59074 Federal Register / Vol. 70, No. 195 / Tuesday, October 11, 2005 / Notices 

ways people can enter data into the 

electronic submission system to protect 

the database from corruption. 

FDA estimates the burden of the 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section Form No. No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

720.1 through 720.4 (new 

submissions) 

FDA 2512 and 

FDA 2512a 

112 12.9 1,446 0 .5 723 

720.4 and 720.6 (amendments) FDA 2512 and 

FDA 2512a 

112 0.5 52 0 .33 17 

720.3 and 720.6 (notices 

of discontinuance) 

FDA 2514 112 1 4 0 .1 0 .4 

720.8 (requests for confidentiality) 1 1 1 1 .5 1 .5 

Total 742 

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

These estimates are based on FDA’s 

experience with the Cosmetic Product 

Voluntary Reporting Program. The 

estimated annual total hours burden is 

75 percent of the burden reported in 

2002 due to decreased submissions. 

However, the number of respondents 

doubled, and FDA attributes this to 

increased interest in the program. FDA 

expects the number of submissions to 

increase accordingly in the next 3 years. 

Dated: October 3, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–20307 Filed 10–7–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0124] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Guidance for Industry: Notification of a 

Health Claim or Nutrient Content Claim 

Based on an Authoritative Statement 

of a Scientific Body 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Guidance for Industry: Notification of 

a Health Claim or Nutrient Content 

Claim Based on an Authoritative 

Statement of a Scientific Body’’ 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 June 16, 2005 (70 FR 

35097), 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 0910–0374. The 

approval expires on September 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 3, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–20308 Filed 10–7–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005D–0401] 

Draft Guidance for Industry and FDA 

Staff: Compliance With the Medical 

Device User Fee and Modernization 

Act of 2002, as amended—Prominent 

and Conspicuous Mark of 

Manufacturers on Single-Use Devices; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘Compliance With Section 301 

of the Medical Device User Fee and 

Modernization Act of 2002, as 

amended—Prominent and Conspicuous 

Mark of Manufacturers on Single-Use 

Devices.’’ The Medical Device User Fee 

and Modernization Act of 2002 

(MDUFMA), as amended by the Medical 

Device User Fee Stabilization Act of 

2005 (MDUFSA), requires that FDA 

issue guidance within 180 days of 

enactment (August 1, 2005) identifying 

the circumstances in which the name, 

abbreviation, or symbol identifying the 

manufacturer of an original device is not 

‘‘prominent and conspicuous.’’

DATES: Submit written or electronic 

comments on this draft guidance so that 

they are received by close of business on 

November 10, 2005. FDA will not be 

able to consider comments received 

after that date in developing the final 

guidance. FDA may consider late 

comments at a future time if the