National Institutes of Health/National Institute of Environmental Health Sciences Proposed Collection; Comment Request; Program Assessment and Evaluations for NIEHS-Asthma Research, 26399-26400 [07-2285]

Download as PDF Federal Register / Vol. 72, No. 89 / Wednesday, May 9, 2007 / Notices comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper 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. Dated: May 1, 2007. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E7–8872 Filed 5–8–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D–0254] Guidance for Industry: Analytical Methods Description for Type C Medicated Feeds; Availability AGENCY: Food and Drug Administration, HHS. sroberts on PROD1PC70 with NOTICES ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance for industry (#137) entitled ‘‘Analytical Methods Description for Type C Medicated Feeds.’’ This guidance provides our recommendations for describing methods for analyzing new animal drugs in Type C medicated feeds. DATES: Submit written or electronic comments on agency guidances at any time. ADDRESSES: Submit written requests for single copies of the guidance to the Communications Staff (HFV–12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your requests. Submit written comments on the guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Comments should be identified with the full title of the guidance and the docket number found in brackets in the heading of this document. Submit electronic comments to https://www.fda.gov/dockets/ ecomments. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Rebecca Owen, Center for Veterinary VerDate Aug<31>2005 18:12 May 08, 2007 Jkt 211001 Medicine (HFV–141), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–276–9842, email: rebecca.owen@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of June 28, 2006 (71 FR 36813), FDA published the notice of availability for a draft guidance entitled ‘‘Analytical Methods Description for Type C Medicated Feeds’’ giving interested persons until September 11, 2006, to comment on the draft guidance. With the exception of one general comment regarding medicated feed, FDA received no specific comments on the guidance. The final guidance has not been substantively changed from the draft version. Section 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b) establishes the requirements for new animal drug approval. FDA regulations in part 514 (21 CFR part 514) specify the information you must submit as part of your new animal drug application (NADA) and the proper format for the NADA submission. As part of your NADA submission, you must include a ‘‘detailed description of the collection of samples and the analytical procedures to which they are subjected’’ (§ 514.1(b)(5)(vii)). This should include a description of practicable methods of analysis which have adequate sensitivity to determine the amount of the new animal drug in the final dosage form (§ 514.1(b)(5)(vii)(a)). This guidance provides recommendations for describing methods for analyzing new animal drugs in Type C medicated feeds. This guidance applies to instrumental methods only (e.g., high pressure liquid chromatography, gas chromatography). For information on other methods (e.g., microbiological methods) you should contact the Center for Veterinary Medicine (CVM). II. Significance of Guidance This level 1 guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). This guidance represents the agency’s current thinking on the 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 alternate method may be used as long as it satisfies the requirements of applicable statutes and regulations. 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 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 26399 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 § 514.1 have been approved under OMB control numbers 0910–0032 and 0910– 0154. IV. Comments Interested persons may, at any time, submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments should be identified with the docket number found in brackets in the heading of this document. A copy of the guidance and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. V. Electronic Access Copies of the guidance document entitled ‘‘Analytical Methods Description for Type C Medicated Feeds’’ may be obtained from the CVM home page (https://www.fda.gov/cvm) and from the Division of Dockets Management Web site (https:// www.fda.gov/ohrms/dockets/ default.htm). Dated: April 26, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–8808 Filed 5–8–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institutes of Health/National Institute of Environmental Health Sciences Proposed Collection; Comment Request; Program Assessment and Evaluations for NIEHS—Asthma Research Summary: In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Environmental Health Sciences, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Program Assessment and Evaluations for E:\FR\FM\09MYN1.SGM 09MYN1 26400 Federal Register / Vol. 72, No. 89 / Wednesday, May 9, 2007 / Notices NIEHS—Asthma Research. Type of Information Collection Request: New. New and Use of Information Collection: National Institute of Environmental Health Sciences, Division of Extramural Research and Training (DERT). DERT, with contract support from Battelle Centers for Public Health Research and Evaluation, is examining the impact of its research portfolio. Focusing specifically on one portion of the research portfolio—asthma research— DERT proposes to supplement extant data sources with a primary data collection activity. The purpose of the proposed primary data collection is to obtain information from grantees regarding the impact of their funded asthma research in the short-, intermediate- and long-term. This will be done through a survey of grantees that includes questions about the impact of funding on career development, the field of asthma research, public attitudes, commercial product development, clinical practice, business and industry practices, and long-term human and environmental health. Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: Individuals receiving asthma funding. A 15-minute, close- ended, multi-mode (web and paper) survey will be administered to the universe of NIEHS-funded asthma researchers (N=295) and comparison agency asthma researchers (N=4000). Comparison agencies include other NIH institutes (NICHD, NIAID, NIA, NHLBI), the CDC, AHRQ, and the EPA. The survey development process included formative interviews with a small couple of NIEHS asthma researchers. There are no Capital Costs, Operating Costs and/or Maintenance Costs to report. There are no costs to respondents except for their time to participate. ANNUALIZED BURDEN TABLE Estimated number of responses per respondent Estimated number of respondents Type of respondents Average burden per response Estimated total annual burden hours requested 4295 1 .25 1073.75 Total .......................................................................................................... sroberts on PROD1PC70 with NOTICES Asthma grantee ............................................................................................... ........................ ........................ ........................ 1073.75 Request for Comments: Written comments and/or suggestions from the public and affected agencies should address one or more of the following points: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. For Further Information: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Jerry Phelps, Division of Extramural Research and Training, National Institute of Environmental Health Sciences, P.O. Box 12233, MD ED–21, 111 T.W. Alexander Drive, RTP, NC 27709. Phone: (919) 541–4259. E-mail: phelps@niehs.nih.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60-days of the date of this publication. VerDate Aug<31>2005 18:12 May 08, 2007 Jkt 211001 Dated: April 22, 2007. Marc S. Hollander, NIEHS Associate Director for Management. [FR Doc. 07–2285 Filed 5–8–07; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health, Clinical Center Proposed Collection; Comment Request; Customer and Other Partners Satisfaction Surveys Summary: In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for the opportunity for pubic comment on the proposed data collection projects, the Warren Grant Magnuson Clinical Center (CC), the National Institutes of Health, (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Customer and Other Partners Satisfaction Surveys. Type of Information Collection Request: New request/waiver. Need and Use of Information Collection: The information collected in these surveys will be used by Clinical Center personnel: (1) To evaluate the satisfaction of various Clinical Center customers and other partners with Clinical Center services; (2) to assist with the design of modifications of these services, based PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 on customer input; (3) to develop new services, based on customer need; and (4) to evaluate the satisfaction of various Clinical Center customers and other partners with implemented service modifications. These surveys will almost certainly lead to quality improvement activities that will enhance and/or streamline the Clinical Center’s operations. The major mechanisms by which the Clinical Center will request customer input is through surveys and focus groups. The surveys will be tailored specifically to each class of customer and to that class of customer’s needs. Surveys will either be collected as written documents, as faxed documents, mailed electronically or collected by telephone from customers. Information gathered from these surveys of Clinical Center customers and other partners will be presented to, and used directly by, Clinical Center management to enhance the services and operations of our organization. Frequency of Response: The participants will respond yearly. Affected public: Individuals and households; businesses and other for profit, small businesses and organizations. Types of respondents: These surveys are designed to assess the satisfaction of the Clinical Center’s major internal and external customers with the services provided. These customers include, but are not limited to, the following groups of individuals: Clinical Center patients, family members of Clinical Center patients, visitors to the Clinical Center, National E:\FR\FM\09MYN1.SGM 09MYN1

Agencies

[Federal Register Volume 72, Number 89 (Wednesday, May 9, 2007)]
[Notices]
[Pages 26399-26400]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-2285]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

National Institutes of Health/National Institute of Environmental
Health Sciences Proposed Collection; Comment Request; Program
Assessment and Evaluations for NIEHS--Asthma Research

Summary: In compliance with the requirement of Section
3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity
for public comment on proposed data collection projects, the National
Institute of Environmental Health Sciences, the National Institutes of
Health (NIH) will publish periodic summaries of proposed projects to be
submitted to the Office of Management and Budget (OMB) for review and
approval.
Proposed Collection: Title: Program Assessment and Evaluations for

[[Page 26400]]

NIEHS--Asthma Research. Type of Information Collection Request: New.
New and Use of Information Collection: National Institute of
Environmental Health Sciences, Division of Extramural Research and
Training (DERT). DERT, with contract support from Battelle Centers for
Public Health Research and Evaluation, is examining the impact of its
research portfolio. Focusing specifically on one portion of the
research portfolio--asthma research--DERT proposes to supplement extant
data sources with a primary data collection activity. The purpose of
the proposed primary data collection is to obtain information from
grantees regarding the impact of their funded asthma research in the
short-, intermediate- and long-term. This will be done through a survey
of grantees that includes questions about the impact of funding on
career development, the field of asthma research, public attitudes,
commercial product development, clinical practice, business and
industry practices, and long-term human and environmental health.
Frequency of Response: Once. Affected Public: Individuals. Type of
Respondents: Individuals receiving asthma funding. A 15-minute, close-
ended, multi-mode (web and paper) survey will be administered to the
universe of NIEHS-funded asthma researchers (N=295) and comparison
agency asthma researchers (N=4000). Comparison agencies include other
NIH institutes (NICHD, NIAID, NIA, NHLBI), the CDC, AHRQ, and the EPA.
The survey development process included formative interviews with a
small couple of NIEHS asthma researchers. There are no Capital Costs,
Operating Costs and/or Maintenance Costs to report. There are no costs
to respondents except for their time to participate.

Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
Estimated Estimated
Estimated number of Average burden total annual
Type of respondents number of responses per per response burden hours
respondents respondent requested
----------------------------------------------------------------------------------------------------------------
Asthma grantee.................................. 4295 1 .25 1073.75
---------------------------------------------------------------
Total....................................... .............. .............. .............. 1073.75
----------------------------------------------------------------------------------------------------------------

Request for Comments: Written comments and/or suggestions from the
public and affected agencies should address one or more of the
following points: (1) Evaluate whether the proposed collection of
information is necessary for the proper performance of the function of
the agency, including whether the information will have practical
utility; (2) Evaluate the accuracy of the agency's estimate of the
burden of the proposed collection of information, including the
validity of the methodology and assumptions used; (3) Enhance the
quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who
are to respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.
For Further Information: To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, contact: Jerry Phelps, Division of Extramural Research and
Training, National Institute of Environmental Health Sciences, P.O. Box
12233, MD ED-21, 111 T.W. Alexander Drive, RTP, NC 27709. Phone: (919)
541-4259. E-mail: phelps@niehs.nih.gov.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 60-days
of the date of this publication.

Dated: April 22, 2007.
Marc S. Hollander, NIEHS
Associate Director for Management.
[FR Doc. 07-2285 Filed 5-8-07; 8:45 am]
BILLING CODE 4140-01-M

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