Agency Information Collection Activities: Submission for OMB Review; Comment Request, 24317 [E7-8379]

Download as PDF 24317 Federal Register / Vol. 72, No. 84 / Wednesday, May 2, 2007 / Notices As explained in detail in the guidance, there have been repeated instances of DEG poisoning that have led to the development of this guidance. Between 1990 and 1998, DEG poisoning has been reported in Haiti, Argentina, Bangladesh, India, and Nigeria. More recently, in October 2006, there were cases of illness and death in Panama due to DEG poisoning. The cases involving DEG contamination reveal the following similarities: <bullet≤ The pharmaceutical manufacturers did not perform full identity testing on the glycerin raw material, including tests to quantify the amount of DEG present and to verify the purity of the glycerin received. <bullet≤ The pharmaceutical manufacturers of the contaminated products relied on the certificate of analysis (COA) provided by the supplier. <bullet≤ The origin of the product was not easily apparent from the COA. FDA has no reason to believe that the U.S. supply of glycerin is affected at the present time. However, because of the serious nature of this potentially fatal problem and the global nature of the pharmaceutical supply chain, FDA is emphasizing in this guidance the importance of testing glycerin for DEG. We are issuing this level 1 guidance for immediate implementation, consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The agency is not seeking comment prior to implementing this guidance because of the potential for a serious public health impact if DEGcontaminated glycerin were to enter the domestic market. The guidance represents the agency’s current thinking on this issue. 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) written or electronic comments on the guidance. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one copy. Comments are to be identified 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. Electronic Access Persons with access to the Internet may obtain the document at either http://www.fda.gov/cder/guidance/ index.htm or http://www.fda.gov/ ohrms/dockets/default.htm. Dated: April 16, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–8389 Filed 5–1–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Health Resources and Services Administration (HRSA) Number of respondents Type of report Responses per respondent publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, call the HRSA Reports Clearance Office on (301) 443–1129. The following request has been submitted to the OMB for review under the Paperwork Reduction Act of 1995: Proposed Project: Bureau of Primary Health Care (BPHC) Uniform Data System (OMB No. 0915–0193)— Extension for 2007 UDS Data Collection The Uniform Data System (UDS) contains the annual reporting requirements for the cluster of primary care grantees funded by HRSA. The UDS includes reporting requirements for grantees of the following primary care programs: Community Health Centers, Migrant Health Centers, Health Care for the Homeless, Public Housing Primary Care, and other grantees under Section 330. The authorizing statute is Section 330 of the Public Health Service Act, as amended. HRSA collects data in the UDS which is used to ensure compliance with legislative mandates and to report to Congress and policy makers on program accomplishments. To meet these objectives, HRSA requires a core set of data collected annually that is appropriate for monitoring and evaluating performance and reporting on annual trends. Estimates of annualized reporting burden are as follows: Total responses Hours per response Total burden hours 1,055 145 1 1 1,055 145 28 18 29,540 2,610 Total .............................................................................. mmaher on DSK3CLS3C1PROD with $$_JOB Universal Report .................................................................. Grant Report ........................................................................ 1,055 ........................ 1,100 ........................ 32,150 Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to: Karen Matsuoka, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503. Dated: April 25, 2007. Caroline Lewis, Acting Associate Administrator for Administration and Financial Management. [FR Doc. E7–8379 Filed 5–1–07; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing National Institutes of Health, Public Health Service, HHS. AGENCY: ACTION: VerDate Mar 15 2010 03:08 Aug 19, 2011 Jkt 223001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FEDREG\02MYN1.LOC Notice. 02MYN1

Agencies

[Federal Register Volume 72, Number 84 (Wednesday, May 2, 2007)]
[Notices]
[Page 24317]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-8379]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

    Periodically, the Health Resources and Services Administration 
(HRSA) publishes abstracts of information collection requests under 
review by the Office of Management and Budget (OMB), in compliance with 
the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request 
a copy of the clearance requests submitted to OMB for review, call the 
HRSA Reports Clearance Office on (301) 443-1129.
    The following request has been submitted to the OMB for review 
under the Paperwork Reduction Act of 1995:

Proposed Project: Bureau of Primary Health Care (BPHC) Uniform Data 
System (OMB No. 0915-0193)--Extension for 2007 UDS Data Collection

    The Uniform Data System (UDS) contains the annual reporting 
requirements for the cluster of primary care grantees funded by HRSA. 
The UDS includes reporting requirements for grantees of the following 
primary care programs: Community Health Centers, Migrant Health 
Centers, Health Care for the Homeless, Public Housing Primary Care, and 
other grantees under Section 330. The authorizing statute is Section 
330 of the Public Health Service Act, as amended.
    HRSA collects data in the UDS which is used to ensure compliance 
with legislative mandates and to report to Congress and policy makers 
on program accomplishments. To meet these objectives, HRSA requires a 
core set of data collected annually that is appropriate for monitoring 
and evaluating performance and reporting on annual trends.
    Estimates of annualized reporting burden are as follows:

----------------------------------------------------------------------------------------------------------------
                                     Number of     Responses per       Total         Hours per     Total burden
         Type of report             respondents     respondent       responses       response          hours
----------------------------------------------------------------------------------------------------------------
Universal Report................           1,055               1           1,055              28          29,540
Grant Report....................             145               1             145              18           2,610
                                 -------------------------------------------------------------------------------
    Total.......................           1,055  ..............           1,100  ..............          32,150
----------------------------------------------------------------------------------------------------------------

    Written comments and recommendations concerning the proposed 
information collection should be sent within 30 days of this notice to: 
Karen Matsuoka, Human Resources and Housing Branch, Office of 
Management and Budget, New Executive Office Building, Room 10235, 
Washington, DC 20503.

    Dated: April 25, 2007.
Caroline Lewis,
Acting Associate Administrator for Administration and Financial 
Management.
[FR Doc. E7-8379 Filed 5-1-07; 8:45 am]
BILLING CODE 4165-15-P