3738 Federal Register / Vol. 75, No. 14 / Friday, January 22, 2010 / Notices 

System (OMB #0920–0612, exp. 1/31/ 

2010)—Revision—National Center for 

Chronic Disease Prevention and Health 

Promotion (NCCDPHP), Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

Cardiovascular disease (CVD), which 

includes heart disease, myocardial 

infarction, and stroke, is the leading 

cause of death for women in the United 

States, and is largely preventable. The 

WISEWOMAN program (Well-Integrated 

Screening and Evaluation for Women 

Across the Nation), administered by the 

Centers for Disease Control and 

Prevention (CDC), was established to 

examine ways of improving the delivery 

of services for women who have limited 

access to health care and elevated risk 

factors for CVD. The program focuses on 

reducing CVD risk factors and provides 

screening services for select risk factors 

such as elevated blood cholesterol, 

hypertension and abnormal blood 

glucose levels. The program also 

provides lifestyle interventions and 

medical referrals. The WISEWOMAN 

program serves women who are 

participating in the National Breast and 

Cervical Cancer Early Detection Program 

(NBCCEDP), also administered by CDC. 

CDC requests OMB approval to 

continue collecting information from 

WISEWOMAN grantees for three years, 

with changes. There will be a net 

decrease in the total annualized burden 

hours. Although the number of funded 

grantees will increase from 15 to 21, the 

burden per respondent will decrease 

due to changes in the data collection 

plan and schedule. The collection of 

cost information will be discontinued 

and the Progress Report will be 

collected semi-annually instead of 

quarterly. 

Twice per year, each grantee will 

electronically transmit a Minimum Data 

Elements (MDE) dataset that contains 

information about the women served 

through the WISEWOMAN program, 

including their demographics, health 

status, CVD risk factors, referrals and 

participation in lifestyle interventions. 

In addition, each grantee will submit 

two written progress reports per year. 

The progress reports provide a narrative 

summary of grantee activities, as well as 

a discussion of each grantee’s progress 

toward meeting stated programmatic 

objectives. The information collected 

from grantees is used to assess the 

impact of the WISEWOMAN program. 

The overall program evaluation is 

designed to demonstrate how 

WISEWOMAN can obtain more 

complete health data on vulnerable 

populations, promote public education 

about disease incidence and risk-factors, 

improve the availability of screening 

and diagnostic services for under-served 

women, ensure the quality of services 

provided to under-served women, and 

develop strategies for improved 

interventions. 

There are no costs to respondents 

other than their time. The total 

estimated annualized burden hours are 

1,680. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

WISEWOMAN Grantees ................................. Screening and Assessment MDEs ................ 21 2 16 

Intervention MDEs .......................................... 21 2 8 

Progress Report ............................................. 21 2 16 

Dated: January 15, 2010. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. 2010–1167 Filed 1–21–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0246] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Establishing and 

Maintaining a List of U.S. Dairy 

Product Manufacturers/Processors 

With Interest in Exporting to Chile 

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 February 

22, 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 e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0509. 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 (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 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. 

Establishing and Maintaining a List of 

U.S. Dairy Product Manufacturers/ 

Processors With Interest in Exporting to 

Chile (OMB Control Number 0910– 

0509)—Extension 

As a direct result of discussions that 

have been adjunct to the U.S./Chile Free 

Trade Agreement, Chile has recognized 

FDA as the competent U.S. food safety 

authority and has accepted the U.S. 

regulatory system for dairy inspections. 

Chile has concluded that it will not 

require individual inspections of U.S. 

firms by Chile as a prerequisite for 

trade, but will accept firms identified by 

FDA as eligible to export to Chile. 

Therefore, in the Federal Register of 

June 22, 2005 (70 FR 36190), FDA 

announced the availability of a revised 

guidance document entitled 

‘‘Establishing and Maintaining a List of 

U.S. Dairy Product Manufacturers/ 

Processors With Interest in Exporting to 

Chile.’’ The guidance can be found at 

http://www.cfsan.fda.gov/ 

guidance.html. The guidance document 

explains that FDA has established a list 

that is provided to the government of 

Chile and posted on http:// 


erowe on DSK5CLS3C1PROD with NOTICES
Federal Register / Vol. 75, No. 14 / Friday, January 22, 2010 / Notices 3739 

www.cfsan.fda.gov/~comm/ 

expcllst.html, which identifies U.S. 

dairy product manufacturers/processors 

that have expressed interest to FDA in 

exporting dairy products to Chile, are 

subject to FDA jurisdiction, and are not 

the subject of a pending judicial 

enforcement action (i.e., an injunction 

or seizure) or a pending warning letter. 

The term ‘‘dairy products,’’ for purposes 

of this list, is not intended to cover the 

raw agricultural commodity raw milk. 

Application for inclusion on the list is 

voluntary. However, Chile has advised 

that dairy products from firms not on 

this list could be delayed or prevented 

by Chilean authorities from entering 

commerce in Chile. The guidance 

explains what information firms should 

submit to FDA in order to be considered 

for inclusion on the list and what 

criteria FDA intends to use to determine 

eligibility for placement on the list. The 

document also explains how FDA 

intends to update the list and how FDA 

intends to communicate any new 

information to Chile. Finally, the 

guidance notes that FDA considers the 

information on this list, which is 

provided voluntarily with the 

understanding that it will be posted on 

FDA’s Web site and communicated to, 

and possibly further disseminated by, 

Chile, to be information that is not 

protected from disclosure under 5 

U.S.C. 552(b)(4). Under the guidance, 

FDA recommends that U.S. firms that 

want to be placed on the list send the 

following information to FDA: (1) Name 

and address of the firm and the 

manufacturing plant; (2) name, 

telephone number, and e-mail address 

(if available) of the contact person; (3) 

a list of products presently shipped and 

expected to be shipped in the next 3 

years; (4) identities of agencies that 

inspect the plant and the date of last 

inspection; (5) plant number and copy 

of last inspection notice; and (6) if other 

than an FDA inspection, copy of last 

inspection report. FDA requests that this 

information be updated every 2 years. 

In the Federal Register of June 4, 2009 

(74 FR 26867), FDA published a 60-day 

notice requesting public comment on 

the proposed collection of information. 

FDA received two letters in response, 

each containing one or more comments. 

The comments were outside the scope 

of the comment request in the notice. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Activity No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

New written requests to be 

placed on the list 15 1 15 1 .5 23 

Biannual update 88 1 88 1 .0 88 

Occasional updates 25 1 25 0 .5 13 

Total 124 

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

The estimate of the number of firms 

that will submit new written requests to 

be placed on the list, biannual updates 

and occasional updates is based on the 

FDA’s experience maintaining the list 

over the past 4 years. The estimate of 

the number of hours that it will take a 

firm to gather the information needed to 

be placed on the list or update its 

information is based on FDA’s 

experience with firms submitting 

similar requests. FDA believes that the 

information to be submitted will be 

readily available to the firms. 

To date, over 175 producers have 

sought to be included on the list. FDA 

estimates that, each year, approximately 

15 new firms will apply to be added to 

the list. We estimate that a firm will 

require 1.5 hours to read the guidance, 

gather the information needed, and to 

prepare a communication to FDA that 

contains the information and requests 

that the firm be placed on the list for a 

total of 22.5 hours, rounded to 23. 

Under the guidance, every 2 years each 

producer on the list must provide 

updated information in order to remain 

on the list. FDA estimates that each year 

approximately half of the firms on the 

list, 88 firms (175 x 0.5 = 87.5, rounded 

to 88), will resubmit the information to 

remain on the list. We estimate that a 

firm already on the list will require 1.0 

hours to biannually update and 

resubmit the information to FDA, 

including time reviewing the 

information and corresponding with 

FDA, for a total of 88 hours. In addition, 

FDA expects that, each year, 

approximately 25 firms will need to 

submit an occasional update and each 

firm will require 0.5 hours to prepare a 

communication to FDA reporting the 

change, for a total of 12.5 hours, 

rounded to 13. 

Dated: January 15, 2010. 

David Dorsey 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2010–1153 Filed 1–21–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Health Resources 

and Services Administration (HRSA) 

publishes abstracts of information 

collection requests under review by the 

Office of Management and Budget 

(OMB), in compliance with the 

Paperwork Reduction Act of 1995 (44 

U.S.C. Chapter 35). To request a copy of 

the clearance requests submitted to 

OMB for review, e-mail 

paperwork@hrsa.gov or call the HRSA 

Reports Clearance Office on (301) 443– 

1129. 

The following request has been 

submitted to the Office of Management 

and Budget for review under the 

Paperwork Reduction Act of 1995: 


erowe on DSK5CLS3C1PROD with NOTICES