Federal Register / Vol. 72, No. 89 / Wednesday, May 9, 2007 / Notices 26399 

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. 

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 http://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 

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 

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 (http://www.fda.gov/cvm) 

and from the Division of Dockets 

Management Web site (http:// 

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 


sroberts on PROD1PC70 with NOTICES
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, closeended, 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

Type of respondents 

Estimated 

number of 

respondents 

Estimated 

number of responses per 

respondent 

Average burden per 

response 

Estimated total 

annual burden 

hours 

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 

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 

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 


sroberts on PROD1PC70 with NOTICES