Federal Register / Vol. 74, No. 114 / Tuesday, June 16, 2009 / Notices 28501 

15 minutes per week (71 FR 59653 at 

59667; October 11, 2006). 

The annual recordkeeping burden for 

mandatory reports and their associated 

notifications is thus estimated to be 300 

hours (1,200 × 0.25 hours). 

We do not expect that records will 

always be kept in relation to voluntary 

reporting, nor is any such recordkeeping 

required by section 417 of the act. 

Therefore, FDA estimates that records 

will be kept for 600 of the 1,200 

voluntary reports we expect to receive 

annually. The recordkeeping burden 

associated with voluntary reports is thus 

estimated to be 150 hours annually (600 

× 0.25 hours). 

The estimated total annual 

recordkeeping burden is shown in table 

2 of this document. 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

Activity No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records2

Hours per 

Record Total Hours 

Maintenance of reportable food 

records under section 417(g) of 

the act— 

Mandatory reports 1,200 1 1,200 0.25 300 

Maintenance of reportable food 

records under section 417(g) of 

the act— 

Voluntary reports 600 1 600 0.25 150 

Total 450 

1There are no capital or operating and maintenance costs associated with this collection of information. 

2For purposes of estimating number of records and hours per record, a ‘‘record’’ means all records kept for an individual reportable food by 

the responsible party or a voluntary reporter. 

The draft guidance also refers to 

previously approved collections of 

information found in FDA regulations. 

The collections of information in 

question 28 of the guidance have been 

approved under OMB control no. 0910– 

0249. 

Dated: June 9, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–14048 Filed 6–15–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; NIH Intramural Research 

Training Program Applications 

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 

Office of the Director, 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: NIH Intramural Research 

Training Program Applications. 

Type of Information Collection 

Request: Revision/OMB No. 0925–0299; 

8/31/2009. 

Need and Use of Information 

Collection: The proposed information 

collection activity is for the purpose of 

collecting applicant data for Training 

Fellowships in the NIH Intramural 

Research Program. This information 

must be submitted in order to receive 

due consideration for a fellowship and 

will be used to determine the eligibility 

and quality of potential awardees. 

Frequency of Response: On occasion. 

Affected Public: Individuals seeking 

intramural training opportunities and 

references for these individuals. 

Type of Respondents: Postdoctoral, 

predoctoral, postbaccalaureate, 

technical, clinical, and student IRTA 

applicants. 

There are no capital costs, operating 

costs, and/or maintenance costs to 

report. 

Type of respondent 

Estimated 

number of 

respondents 

Estimated 

number of 

responses per 

respondent 

Average burden 

hours per 

response 

Estimated total 

annual burden 

hours 

requested 

Postdoctoral ................................................................................................. 3,424 2 .00 1 .00 6,848 

Predoctoral ................................................................................................... 1,458 1 .00 1 .00 1,458 

Postbaccalaureate ....................................................................................... 4,750 1 .00 1 .00 4,750 

Technical ...................................................................................................... 233 1 .00 1 .00 233 

Clinical ......................................................................................................... 400 1 .00 1 .00 400 

Student ......................................................................................................... 14,334 1 .00 1 .00 14,334 

All categories (Race/Gender/Ethnicity survey) ............................................ 4,307 1 .00 0 .25 1,077 

References for all categories ....................................................................... 38,725 1 .00 1 .00 38,725 

Total ...................................................................................................... 67,631 1 .125 0 .90625 67,825 

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28502 Federal Register / Vol. 74, No. 114 / Tuesday, June 16, 2009 / Notices 

Request for Comments 

Written comments and/or suggestions 

from the public and affected agencies 

are invited on one or more of the 

following points: (1) Whether the 

proposed collection of information is 

necessary for the proper performance of 

the agency, including whether the 

information will have practical utility; 

(2) The accuracy of the agency’s 

estimate of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(3) Ways to enhance the quality, utility, 

and the clarity of information to be 

collected; and (4) Ways to 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 CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact: Steven Alves, 

Website Programs Specialist, Office of 

Intramural Training and Education, OD, 

NIH, Building 2, Room 2E06, 2 Center 

Drive MSC 0240, Bethesda, MD 20892– 

0240, or call non-toll-free number 301– 

402–1294, or e-mail your request, 

including your address to: 

alvess@mail.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: June 9, 2009. 

Sharon Milgram, 

Director, Office of Intramural Training & 

Education, National Institutes of Health. 

[FR Doc. E9–14156 Filed 6–15–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Agency for Healthcare Research 

and Quality, HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

intention of the Agency for Healthcare 

Research and Quality (AHRQ) to request 

that the Office of Management and 

Budget (OMB) approve the proposed 

information collection project: ‘‘CAHPS 

Field Test of Proposed Health 

Information Technology Questions and 

Methodology.’’ In accordance with the 

Paperwork Reduction Act of 1995, 

Public Law 104–13 (44 U.S.C. 

3506(c)(2)(A)), AHRQ invites the public 

to comment on this proposed 

information collection. 

This proposed information collection 

was previously published in the Federal 

Register on March 31, 2009 and allowed 

60 days for public comment. One 

comment was received. The purpose of 

this notice is to allow an additional 30 

days for public comment. This notice 

differs from the 60-day notice in the 

following ways: (1) The number of 

respondents has been increased from 

4,800 to 7,200; (2) the burden hours are 

increased from 1,600 to 2,400; (3) an 

incentive experiment has been added; 

and (4) an experiment testing the use of 

a 4-point vs. 6-point response scale has 

been added. 

DATES: Comments on this notice must be 

received by July 16, 2009. 

ADDRESSES: Written comments should 

be submitted to: AHRQ’s OMB Desk 

Officer by fax at (202) 395–6974 

(attention: AHRQ’s Desk Officer) or by 

e-mail at 

OIRA_submission@omb.eop.gov 

(attention: AHRQ’s Desk Officer). Copies 

of the proposed collection plans, data 

collection instruments, and specific 

details on the estimated burden can be 

obtained from the AHRQ Reports 

Clearance Officer. 

FOR FURTHER INFORMATION CONTACT: 

Doris Lefkowitz, AHRQ Reports 

Clearance Officer, (301) 427–1477, or by 

e-mail at doris.lefkowitz@ahrq.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Proposed Project 

‘‘CAHPS Field Test of Proposed Health 

Information Technology Questions and 

Methodology’’ 

The Consumer Assessment of 

Healthcare Providers and Systems 

(CAHPS®) program is a multi-year 

initiative of the Agency for Healthcare 

Research and Quality. AHRQ first 

launched the program in October 1995 

in response to concerns about the lack 

of good information about the quality of 

health plans from the enrollees’ 

perspective. Numerous public and 

private organizations collected 

information on enrollee and patient 

satisfaction, but the surveys varied from 

sponsor to sponsor and often changed 

from year to year. The CAHPS® 

program was designed to: 

• Make it possible to compare survey 

results across sponsors and over time; 

and 

• Generate tools and resources that 

sponsors can use to produce 

understandable and usable comparative 

information for consumers. 

Over time, the program has expanded 

beyond its original focus on health 

plans to address a range of health care 

services and meet the various needs of 

health care consumers, purchasers, 

health plans, providers, and 

policymakers. Based on the literature 

review and an assessment of currently 

available survey instruments, AHRQ 

identified the need to develop a new 

health information technology module 

of the CAHPS® survey. The intent of the 

planned module is to examine in greater 

detail than previously patients’ 

perspective on health information 

technology use by their health care 

professionals. The intent of the new 

module is to provide information to 

clinicians, group practices, health plans, 

and other interested parties regarding 

the impact of the use of health 

information technology on patients’ 

experiences with care. The set of 

questions about health information 

technology will be tested as a part of 

CAHPS® Clinician & Group Survey, 

Adult Primary Care Questionnaire. 

This study, funded through 

cooperative agreements with RAND and 

Harvard, is being conducted pursuant to 

AHRQ’s statutory authority to conduct 

research and evaluations on health care 

and systems for the delivery of such 

care, including activities with respect to 

(1) the quality, effectiveness, efficiency, 

appropriateness and value of health care 

services and (2) health care 

technologies, facilities and equipment. 

See 42 U.S.C. 299a(a)(1) and (5). 

This study is a one-time field test to 

be conducted in calendar year 2009. 

The field test to be conducted under this 

request will be done for the following 

purposes: 

a. Analysis of revised item wording— 

Assess candidate wordings for survey 

items. 

b. Mode Analysis—Evaluate the 

equivalence of items administered by 

mail, telephone, and Internet; compare 

the characteristics and responses of 

respondents who complete the survey 

by different modes of administration. 

c. Case mix adjustment analysis— 

Evaluate variables that need to be 

considered for case mix adjustment of 

scores. 

d. Psychometric Analysis—Provide 

information for the revision and 

shortening of questionnaires based on 

the assessment of the reliability and 

validity of survey items and composites. 

e. Test a 4-point vs. a 6-point response 

scale—The CAHPS Clinician & Group 

Survey will test both a 4-point response 

scale (Never, Sometimes, Usually, 

Always) and a 6-point response scale 

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