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
59724 Federal Register / Vol. 75, No. 187 / Tuesday, September 28, 2010 / Notices 

people, caregivers, and health 

professionals (physicians and nonphysicians). The annual reporting 

burden is as follows: Estimated Number 

of Respondents: 630. Estimated Number 

of Responses per Respondent: 1. 

Average Burden Hours Per Response: 

0.37. Estimated Total Annual Burden 

Hours Requested: 234. The annualized 

cost to respondents is estimated at: 

$5,680. There are no Capital Costs to 

report. There are no Operating or 

Maintenance Costs to report. 

Type of respondents 

Estimated 

number of 

respondents 

Estimated 

number of 

responses per 

respondent 

Average burden 

hours per 

response 

Estimated total 

annual burden 

hours 

requested 

Older adults ................................................................................................... 260 1 .37 97 

Non-physician health professionals and caregivers ...................................... 310 1 .35 107 

Physicians ...................................................................................................... 60 1 .5 30 

Total ........................................................................................................ ........................ ........................ .......................... 234 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies should 

address one or more of the following 

points: (1) Evaluate whether the 

proposed collection of information is 

necessary for the proper performance of 

the function of the agency, including 

whether the information will have 

practical utility; (2) Evaluate the 

accuracy of the agency’s estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) Minimize the burden 

of the collection of information on those 

who are to respond, including the use 

of appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact: Megan Homer, 

Writer/Editor, Office of 

Communications and Public Liaison, 

NIH, Building 31C Room 5C27, 9000 

Rockville Pike, Bethesda, MD 20892, or 

call non-toll-free number 301–496–1752 

or E-mail your request, including your 

address to: homerm@mail.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of the date of 

this publication. 

Dated: September 22, 2010. 

Lynn Hellinger, 

Director of Management, National Institutes 

of Health. 

[FR Doc. 2010–24277 Filed 9–27–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; Transfusion-Transmitted 

Retrovirus and Hepatitis Virus Rates 

and Risk Factors: Improving the Safety 

of the U.S. Blood Supply Through 

Hemovigilance 

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 Heart, Lung, and Blood 

Institute (NHLBI), the National 

Institutes of Health (NIH), will publish 

periodic summaries of proposed 

projects to the Office of Management 

and Budget (OMB) for review and 

approval. 

Proposed Collection: Title: 

Transfusion-transmitted retrovirus and 

hepatitis virus rates and risk factors: 

Improving the safety of the U.S. blood 

supply through hemovigilance. Type of 

Information Collection Request: NEW. 

Need and Use of Information Collection: 

Information on current risk factors in 

blood donors as assessed using 

analytical study designs is largely 

unavailable in the U.S. Studies of risk 

factor profiles among HIV-infected 

donors were funded by the CDC for 

approximately 10 years after 

implementation of serologic screening 

in the mid-1980s, whereas studies of 

HTLV- and HCV-seropositive (and 

indeterminate) donors, funded by NIH, 

were conducted in the early 1990s, but 

unfortunately, none of these studies is 

ongoing. Infection trend analyses have 

been conducted by the American Red 

Cross (ARC). The findings show 

continued HIV risk with the prevalence 

of HIV in first time donors hovering 

around 10 per 100,000 donations in 

each of the last 10 years and the 

incidence in repeat donors increasing 

from 1.49 per 100,000 person-years in 

1999–2000 to 2.16 per 100,000 personsyears in 2007–2008. While the 

prevalence of HCV in first time donors 

decreased over this time interval from 

345 to 163 per 100,000 donations, the 

incidence in repeat donors did not 

decrease and evidence of incident 

infection in first time donors increased. 

Moreover specific age, gender and race/ 

ethnicity groups were over-represented. 

Significantly increased incidence of 

both HIV and HCV were observed in 

2007/2008 compared to 2005/2006. 

Similar analyses for HBV have shown 

an incidence in all donors of 3.4 per 

100,000 person-years which is lower 

than earlier estimates, but remains 

higher than for HIV and HCV. 

This project represents a collaborative 

pilot research study that will include a 

comprehensive interview study of viral 

infection positive blood donors at the 

American Red Cross (ARC), Blood 

Systems Inc. (BSI) and New York Blood 

Center (NYBC) in order to identify the 

current predominant risk factors for 

virus positive donations and will also 

establish a donor biovigilance capacity 

that currently does not exist in the U.S. 

At this time it is not easy to integrate 

risk factor data and disease marker 

surveillance information within or 

across different blood collection 

organizations because common 

interview procedures and laboratory 

confirmation procedures are not being 

used and so we cannot easily tabulate 

and analyze behavioral risks or viral 

infections in U.S. blood donors. This 

creates the potential for gaps in our 

understanding of absolute incidence 

and prevalence as well as risks that 

could lead to transfusion-transmitted 

disease. Combined data are critical for 

appropriate national surveillance 

efforts. For example, this information 

could be used to target educational 

interventions to reduce donations from 

persons with high risk behaviors. This 

is particularly important in the case of 


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