Proposed Data Collections Submitted for Public Comment and Recommendations, 21809-21810 [E9-10937]
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21809
Federal Register / Vol. 74, No. 89 / Monday, May 11, 2009 / Notices
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
No. of
Respondents
21 CFR Section
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
1 There
4,500
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
Annual Frequency
per
Recordkeeping
No. of
Recordkeepers
21 CFR Section
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
1 There
450
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.
VerDate Nov<24>2008
15:05 May 08, 2009
Jkt 217001
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
PO 00000
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Fmt 4703
Sfmt 4703
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—
E:\FR\FM\11MYN1.SGM
11MYN1
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
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.
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 (https://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
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
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.
15:05 May 08, 2009
Jkt 217001
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
VerDate Nov<24>2008
Proposed Project
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
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
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
E:\FR\FM\11MYN1.SGM
11MYN1
]]>Agencies
[Federal Register Volume 74, Number 89 (Monday, May 11, 2009)]
[Notices]
[Pages 21809-21810]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-10937]
-----------------------------------------------------------------------
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--
[[Page 21810]]
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 (https://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
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Respondents Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
----------------------------------------------------------------------------------------------------------------
State and territory EHDI Program 53 1 4 212
Coordinators...............................
----------------------------------------------------------------------------------------------------------------
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
