Federal Register / Vol. 73, No. 148 / Thursday, July 31, 2008 / Notices 44749 

Dated: July 25, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–17566 Filed 7–30–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0094] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Channels of Trade Policy for 

Commodities With Residues of 

Pesticide Chemicals, for Which 

Tolerances Have Been Revoked, 

Suspended, or Modified by the 

Environmental Protection Agency 

Pursuant to Dietary Risk 

Considerations 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Channels of Trade Policy for 

Commodities With Residues of Pesticide 

Chemicals, for Which Tolerances Have 

Been Revoked, Suspended, or Modified 

by the Environmental Protection Agency 

Pursuant to Dietary Risk 

Considerations’’ has been approved by 

the Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3794. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of May 16, 2008 (73 FR 

28484), the agency announced that the 

proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

agency may not conduct or sponsor, and 

a person is not required to respond to, 

a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0562. The 

approval expires on July 31, 2011. A 

copy of the supporting statement for this 

information collection is available on 

the Internet at http://www.reginfo.gov/ 

public/do/PRAMain. 

Dated: July 25, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–17576 Filed 7–30–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0047] (formerly 

Docket No. 2008N–0005) 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Formal Dispute 

Resolution: Scientific and Technical 

Issues Related to Pharmaceutical 

Current Good Manufacturing Practice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by September 

2, 2008. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974, or e-mailed to 

baguilar@omb.eop.gov. All comments 

should be identified with the OMB 

control number 0910–0563. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management (HFA–710), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–796–3792. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Formal Dispute Resolution: Scientific 

and Technical Issues Related to 

Pharmaceutical Current Good 

Manufacturing Practice—(OMB Control 

Number 0910–0563)—Extension 

The guidance is intended to provide 

information to manufacturers of 

veterinary and human drugs, including 

human biological drug products, on 

how to resolve disputes of scientific and 

technical issues relating to Current 

Good Manufacturing Practice (CGMP). 

Disputes related to scientific and 

technical issues may arise during FDA 

inspections of pharmaceutical 

manufacturers to determine compliance 

with CGMP requirements, or during 

FDA’s assessment of corrective actions 

undertaken as a result of such 

inspections. The guidance provides 

procedures that encourage open and 

prompt discussion of disputes and lead 

to their resolution. The guidance 

describes procedures for raising such 

disputes to the Office of Regulatory 

Affairs (ORA) and center levels and for 

requesting review by the dispute 

resolution (DR) Panel (the DR Panel). 

When a scientific or technical issue 

arises during an FDA inspection, the 

manufacturer should initially attempt to 

reach agreement on the issue informally 

with the investigator. Certain scientific 

or technical issues may be too complex 

or time-consuming to resolve during the 

inspection. If resolution of a scientific or 

technical issue is not accomplished 

through informal mechanisms prior to 

the issuance of Form FDA 483, the 

manufacturer can formally request DR 

and can use the formal two-tiered DR 

process described in the guidance. 

Tier-one of the formal DR process 

involves scientific or technical issues 

raised by a manufacturer to the ORA 

and center levels. If a manufacturer 

disagrees with the tier-one decision, tier 

two of the formal DR process would 

then be available for appealing that 

decision to the DR Panel. 

The written request for formal DR to 

the appropriate ORA unit should be 

made within 30 days of the completion 

of an inspection, and should include all 

supporting documentation and 

arguments for review, as described 

below. The written request for formal 

DR to the DR Panel should be made 

within 60 days of receipt of the tier-one 

decision, and should include all 

supporting documentation and 

arguments, as described in the following 

paragraphs. 

All requests for formal DR should be 

in writing and include adequate 

information to explain the nature of the 

dispute and to allow FDA to act quickly 

and efficiently. Each request should be 

sent to the appropriate address listed in 

the guidance and include the following: 

• Cover sheet that clearly identifies 

the submission as either a request for 

tier-one DR or a request for tier-two DR; 

• Name and address of manufacturer 

inspected (from Form FDA 483); 


jlentini on PROD1PC65 with NOTICES
44750 Federal Register / Vol. 73, No. 148 / Thursday, July 31, 2008 / Notices 

• Date of inspection (from Form FDA 

483); 

• Date the Form FDA 483 issued (from 

Form FDA 483); 

• FEI Number, if available (from Form 

FDA 483); 

• FDA employee names and titles that 

conducted inspection (from Form FDA 

483); 

• Office responsible for the 

inspection, e.g., district office (from 

Form FDA 483); 

• Application number if the 

inspection was a preapproval 

inspection; 

• Comprehensive statement of each 

issue to be resolved; 

• Identify the observation in dispute; 

• Clearly present the manufacturer’s 

scientific position or rationale 

concerning the issue under dispute with 

any supporting data; 

• State the steps that have been taken 

to resolve the dispute, including any 

informal DR that may have occurred 

before the issuance of Form FDA 483; 

• Identify possible solutions; 

• State expected outcome; 

• Name, title, telephone and fax 

number, and e-mail address (as 

available) of manufacturer contact. 

The guidance was part of the FDA 

initiative ‘‘Pharmaceutical cGMPs for 

the 21st Century: A Risk-Based 

Approach,’’ which was announced in 

August 2002. The initiative focuses on 

FDA’s current CGMP program and 

covers the manufacture of veterinary 

and human drugs, including human 

biological drug products. The agency 

formed the Dispute Resolution Working 

Group comprising representatives from 

ORA, the Center for Drug Evaluation 

and Research (CDER), the Center for 

Biologics Evaluation and Research 

(CBER), and the Center for Veterinary 

Medicine (CVM). The working group 

met weekly on issues related to the DR 

process and met with stakeholders in 

December 2002 to seek their input. 

The guidance was initiated in 

response to industry’s request for a 

formal DR process to resolve differences 

related to scientific and technical issues 

that arise between investigators and 

pharmaceutical manufacturers during 

FDA inspections of foreign and 

domestic manufacturers. In addition to 

encouraging manufacturers to use 

currently available DR processes, the 

guidance describes the formal twotiered DR process explained previously 

in this document. The guidance also 

covers the following topics: 

• The suitability of certain issues for 

the formal DR process, including 

examples of some issues with a 

discussion of their appropriateness for 

the DR process. 

• Instructions on how to submit 

requests for formal DR and a list of the 

supporting information that should 

accompany these requests. 

• Public availability of decisions 

reached during the dispute resolution 

process to promote consistent 

application and interpretation of drug 

quality-related regulations. 

Description of Respondents: 

Pharmaceutical manufacturers of 

veterinary and human drug products 

and human biological drug products. 

Burden Estimate: Based on the 

number of requests for tier-one and tiertwo DR received by FDA since the 

guidance published in January 2006, 

FDA estimates that approximately two 

manufacturers will submit 

approximately two requests annually for 

a tier-one DR, and that there will be one 

appeal of these requests to the DR Panel 

(request for tier-two DR). FDA estimates 

that it will take manufacturers 

approximately 30 hours to prepare and 

submit each request for a tier-one DR, 

and approximately 8 hours to prepare 

and submit each request for a tier-two 

DR. Table 1 of this document provides 

an estimate of the annual reporting 

burden for requests for tier-one and tiertwo DRs. 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours Per 

Response Total Hours 

Requests for Tier-One DR 2 1 2 30 60 

Requests for Tier-Two DR 1 1 1 8 8 

Total 68 

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

In the Federal Register of January 22, 

2008 (73 FR 3729), FDA published a 60- 

day notice requesting public comment 

on the information collection 

provisions. We received one comment 

in response to the January 22, 2008, 

Federal Register notice. The comment 

asked 3 questions about the DR process 

set forth in the guidance. 

First, the comment asked how many 

working days are taken by the ORA and 

center levels to reach a decision after 

receipt of a request for tier-one DR. 

FDA Response—As explained in 

Section III.A of the guidance, if the ORA 

unit agrees with the manufacturer, the 

ORA unit will issue a written response 

to the manufacturer within 30 days of 

receipt of the request, noting its 

agreement with the manufacturer and 

resolution of the dispute. If the ORA 

unit disagrees with the manufacturer, 

the ORA unit will issue a written 

response to the manufacturer generally 

within 30 days of receipt of the request, 

and if the ORA unit is unable to 

complete its review of the request and 

respond within 30 days, the ORA unit 

will notify the manufacturer, explain 

the reason for the delay (which may 

include the need for an additional 30 

days for center review), and discuss the 

time frame for completing the review. 

Second, the comment asked how 

many working days are taken by the DR 

Panel to reach a decision after receipt of 

a request for tier-two DR. 

FDA Response—As explained in 

Section III.B of the guidance, if the DR 

Panel determines that the request is 

appropriate for review, it will schedule 

a meeting to discuss the issue within 90 

days. If the DR Panel agrees with the 

manufacturer on the issue, the executive 

secretary of the DR Panel will issue a 

written response to the manufacturer 

within 30 days of the meeting, noting its 

agreement with the manufacturer and 

resolution of the dispute. If the DR 

Panel disagrees with the manufacturer 

on the issue, the executive secretary of 

the DR Panel will issue a written 

response to the manufacturer within 30 

days of the meeting, noting its decision 

on the issue. If the DR Panel determines 

that the request does not qualify for 

review, the executive secretary of the 

DR Panel will notify the manufacturer 

in writing within 30 days of receipt of 

the appeal. If FDA is unable to complete 

its review of the request and respond 

within 30 days, the executive secretary 

of the DR Panel will notify the 


jlentini on PROD1PC65 with NOTICES
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 


jlentini on PROD1PC65 with NOTICES