59722 Federal Register / Vol. 75, No. 187 / Tuesday, September 28, 2010 / Notices 

one comment that was not responsive to 

the comment request on the information 

collection provision. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per 

Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

516.20 15 5 75 16 1,200 

516.26 3 1 3 2 6 

516.27 1 1 1 1 1 

516.29 2 1 2 1 2 

516.30 15 5 75 2 150 

516.36 1 1 1 3 3 

Total 1,362 

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

The burden estimate for this reporting 

requirement was derived in our Office 

of Minor Use and Minor Species Animal 

Drug Development by extrapolating the 

current investigational new animal drug 

(INAD)/new animal drug application 

(NADA) reporting requirements for 

similar actions by this same segment of 

the regulated industry and from 

previous interactions with the minor 

use/minor species community. 

Dated: September 23, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–24273 Filed 9–27–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0373] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Preparing a Claim 

of Categorical Exclusion or an 

Environmental Assessment for 

Submission to the Center for Food 

Safety and Applied Nutrition 

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 October 28, 

2010. 

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: 

202–395–7285, or emailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0541. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

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 

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

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Preparing a Claim of Categorical 

Exclusion or an Environmental 

Assessment for Submission to the 

Center for Food Safety and Applied 

Nutrition (OMB Control Number 0910– 

0541)—Extension 

As an integral part of its 

decisionmaking process, FDA is 

obligated under the National 

Environmental Policy Act of 1969 

(NEPA) to consider the environmental 

impact of its actions, including allowing 

notifications for food contact substances 

to become effective and approving food 

additive petitions, color additive 

petitions and GRAS petition requests for 

exemption from regulation as a food 

additive, and actions on certain food 

labeling citizen petitions, nutrient 

content claims petitions, and health 

claims petitions. In 1997, FDA amended 

its regulations in part 25 (21 CFR part 

25) to provide for categorical exclusions 

for additional classes of actions that do 

not individually or cumulatively have a 

significant effect on the human 

environment (62 FR 40570, July 29, 

1997). As a result of that rulemaking, 

FDA no longer routinely requires 

submission of information about the 

manufacturing and production of FDAregulated articles. FDA also has 

eliminated the previously required 

Environmental Assessment (EA) and 

abbreviated EA formats from the 

amended regulations. Instead, FDA has 

provided guidance that contains sample 

formats to help industry submit a claim 

of categorical exclusion or an EA to 

FDA’s Center for Food Safety and 

Applied Nutrition (CFSAN). The 

guidance document entitled ‘‘Preparing 

a Claim of Categorical Exclusion or an 

Environmental Assessment for 

Submission to the Center for Food 

Safety and Applied Nutrition’’ 

identifies, interprets, and clarifies 

existing requirements imposed by 

statute and regulation, consistent with 

the Council on Environmental Quality 

regulations (40 CFR 1507.3). It consists 

of recommendations that do not 

themselves create requirements; rather, 

they are explanatory guidance for FDA’s 

own procedures in order to ensure full 

compliance with the purposes and 

provisions of NEPA. 

The guidance provides information to 

assist in the preparation of claims of 

categorical exclusion and EAs for 

submission to CFSAN. The following 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 187 / Tuesday, September 28, 2010 / Notices 59723 

questions are covered in this guidance: 

(1) What types of industry-initiated 

actions are subject to a claim of 

categorical exclusion? (2) what must a 

claim of categorical exclusion include 

by regulation? (3) what is an EA? (4) 

when is an EA required by regulation 

and what format should be used? (5) 

what are extraordinary circumstances? 

and (6) what suggestions does CFSAN 

have for preparing an EA? Although 

CFSAN encourages industry to use the 

EA formats described in the guidance 

because standardized documentation 

submitted by industry increases the 

efficiency of the review process, 

alternative approaches may be used if 

these approaches satisfy the 

requirements of the applicable statutes 

and regulations. FDA is requesting the 

extension of OMB approval for the 

information collection provisions in the 

guidance. The likely respondents 

include businesses engaged in the 

manufacture or sale of food, food 

ingredients, and substances used in 

materials that come into contact with 

food. 

In the Federal Register of July 21, 

2010 (75 FR 42446), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. In response, the agency 

received one comment that was not 

responsive to the comment request on 

the information collection provisions. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

25.32(i) 34 1 34 1 34 

25.32(o) 1 1 1 1 1 

25.32(q) 2 1 2 1 2 

Total 37 

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

The estimates for respondents and 

numbers of responses are based on the 

annualized numbers of petitions and 

notifications qualifying for § 25.32(i) 

and (q) that the agency has received in 

the past 3 years. Please note that, in the 

past 3 years, there have been no 

submissions that requested an action 

that would have been subject to the 

categorical exclusion in § 25.32(o). To 

avoid counting this burden as zero, FDA 

has estimated the burden for this 

categorical exclusion at one respondent 

making one submission a year for a total 

of one annual submission. 

To calculate the estimate for the hours 

per response values, we assumed that 

the information requested in this 

guidance for each of these three 

categorical exclusions is readily 

available to the submitter. For the 

information requested for the exclusion 

in § 25.32(i), we expect that the 

submitter will need to gather 

information from appropriate persons in 

the submitter’s company and to prepare 

this information for attachment to the 

claim for categorical exclusion. We 

believe that this effort should take no 

longer than 1 hour per submission. For 

the information requested for the 

exclusions in § 25.32(o) and (q), the 

submitters will almost always merely 

need to copy existing documentation 

and attach it to the claim for categorical 

exclusion. We believe that collecting 

this information should also take no 

longer than 1 hour per submission. 

Dated: September 23, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–24272 Filed 9–27–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; Testing Successful Health 

Communications Surrounding AgingRelated Issues From the National 

Institute on Aging (NIA) 

SUMMARY: In compliance with the 

requirement of Section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

National Institute on Aging, the 

National Institutes of Health (NIH) 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: Testing 

successful health communications 

surrounding aging-related issues from 

the National Institute on Aging (NIA). 

Type of Information Collection Request: 

New. Need and Use of Information 

Collection: This study will support 

NIA’s mission ‘‘to communicate 

information about aging and advances 

in research on aging to the scientific 

community, health care providers, and 

the public.’’ The primary objectives of 

this study are to: 

• Assess audiences’ trusted/preferred 

sources for information, knowledge, 

attitudes, behaviors, and other 

characteristics for the planning/ 

development of health messages and 

communications strategies; 

• Pre-test health messages and 

outreach strategies while they are in 

developmental form to assess audience 

response, including their likes and 

dislikes. 

NIA’s Office of Communications and 

Public liaison will collect this 

information through formative 

qualitative research with its key 

audiences—older people, caregivers, 

and health professionals. Methods will 

include focus groups, individual 

interviews, self-administered 

questionnaires, and website surveys. 

The information will be used to (1) 

Develop and revise health information 

resources and outreach strategies to 

maximize their effectiveness; (2) 

determine new topic areas to explore for 

future NIA publications; and (3) identify 

new ways to support the health 

information needs of older adults and 

people who serve older adults. NIA is 

requesting a generic clearance for a 

range of research data collection 

procedures to ensure that they 

successfully develop and disseminate 

effective health communications on 

aging-related issues. Frequency of 

Response: On occasion. Affected Public: 

Older people, caregivers, and health 

professionals (physicians and nonphysicians). Type of Respondents: Older 


srobinson on DSKHWCL6B1PROD with NOTICES