Federal Register / Vol. 72, No.

84 / Wednesday, May 2, 2007 / Notices 24317

As explained in detail in the not operate to bind FDA or the public. publishes abstracts of information
guidance, there have been repeated An alternative approach may be used if collection requests under review by the
instances of DEG poisoning that have such approach satisfies the Office of Management and Budget
led to the development of this guidance. requirements of the applicable statutes (OMB), in compliance with the
Between 1990 and 1998, DEG poisoning and regulations. Paperwork Reduction Act of 1995 (44
has been reported in Haiti, Argentina, II. Comments U.S.C. Chapter 35). To request a copy of
Bangladesh, India, and Nigeria. More the clearance requests submitted to
recently, in October 2006, there were Interested persons may submit to the
OMB for review, call the HRSA Reports
cases of illness and death in Panama Division of Dockets Management (see
ADDRESSES) written or electronic
Clearance Office on (301) 443–1129.
due to DEG poisoning.
The cases involving DEG comments on the guidance. Submit a The following request has been
contamination reveal the following single copy of electronic comments or submitted to the OMB for review under
similarities: two paper copies of any mailed the Paperwork Reduction Act of 1995:
• The pharmaceutical manufacturers comments, except that individuals may
submit one copy. Comments are to be Proposed Project: Bureau of Primary
did not perform full identity testing on Health Care (BPHC) Uniform Data
the glycerin raw material, including identified with the docket number
found in brackets in the heading of this System (OMB No. 0915–0193)—
tests to quantify the amount of DEG
document. Received comments may be Extension for 2007 UDS Data Collection
present and to verify the purity of the
glycerin received. seen in the Division of Dockets
The Uniform Data System (UDS)
• The pharmaceutical manufacturers Management between 9 a.m. and 4 p.m.,
Monday through Friday. contains the annual reporting
of the contaminated products relied on requirements for the cluster of primary
the certificate of analysis (COA) III. Electronic Access care grantees funded by HRSA. The
provided by the supplier. UDS includes reporting requirements
Persons with access to the Internet
• The origin of the product was not for grantees of the following primary
may obtain the document at either
easily apparent from the COA.
http://www.fda.gov/cder/guidance/ care programs: Community Health
FDA has no reason to believe that the
index.htm or http://www.fda.gov/ Centers, Migrant Health Centers, Health
U.S. supply of glycerin is affected at the
ohrms/dockets/default.htm. Care for the Homeless, Public Housing
present time. However, because of the
serious nature of this potentially fatal Dated: April 16, 2007. Primary Care, and other grantees under
problem and the global nature of the Jeffrey Shuren, Section 330. The authorizing statute is
pharmaceutical supply chain, FDA is Assistant Commissioner for Policy. Section 330 of the Public Health Service
emphasizing in this guidance the [FR Doc. E7–8389 Filed 5–1–07; 8:45 am] Act, as amended.
importance of testing glycerin for DEG. BILLING CODE 4160–01–S HRSA collects data in the UDS which
We are issuing this level 1 guidance is used to ensure compliance with
for immediate implementation, legislative mandates and to report to
consistent with FDA’s good guidance DEPARTMENT OF HEALTH AND Congress and policy makers on program
practices regulation (21 CFR 10.115). HUMAN SERVICES accomplishments. To meet these
The agency is not seeking comment objectives, HRSA requires a core set of
prior to implementing this guidance Health Resources and Services
Administration data collected annually that is
because of the potential for a serious appropriate for monitoring and
public health impact if DEG- evaluating performance and reporting
Agency Information Collection
contaminated glycerin were to enter the on annual trends.
Activities: Submission for OMB
domestic market. The guidance
Review; Comment Request Estimates of annualized reporting
represents the agency’s current thinking
on this issue. It does not create or confer Periodically, the Health Resources burden are as follows:
any rights for or on any person and does and Services Administration (HRSA)

Responses
Number of Total Hours per Total burden
Type of report per
respondents responses response hours
respondent

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 Dated: April 25, 2007. DEPARTMENT OF HEALTH AND
recommendations concerning the Caroline Lewis, HUMAN SERVICES
proposed information collection should Acting Associate Administrator for
be sent within 30 days of this notice to: Administration and Financial Management. National Institutes of Health
Karen Matsuoka, Human Resources and [FR Doc. E7–8379 Filed 5–1–07; 8:45 am]
Housing Branch, Office of Management Government-Owned Inventions;
BILLING CODE 4165–15–P
and Budget, New Executive Office Availability for Licensing
ycherry on PROD1PC64 with NOTICES

Building, Room 10235, Washington, DC

AGENCY: National Institutes of Health,
20503.
Public Health Service, HHS.
ACTION: Notice.

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