Federal Register / Vol. 74, No. 89 / Monday, May 11, 2009 / Notices 21809 

348) establishes a premarket approval 

requirement for ‘‘food additives;’’ 

section 201(s) of the act (21 U.S.C. 321) 

provides an exemption from the 

definition off ‘‘food additive’’ and thus 

from the premarket approval 

requirement, for uses of substances that 

are Generally Recognized as Safe 

(GRAS) by qualified experts. In April 

1997, FDA proposed a voluntary 

procedure whereby manufacturers 

would notify FDA about a view that a 

particular use (or uses) of a substance is 

not subject to the statutory premarket 

approval requirements based on a 

determination that such use is GRAS (62 

FR 18938, April 17, 1997). Proposed 

§§ 170.36 and 570.36 provide a standard 

format for the voluntary submission of 

a notice. The notice would include a 

detailed summary of the data and 

information that support the GRAS 

determination, and the notifier would 

maintain a record of such data and 

information. FDA would make the 

information describing the subject of the 

GRAS notice, and the agency’s response 

to the notice, available in a publicly 

accessible file; the entire GRAS notice 

would be publicly available consistent 

with the Freedom of Information Act 

and other Federal disclosure statutes. 

Description of Respondents: 

Manufacturers of Substances Used in 

Food and Feed. 

In the Federal Register of February 

11, 2009 (74 FR 6894), FDA published 

a 60-day notice requesting public 

comment on the information collection 

provisions. No comments were received. 

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 

170.36 25 1 25 150 3,750 

570.36 5 1 5 150 750 

Total 4,500 

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

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per 

Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

170.36(c)(v) 25 1 25 15 375 

570.36(c)(v) 5 1 5 15 75 

Total 450 

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

In the proposed rule, FDA estimated 

that the Center for Food Safety and 

Applied Nutrition (CFSAN) would 

receive approximately 50 GRAS notices 

per year and that the Center for 

Veterinary Medicine (CVM) would 

receive approximately 10 GRAS notices 

per year. Although FDA requested 

comment on this estimate, the 

comments did not provide useful 

information regarding this issue. 

Therefore, FDA evaluated the number of 

notices received by CFSAN to date. 

CFSAN received 274 GRAS notices 

during the 11–year period from 1998 

through 2008, for an average of 

approximately 25 GRAS notices per 

year. Based on this experience, FDA is 

revising its estimate of the annual 

number of GRAS notices submitted to 

CFSAN to be 25 or less. FDA also is 

revising its estimate of the annual 

number of GRAS notices submitted to 

CVM to be 5 or less. 

Dated: May 4, 2009. 

Jeffrey Shuren 

Associate Commissioner for Policy. 

[FR Doc. E9–10964 Filed 5–8–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–09–0733] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

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 

Centers for Disease Control and 

Prevention (CDC) will publish periodic 

summaries of proposed projects. To 

request more information on the 

proposed projects or to obtain a copy of 

the data collection plans and 

instruments, call 404–639–5960 and 

send comments to Maryam I. Daneshvar, 

CDC Acting Reports Clearance Officer, 

1600 Clifton Road, MS–D74, Atlanta, 

GA 30333 or send an e-mail to 

omb@cdc.gov. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Written comments should 

be received within 60 days of this 

notice. 

Proposed Project 

CDC Early Hearing Detection and 

Intervention Hearing Screening and 

Follow-up Survey, OMB #0920–0733— 

21810 Federal Register / Vol. 74, No. 89 / Monday, May 11, 2009 / Notices 

Revision—National Center on Birth 

Defects and Developmental Disabilities 

(NCBDDD), Centers for Disease Control 

and Prevention (CDC). 

Background and Brief Description 

The National Center on Birth Defects 

and Developmental Disabilities at CDC 

promotes the health of babies, children, 

and adults with disabilities. As part of 

these efforts the Center is actively 

involved in addressing hearing loss (HL) 

among newborns and infants. HL is a 

common birth defect that affects 

approximately 12,000 infants each year 

and, when left undetected, can result in 

developmental delays. As awareness 

about infant HL increases, so does the 

demand for accurate information about 

rates of screening, referral, loss to 

follow-up, and incidence. This 

information is important for helping to 

ensure infants and children are 

receiving recommended screening and 

follow-up services, documenting the 

occurrence and etiology of differing 

degrees of HL among infants, and 

determining the overall impact of infant 

HL on future outcomes, such as 

cognitive development, and family 

dynamics. These data will also assist 

state Early Hearing Detection and 

Intervention (EHDI) programs with 

quality improvement activities and 

provide information that will be helpful 

in assessing the impact of federal 

initiatives. The public will be able to 

access this information via the CDC 

EHDI Web site (http://www.cdc.gov/ 

ncbddd/ehdi/data.htm). 

Given the lack of a standardized and 

readily accessible source of data, the 

CDC EHDI program developed a survey 

to be used annually that utilizes 

uniform definitions to collect aggregate, 

standardized EHDI data from states and 

territories. The request to complete this 

survey is planned to be disseminated to 

respondents via an e-mail, which will 

include a summary of the request and 

other relevant information. Minor 

changes to this survey, based on 

respondent feedback, are planned in 

order to make the survey easier to 

complete and further improve data 

quality. These changes include splitting 

the previously combined questions 

about the number of infants that died 

and parents refused into two separate 

questions, adding a question about how 

many infants with hearing loss are 

receiving only monitoring services, 

simplifying the table for reporting type 

and severity of hearing loss data, and 

expanding the maternal race categories 

in the demographic section. 

There are no costs to the respondents 

other than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Respondents Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

State and territory EHDI Program Coordinators .............................................. 53 1 4 212 

Dated: May 5, 2009. 

Marilyn S. Radke, 

Reports Clearance Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. E9–10937 Filed 5–8–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–09–08BL] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) publishes a list of 

information collection requests under 

review by the Office of Management and 

Budget (OMB) in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

requests, call the CDC Reports Clearance 

Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written 

comments to CDC Desk Officer, Office of 

Management and Budget, Washington, 

DC or by fax to (202) 395–6974. Written 

comments should be received within 30 

days of this notice. 

Proposed Project 

Multi-site HIV Testing in Community 

Mental Health Settings Serving African 

Americans—New—National Center for 

HIV, Viral Hepatitis, STD and TB 

Prevention (NCHHSTP), Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

People with severe mental illness, 

including those with substance use 

disorders, are at increased risk of 

infection with human 

immunodeficiency virus (HIV) when 

compared with the general population. 

However, not enough is known about 

the risk behaviors, willingness to be 

tested for HIV, and prevalence of HIV 

among persons with severe mental 

illness. In addition, the interrelations 

among diagnosis of HIV, compliance 

with medical care, subsequent risk 

behaviors, and the course of mental 

illness have not been well-described. 

Mental health clinics are an important 

setting for testing and promoting 

prevention efforts against the 

transmission of HIV. 

The objectives of this project are to (1) 

demonstrate improved access to HIV 

testing and linkage to care in 

participating mental health care settings 

and (2) describe the relationship 

between mental illness, HIV risk 

behaviors, and access to testing and 

services, in order to inform the 

development of optimal prevention 

interventions for persons with severe 

mental illness. Staff at selected 

implementation sites will offer testing 

for HIV to clients and administer a brief 

survey to assess risk behaviors, previous 

access to similar testing services, and 

mental health symptoms. This project 

will collect data from clients using brief 

surveys administered on a voluntary 

basis. Collection of data will provide 

information on client demographics; 

current behaviors that may facilitate 

HIV transmission, including sexual and 

drug-use behaviors; current psychiatric 

symptoms, determined using brief rating 

scales; access and barriers to HIV 

testing, prevention, and treatment 

services; and adherence to psychiatric 

and medical treatment regimens. CDC is 

requesting approval for a 2-year 

clearance for data collection. Data will 

be collected in 6 sites which provide 

mental health services. 

The goal will be to approach 716 

persons annually for participation in the 

study and interview a total of 600 

persons. Based on the University of 

Pennsylvania’s prior experience 

working in mental health settings, it is 

estimated that of the 716 approached for 

participation in the study, the response 

rate will be approximately 90%. Of the 

644 persons approached who agree to be