Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Notices 61455 

whether advisory committee review is 

sought, and the expected outcome; (2) a 

statement identifying the review 

division/office that issued the original 

decision on the matter and, if 

applicable, the last agency official that 

attempted to formally resolve the 

matter; (3) a list of documents in the 

administrative file, or additional copies 

of such documents, that are deemed 

necessary for resolution of the issue(s); 

and (4) a statement that the previous 

supervisory level has already had the 

opportunity to review all of the material 

relied on for dispute resolution. The 

agency suggests submitting the 

following information with a formal 

request for dispute resolution: (1) 

Statements describing the issue from the 

perspective of the person with a 

dispute, (2) brief statements describing 

the history of the matter, and (3) the 

documents previously submitted to FDA 

under an OMB approved collection of 

information. 

Based on FDA’s experience with 

dispute resolution, the agency expects 

that most persons seeking formal 

dispute resolution will have gathered 

the materials listed previously when 

identifying the existence of a dispute 

with the agency. Consequently, FDA 

anticipates that the collection of 

information attributed solely to the 

guidance will be minimal. 

Respondents are expected to be 

sponsors, applicants, or manufacturers 

of drug or biological products regulated 

by the agency under section 505 of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 355) or section 351 of the 

Public Health Service Act (42 U.S.C. 

262) who request formal resolution of a 

scientific or procedural dispute. 

Provided below is an estimate of the 

annual reporting burden for requests for 

dispute resolution. Based on data 

collected from review divisions and 

offices within CDER and CBER, FDA 

estimates that approximately eight 

sponsors and applicants (respondents) 

submit requests for formal dispute 

resolution to CDER annually and 

approximately one respondent submits 

requests for formal dispute resolution to 

CBER annually. The total annual 

responses are the total number of 

requests submitted to CDER and CBER 

in 1 year, including requests for dispute 

resolution that a single respondent 

submits more than one time. FDA 

estimates that CDER receives 

approximately 10 requests annually and 

CBER receives approximately 1 request 

annually. The hours per response are 

the estimated number of hours that a 

respondent would spend preparing the 

information to be submitted with a 

request for formal dispute resolution in 

accordance with this guidance, 

including the time it takes to gather and 

copy brief statements describing the 

issue from the perspective of the person 

with the dispute, brief statements 

describing the history of the matter, and 

supporting information that has already 

been submitted to the agency. Based on 

experience, FDA estimates that 

approximately 8 hours on average 

would be needed per response. 

Therefore, FDA estimates that 88 hours 

will be spent per year by respondents 

requesting formal dispute resolution 

under the guidance. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Requests for Formal Dispute 

Resolution 

No. of 

Respondents 

Number of Responses 

per Respondent 

Total Annual 

Responses 

Hours per 

Response Total Hours 

CDER 8 1 .25 10 8 80 

CBER 1 1 1 8 8 

Total 88 

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

Dated: October 17, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–21156 Filed 10–21–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2004N–0516] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

2005 Food Safety Survey 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘2005 Food Safety Survey’’ has been 

approved by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Peggy Robbins, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1223. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of May 24, 2005 (70 FR 

29768), 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 0910–0345. The 

approval expires on February 30, 2008. 

A copy of the supporting statement 

for this information collection is 

available on the Internet at http:// 

www.fda.gov/ohrms/dockets. 

Dated: October 17, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–21157 Filed 10–21–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0216] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Medical Devices: 

Humanitarian Use Devices 

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