Federal Register / Vol. 73, No. 14 / Tuesday, January 22, 2008 / Notices 3731 

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 above. 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. 

Please note that on January 15, 2008, 

the FDA Web site transitioned to the 

Federal Dockets Management System 

(FDMS). FDMS is a Government-wide, 

electronic docket management system. 

Electronic submissions will be accepted 

by FDA through the FDMS only. 

Dated: January 14, 2008. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E8–1004 Filed 1–18–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0241] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Institutional Review Boards 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Institutional Review Boards’’ has been 

approved by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Karen L. Nelson, Office of the Chief 

Information Officer (HFA–250), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

4816. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of October 11, 2007 (72 

FR 57948), 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 0910–0130. The 

approval expires on December 31, 2010. 

A copy of the supporting statement for 

this information collection is available 

on the Internet at http:// 

www.reginfo.gov/public/do/PRAMain. 

Dated: January 14, 2008. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E8–1005 Filed 1–18–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2004N–0408] 

Regulatory Site Visit Training Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration’s (FDA’s) Center for 

Biologics Evaluation and Research 

(CBER) is reannouncing the invitation 

for participation in its Regulatory Site 

Visit Training Program (RSVP). This 

training program is intended to give 

CBER regulatory review, compliance, 

and other relevant staff an opportunity 

to visit biologics facilities. These visits 

are intended to allow CBER staff to 

directly observe routine manufacturing 

practices and to give CBER staff a better 

understanding of the biologics industry, 

including its challenges and operations. 

The purpose of this notice is to invite 

biologics facilities to contact CBER for 

more information if they are interested 

in participating in this program. 

DATES: Submit a written or electronic 

request for participation in this program 

by February 21, 2008. The request 

should include a description of your 

facility relative to products regulated by 

CBER. Please specify the physical 

address of the site(s) you are offering. 

Facilities should also be advised that if 

a site visit involves a separate physical 

location of another firm under contract 

to the applicant that this site must be in 

agreement to participate in the program, 

as well as have a satisfactory 

compliance history. 

ADDRESSES: If your biologics facility is 

interested in offering a site visit or 

learning more about this training 

opportunity for CBER staff, or if your 


sroberts on PROD1PC70 with NOTICES