgomery Village Ave, Gaithersburg, MD 20879. The hotel’s telephone number is 301–948–8900. Contact Person: Shanika Craig, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301–796–6639, Shanika.Craig@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: On November 4, 2011, the committee will provide advice and recommendations on the following issues: (1) Proposed changes to the Mammography Quality Standard Act (MQSA) policies and inspection procedures; (2) accreditation body review of soft copy mammography images; and (3) reporting breast density on mammography reports and patient lay summaries. The committee will also receive updates on the MQSA program and the status of the Full Field Digital Mammography universal quality control manual. FDA intends to make background material available to the public no later than 2 business days before the meeting. 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 https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee link. Procedure: Interested persons may present data, information, or views, E:\FR\FM\30SEN1.SGM 30SEN1

Agencies

[Federal Register Volume 76, Number 190 (Friday, September 30, 2011)]
[Notices]
[Pages 60847-60848]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-25196]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0691]


Draft Guidance on Media Fills for Validation of Aseptic 
Preparations for Positron Emission Tomography Drugs; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance entitled ``Media Fills for Validation 
of Aseptic Preparations for Positron Emission Tomography (PET) Drugs.'' 
This draft guidance is intended to help manufacturers of PET drugs meet 
the requirements for the Agency's current good manufacturing practice 
regulations for PET drugs.

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

[[Page 60848]]

guidance before it begins work on the final version of the guidance, 
submit either electronic or written comments on the draft guidance by 
December 29, 2011.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your request. 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: Elizabeth Giaquinto, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6155, Silver Spring, MD 20993-0002, 301-
796-3416.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance entitled 
``Media Fills for Validation of Aseptic Preparations for Positron 
Emission Tomography (PET) Drugs.'' Most PET drugs are designed for 
parenteral administration and are produced by aseptic processing. The 
goal of aseptic processing is to make a product that is free of micro-
organisms and toxic microbial byproducts, most notably bacterial 
endotoxins. The media fill is the performance of an aseptic 
manufacturing procedure using a sterile microbiological growth medium 
in place of the drug solution to test whether the aseptic procedures 
are adequate to prevent contamination during actual drug production. 
This draft guidance takes the form of questions and answers written 
specifically to help manufacturers comply with the Agency's current 
good manufacturing practices for PET drugs (part 212 (21 CFR part 212)) 
regarding media fills.
    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 Agency's current thinking on media fills 
and process simulations for PET drugs. 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.

II. 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.

III. 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 part 212 have been approved under OMB 
control number 0910-0667.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

    Dated: September 26, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-25196 Filed 9-29-11; 8:45 am]
BILLING CODE 4160-01-P
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