Federal Register / Vol. 75, No. 234 / Tuesday, December 7, 2010 / Notices 76011 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Item Nunber of 

respondents 

Annual 

frequency per 

response 

Total annual 

responses 

Hours per 

response Total hours 

MedSun facilities participating in the electronic reporting of 

adverse events program .................................................. 400 15 6,000 0.75 4,500 

MedSun facilities’ electronic responses to Public Health 

Questions (PHQs) ............................................................ 400 10 4,000 0.5 2,000 

Total hours .................................................................... ........................ ........................ ........................ ........................ 6,500 

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

Dated: December 1, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–30583 Filed 12–6–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0083] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Substances Prohibited From Use in 

Animal Food or Feed; Animal Proteins 

Prohibited in Ruminant Feed 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Substances Prohibited From Use in 

Animal Food or Feed; Animal Proteins 

Prohibited in Ruminant Feed’’ has been 

approved by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3793. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of June 18, 2010 (75 FR 

34744), 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 0910–0339. The 

approval expires on November 30, 2013. 

A copy of the supporting statement for 

this information collection is available 

on the Internet at http:// 

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

Dated: December 1, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–30556 Filed 12–6–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2004–N–0056] (formerly 

2004N–0234) 

Annual Guidance Agenda 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing its 

annual guidance document agenda. This 

list is being published under FDA’s 

good guidance practices (GGPs) 

regulations. It is intended to seek public 

comment on possible topics for future 

guidance document development or 

revisions of existing ones. 

DATES: Submit either electronic or 

written comments on this list and on 

any agency guidance document at any 

time. 

ADDRESSES: Submit electronic 

comments to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: For 

general information regarding FDA’s 

GGP policy contact: Lisa Helmanis, 

Office of Policy, Food and Drug 

Administration, 10903 New Hampshire 

Ave., WO32, rm. 3216, Silver Spring, 

MD 20993–0002, 301–796–9135. 

For information regarding specific 

topics or guidances, please see contact 

persons or specific offices listed in the 

table in the SUPPLEMENTARY INFORMATION

section of this document. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of September 

19, 2000 (65 FR 56468), FDA issued its 

final rule on GGPs (21 CFR 10.115). 

GGPs are intended to ensure 

involvement of the public in the 

development of guidance documents 

and to enhance understanding of the 

availability, nature, and legal effect of 

such guidance documents. 

As part of FDA’s effort to ensure 

meaningful interaction with the public 

regarding guidance documents, the 

Agency committed to publishing an 

annual guidance document agenda of 

possible guidance topics or documents 

for development or revision during the 

coming year. The Agency also 

committed to soliciting public input 

regarding these and additional ideas for 

new topics or revisions to existing 

guidance documents (65 FR 56468 at 

56477; 21 CFR 10.115(f)(5)). 

The Agency is neither bound by this 

list of possible topics nor required to 

issue every guidance document on this 

list or precluded from issuing guidance 

documents not on the list set forth in 

this document. 

The following list of guidance topics 

or documents represents possible new 

topics or revisions to existing guidance 

documents that the Agency is 

considering. The Agency solicits 

comments on the topics listed in this 

document and also seeks additional 

ideas from the public. 

The guidance documents are 

organized by the issuing Center or 

Office within FDA, and in some cases 

are further grouped within the issuing 

Center or Office by topic categories. 

II. Center for Biologics Evaluation and 

Research (CBER) 


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