Guidance for Small Business Entities on Current Good Manufacturing Practice for Positron Emission Tomography Drugs; Availability, 47593-47594 [2011-19867]

Download as PDF erowe on DSKG8SOYB1PROD with NOTICES Federal Register / Vol. 76, No. 151 / Friday, August 5, 2011 / Notices minimize the information collection burden. 1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: State Collection and Reporting of Dental Provider and Benefit Package Information on the Insure Kids Now! Web site and Hotline; Use: The Children’s Health Insurance Program Reauthorization Act of 2009 (CHIPRA) sections 501(f)(1) and (2), requires that state-specific information on dental providers and benefits be posted on the Insure Kids Now (IKN) Web site and available on the hotline. States must update the information on the dental providers quarterly and the information on their benefit package annually. CMS is asking States to submit their dental benefits in a revised format that is designed to reduce the amount of time States have to spend in compiling the dental benefit information. Although in the past we allowed States to only check a box to indicate that the Medicaid dental benefits were in compliance with Early and Periodic Screening, Diagnostic and Treatment (EPSDT) services, we are also modifying the form to ask States to include their Medicaid dental benefits in this form so those may also be posted on the Web site. In addition, we are asking States to specify if they have a dollar or code limit at which point prior authorization is required for any additional services and if they have cost sharing requirements for dental services; Form Number: CMS–10291 (OMB #: 0938–1065); Frequency: Yearly (dental benefits) and quarterly (dental providers); Affected Public: State, Local, or Tribal Governments; Number of Respondents: 51; Total Annual Responses: 255; Total Annual Hours: 190. (For policy questions regarding this collection contact Nancy Goetschius at 410–786–0707. For all other issues call 410–786–1326.) To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS’ Web site address at https://www.cms.hhs.gov/ PaperworkReductionActof1995, or email your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov, or call the Reports Clearance Office on (410) 786– 1326. In commenting on the proposed information collections please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in one of the following ways by October 4, 2011: VerDate Mar<15>2010 15:16 Aug 04, 2011 Jkt 223001 1. Electronically. You may submit your comments electronically to https:// www.regulations.gov. Follow the instructions for ‘‘Comment or Submission’’ or ‘‘More Search Options’’ to find the information collection document(s) accepting comments. 2. By regular mail. You may mail written comments to the following 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: August 1, 2011. Martique Jones, Director, Regulations Development Group, Division B, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2011–19768 Filed 8–4–11; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES 47593 Preventive Health grant. Services provided under the grant to Lutheran Social Services of North Dakota are within the scope and operation of the original award, and address the preventive health needs of refugees in their first year in the United States. The program includes initial health screening, treatment of immediate health needs, follow up on chronic illnesses, nursing case management, interpretation services and preventive health education. The project period for the award is July 1, 2010 to June 30, 2011. FOR FURTHER INFORMATION CONTACT: Pamela Green-Smith, Director, Division of Refugee Assistance, Office of Refugee Resettlement, 370 L’Enfant Promenade, SW., Washington, DC 20447. Telephone: 202–401–4531. E-mail: Pamela.Greensmith@acf.hhs.gov. Dated: July 27, 2011. Mitiku Ashebir, Acting Director, Division of Refugee Assistance, Office of Refugee Resettlement. [FR Doc. 2011–19847 Filed 8–4–11; 8:45 am] Administration for Children and Families BILLING CODE 4120–27–P Award of Replacement Grant for Preventive Health to Lutheran Social Services of North Dakota, Fargo, ND DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of Refugee Resettlement, ACF, DHHS. ACTION: Notice of award. AGENCY: CFDA NUMBER: 93.576. Statutory Authority: This program is authorized by Section 412(b)(5) of the Immigration and Nationality Act, as amended (8 U.S.C. 1522(b)(5)), which provides for medical screening and initial medical treatment for refugees. Amount of Award: $66,000. SUMMARY: In Fiscal Year 2006, in an effort to assist States and local health departments to ensure that newly arriving refugees have access to preventive health screenings, the Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR), Division of Refugee Assistance (DRA) awarded, through competition, a Refugee Preventive Health grant to the North Dakota Department of Human Services for a project period of July 1, 2006 to June 30, 2011. The North Dakota Department of Human Services has relinquished the grant. ORR announces the award of a singlesource replacement grant to Lutheran Social Services of North Dakota of Fargo, ND, a non-profit organization engaged in the resettlement of refugees, to continue services under the Refugee PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 Food and Drug Administration [Docket No. FDA–2011–D–0541] Guidance for Small Business Entities on Current Good Manufacturing Practice for Positron Emission Tomography Drugs; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a guidance for small business entities entitled ‘‘PET Drugs— Current Good Manufacturing Practice (CGMP); Small Entity Compliance Guide.’’ FDA has prepared this guidance in accordance with the Small Business Regulatory Enforcement Fairness Act. It is intended to help small businesses better understand FDA’s thinking on compliance with the positron emission tomography drugs (PET) CGMP regulations, including appropriate resources, procedures, and documentation for PET drug production facilities. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written requests for single copies of this guidance to the Division of Drug Information, Center for SUMMARY: E:\FR\FM\05AUN1.SGM 05AUN1 47594 Federal Register / Vol. 76, No. 151 / Friday, August 5, 2011 / Notices 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 requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments on the 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: Frank Perrella, Center for Drug Evaluation and Research (HFD–320), Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301–796–3265. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance entitled ‘‘PET Drugs— Current Good Manufacturing Practice (CGMP); Small Entity Compliance Guide.’’ This guidance is intended to help small businesses better understand and comply with the regulations issued by FDA concerning CGMP for PET drugs. The guidance addresses resources, procedures, and documentation for all PET drug production facilities. In some cases, the guidance provides practical examples of methods or procedures that PET drug production facilities can use to comply with the CGMP requirements. FDA has prepared this guidance in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency’s current thinking on compliance with CGMP 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 erowe on DSKG8SOYB1PROD with NOTICES 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 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 211 have been approved under OMB control number 0910–0139, and the collections of information in 21 CFR 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: August 1, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–19867 Filed 8–4–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [Billing Code 4140–01–P] National Institutes of Health; Proposed Collection; Comment Request; Simulations for Drug Related Science Education Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute on Drug Abuse (NIDA), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously SUMMARY: Number of respondents Type of respondents published in the Federal Register on June 26, 2008 (Vol. 73, No. 124, page 36337) and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after November 15, 2008, unless it displays a currently valid OMB control number. Proposed Collection: Title: Simulations for Drug Related Science Education. Type of Information Collection Request: NEW. Need and Use of Information Collection: This is a request for a one-time clearance to evaluate an interactive multimedia module developed by ArchieMD. This evaluation seeks to determine whether the multimedia module Archie MD: The Science of Drugs (1) Increases students’ knowledge in brain and heart biology and the effects drugs have on the body (2) Increases positive attitudes towards science education for high school students (3) Reinforce or instill negative attitudes towards substance abuse. In order to test the effectiveness of the interactive multimedia module, data will be collected in the form of pre and post test surveys from 10th and 11th grade high school students utilizing the developed module. The findings will provide valuable information regarding information pertaining to the use of interactive multimedia educational modules in high school science classrooms and their ability to increase knowledge and change attitudes and perceptions. Frequency of Response: 3. Affected Public: High school students engaged with the ArchieMD: The Science of Drugs program. Type of Respondent: Participants will include high school students enrolled in the tenth and eleventh grade. Estimated Total Annual Number of Respondents: 360. Estimated Number of Responses per Respondent: 4. Average Burden Hours per Response: 25 minutes. Estimated Total Annual Burden Hours Requested: 450.00. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. The estimated annualized burden is summarized below. Frequency of response Average burden hours per response Estimated total burden hours requested Participants-High School Students .................................................................. 360 3 .417 450.00 Total .......................................................................................................... 360 3 .417 450.00 VerDate Mar<15>2010 17:18 Aug 04, 2011 Jkt 223001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\05AUN1.SGM 05AUN1

Agencies

[Federal Register Volume 76, Number 151 (Friday, August 5, 2011)]
[Notices]
[Pages 47593-47594]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19867]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0541]


Guidance for Small Business Entities on Current Good 
Manufacturing Practice 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 guidance for small business entities entitled ``PET 
Drugs--Current Good Manufacturing Practice (CGMP); Small Entity 
Compliance Guide.'' FDA has prepared this guidance in accordance with 
the Small Business Regulatory Enforcement Fairness Act. It is intended 
to help small businesses better understand FDA's thinking on compliance 
with the positron emission tomography drugs (PET) CGMP regulations, 
including appropriate resources, procedures, and documentation for PET 
drug production facilities.

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

ADDRESSES: Submit written requests for single copies of this guidance 
to the Division of Drug Information, Center for

[[Page 47594]]

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 requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.
    Submit electronic comments on the 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: Frank Perrella, Center for Drug 
Evaluation and Research (HFD-320), Food and Drug Administration, 10903 
New Hampshire Ave., Silver Spring, MD 20993, 301-796-3265.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance entitled ``PET 
Drugs--Current Good Manufacturing Practice (CGMP); Small Entity 
Compliance Guide.'' This guidance is intended to help small businesses 
better understand and comply with the regulations issued by FDA 
concerning CGMP for PET drugs. The guidance addresses resources, 
procedures, and documentation for all PET drug production facilities. 
In some cases, the guidance provides practical examples of methods or 
procedures that PET drug production facilities can use to comply with 
the CGMP requirements. FDA has prepared this guidance in accordance 
with section 212 of the Small Business Regulatory Enforcement Fairness 
Act.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on compliance with CGMP 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 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 211 have been approved under 
OMB control number 0910-0139, and the collections of information in 21 
CFR 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: August 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-19867 Filed 8-4-11; 8:45 am]
BILLING CODE 4160-01-P
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