Federal Register / Vol. 73, No. 148 / Thursday, July 31, 2008 / Notices 44751 

manufacturer, explain the reasons for 

the delay, and discuss the time frame for 

completing the review. 

Third, the comment asked whether 

‘‘the manufacturing facility is 

approvable or to be re-inspected’’ if the 

dispute is not resolved at the end of the 

tier-two DR stage. 

FDA Response—As described in the 

guidance, it is FDA’s intention to 

resolve through the DR process all 

issues raised by the manufacturer. If 

FDA agrees with the manufacturer, the 

Form FDA 483 that prompted the 

request for formal dispute resolution 

would be revised or rescinded. If FDA 

disagrees with the manufacturer’s 

request, the issues raised in the Form 

FDA 483 stand and FDA would expect 

compliance with the applicable CGMP 

requirements, which FDA may verify by 

re-inspection. 

Dated: July 25, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–17577 Filed 7–30–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Data Collection; Comment 

Request; Public Health Service; The 

National Survey of Physician Attitudes 

Regarding the Care of Cancer 

Survivors (SPARCCS) (NCI) 

SUMMARY: In compliance with the 

provisions of Section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comments on 

proposed data collection projects, the 

National Institutes of Health (NIH), 

National Cancer Institute (NCI) 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: The 

National Survey of Physician Attitudes 

Regarding the Care of Cancer Survivors 

(SPARCCS); Type of Information 

Collection Request: NEW; Need and Use 

of Information Collection: The purpose 

of SPARCCS is to identify the beliefs, 

knowledge, attitudes, and practices of 

primary care physicians and cancer 

specialists regarding the components 

described by the Institute of Medicine’s 

(IOM) 2005 report that described the 

essential components of cancer 

survivorship care within a health care 

delivery system. These data will inform 

the process of standardization of 

survivorship care practices; augment the 

data collected in other cancer 

survivorship studies such as the Cancer 

Care Outcomes Research and 

Surveillance Consortium (CanCORS), 

and the Cancer Research Network; and 

monitor the progress made toward 

achieving NCI strategic goals of 

improving the quality of cancer care 

across the cancer control continuum. 

Two questionnaires, one sent to primary 

care physicians and one sent to medical 

oncologists, will be administered by 

mail to a randomly selected national 

sample of 2,200 physicians. Study 

participants will be 1,100 practicing 

physicians who are family practitioners, 

general internists, and obstetrician/ 

gynecologists and 1,100 medical 

oncologists. Frequency of Response: 

Once. Affected Public: Individuals and 

Businesses. Type of Respondents: 

Primary care and medical oncology 

physicians practicing in a non-federal 

facility. The annual reporting burden is 

estimated at 903 hours as shown in 

Table 1. The total burden hours is 

estimated at 1,808 hours over the two 

year field period of the study. There are 

no capital, operating or maintenance 

costs to report. 

TABLE 1—ESTIMATES OF ANNUAL BURDEN HOURS

Type of respondents Survey Number of 

respondents 

Frequency of 

response 

Average time 

per response 

(minutes/hour) 

Annual burden 

hours 

Receptionists ..................................... Screener ........................................... 2,033 1 5/60 169 

Family Practice ................................. PCP Instrument ................................ 250 1 20/60 83 

General Internists .............................. PCP Instrument ................................ 250 1 20/60 83 

OB/GYNs .......................................... PCP Instrument ................................ 50 1 20/60 17 

Oncologists ....................................... Oncology Instrument ........................ 550 1 20/60 183 

Receptionists & Administrators ......... Follow-Up Phone Calls .................... 1,103 4 5/60 368 

Total ........................................... ........................................................... 4,236 ........................ ........................ 903 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(a) Whether the proposed collection of 

information is necessary for the 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

FOR FURTHER INFORMATION CONTACT: 

Send comments to Arnold Potosky, 

PhD, Health Services and Economics, 

Branch Applied Research Program, 

Division of Cancer Control and 

Population Sciences, National Cancer 

Institute, 6130 Executive Blvd., EPN 

Room 4005, Bethesda, MD 20892–7344 

Telephone: (301) 496–5662; e-mail: 

potoskya@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: July 21, 2008. 

Vivian Horovitch-Kelley, 

NCI Project Clearance Liaison Office, 

National Institutes of Health. 

[FR Doc. E8–17505 Filed 7–30–08; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request 

Evaluation of Risk Factors Associated 

With Viral Infections in Chinese Donors: 

a. Risk factors associated with HIV 


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