Submission for OMB Review; Comment Request, 815-816 [E9-100]
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Federal Register / Vol. 74, No. 5 / Thursday, January 8, 2009 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Extension to HS Transportation
Requirement.
granted when the Head Start or Early
Head Start grantee demonstrates that
compliance with the requirement(s) for
which the waiver is being sought will
result in a significant disruption to the
Head Start program or the Early Head
Start program and that waiving the
requirement(s) is in the best interest of
the children involved.
Respondents: Head Start and Early
Head Start program grants recipients.
OMB No.: 0970–0260.
Description: The Office of Head Start
is proposing to renew authority to
collect information regarding the Head
Start transportation requirement
without changes. The transportation
requirement provides the requirement
that each child be seated in a child
restraint system while the vehicle is in
motion, and the requirement that each
bus have at least one bus monitor on
board at all times. Waivers would be
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average burden
hours per
response
Total burden
hours
Form .................................................................................................
1,670
1
1
1,670
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Estimated Total Annual Burden
Hours: 1,670.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments 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)
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.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: January 5, 2009.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E9–98 Filed 1–7–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Cross-Site Evaluation of the
Infant Adoption Awareness Training
Program for Projects Initially Funded in
Fiscal Year 2006–NEW.
OMB No.: New Collection.
Description: The Administration for
Children and Families (ACF), Childrens
Bureau (CB), will conduct the Cross-Site
Evaluation of the Infant Adoption
Awareness Training Program (IAATP).
Title XII, Subtitle A, of the Childrens
Health Act of 2000 (CHA) authorizes the
Department of Health and Human
Services to make Infant Adoption
Awareness Training grants available to
national, regional, and local adoption
organizations for the purposes of
developing and implementing programs
that train the staff of public and nonprofit private health service
organizations to provide adoption
information and referrals to pregnant
women on an equal basis with all other
courses of action included in nondirective counseling of pregnant
women. Participants in the training
include individuals who provide
pregnancy or adoption information and
those who will provide such services
after receiving the training, with Title X
(relating to voluntary family planning
projects), Section 330 (relating to
community health centers, migrant
health centers, and centers serving
homeless individuals and residents of
public housing), and CHA-funded
school-based health centers, receiving
priority to receive the training. A total
PO 00000
Frm 00023
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Sfmt 4703
of six organizations were awarded
IAATP funding in 2006.
Section 1201(a)(2)(A) of the IAATP
legislation requires grantees to develop
and deliver trainings that are consistent
with the Best Practice Guidelines for
Infant Adoption Awareness Training.
The IAATP guidelines address training
goals, basic skills, curriculum and
training structure. A complete
description of the guidelines is available
at https://www.acf.hhs.gov/programs/cb/
programs_fund/discretionary/iaatp.htm.
In addition, grantees are required to
conduct local evaluation of program
outcomes and participate in the national
evaluation of the extent to which IAATP
training objectives are met. The Infant
Adoption Awareness Training Program:
Trainee Survey is the primary data
collection instrument for the national
cross-site evaluation. Respondents will
complete the survey prior to receiving
training and approximately 90 days after
the training to assess the extent to
which trainees demonstrate sustained
gains in their knowledge about
adoption, and to determine the impact
of the training on their subsequent work
with pregnant women.
1. Do health care workers who
participate in the IAATP training:
Demonstrate enhanced knowledge,
attitudes, skills, and behaviors with
respect to adoption counseling
following completion of the program?
Provide adoption information to
pregnant women on an equal basis with
other pregnancy planning options?
Demonstrate enhanced awareness of
community adoption-related resources
and refer expectant mothers to them as
needed?
2. Are trainees more confident about
discussing all three pregnancy planning
options (parenting, abortion, and
adoption) in a non-directive counseling
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08JAN1
816
Federal Register / Vol. 74, No. 5 / Thursday, January 8, 2009 / Notices
style than they were prior to
participating in the training? Cross-site
evaluation data will be collected on an
annual basis throughout the five-year
funding period. Pre-test and follow-up
versions of the survey are expected to
require approximately 10 to 15 minutes
to complete. Estimated response time
for the follow-up survey includes time
for respondents to access the Web-based
survey, complete the survey online, and
electronically submit the survey.
Respondents will not need to
implement a recordkeeping system or
compile source data in order to
complete the survey. Where possible,
fields in the follow-up version of the
survey will be pre-filled with static data
from the respondents pre-test (e.g.,
demographics, agency type) in order to
further expedite completion of the
survey and minimize respondent
burden.
Respondents: Infant Adoption
Awareness Program Trainees.
ANNUAL BURDEN ESTIMATES
IAATP: Trainee Survey Pre-Test Administration .............................
IAATP: Trainee Survey Follow-Up Administration ...........................
Estimated Total Annual Burden
Hours: 300.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Administration, Office of Information
Services, 370 L’Enfant Promenade, SW.,
Washington, DC 20447, Attn: ACF
Reports Clearance Officer. All requests
should be identified by the title of the
information collection. E-mail address:
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Fax: 202–395–6974,
Attn: Desk Officer for the
Administration for Children and
Families.
Dated: October 1, 2008.
Janean Chambers,
Reports Clearance Officer.
Editorial Note: This document was
received at the Office of the Federal Register
on January 5, 2009.
[FR Doc. E9–100 Filed 1–7–09; 8:45 am]
erowe on PROD1PC63 with NOTICES
BILLING CODE 4184–01–P
Number of
responses per
respondent
Number of
respondents
Instrument
1,200
1,200
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2005–N–0464] (formerly
Docket No. 2005N–0403)
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Draft Guidance for
Industry on Providing Regulatory
Submissions in Electronic Format—
Drug Establishment Registration and
Drug Listing
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 9,
2009.
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:
202–395–6974, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0045. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3794.
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Average burden
hours per
response
1
1
Total burden
hours
0.15
0.10
180
120
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Draft Guidance for Industry on
Providing Regulatory Submissions in
Electronic Format—Drug Establishment
Registration and Drug Listing;
Availability; Registration of Producers
of Drugs and Listing of Drugs in
Commercial Distribution—(OMB
Control Number 0910–0045—
Amendment)
Description of Respondents:
Respondents to this collection of
information are foreign and domestic
owners and operators of establishments
that engage in the manufacture,
preparation, propagation, compounding,
or processing (which includes, among
other things, repackaging and
relabeling) of a drug or drugs1 and that
are not exempt under section 510(g) of
the Federal Food, Drug, and Cosmetic
Act (the act) or subpart B of part 207 (21
CFR part 207) (registrants).
A. Reporting Burden
The draft guidance describes how to
electronically create and submit
Structured Product Labeling (SPL) files
using defined code sets and codes for
establishment registration and drug
listing information (including labeling).
Most information is already required to
be submitted under section 510 of the
act, section 351 of the Public Health
Service Act, and part 207.
Drug establishment registration and
drug listing information and updates to
such information, required under part
207, and certain additional
recommended information are currently
submitted in paper form using Form
FDA 2656 (Registration of Drug
1 Means both human, including biological
products, and animal drugs.
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]]>Agencies
[Federal Register Volume 74, Number 5 (Thursday, January 8, 2009)]
[Notices]
[Pages 815-816]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-100]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: Cross-Site Evaluation of the Infant Adoption Awareness
Training Program for Projects Initially Funded in Fiscal Year 2006-NEW.
OMB No.: New Collection.
Description: The Administration for Children and Families (ACF),
Childrens Bureau (CB), will conduct the Cross-Site Evaluation of the
Infant Adoption Awareness Training Program (IAATP). Title XII, Subtitle
A, of the Childrens Health Act of 2000 (CHA) authorizes the Department
of Health and Human Services to make Infant Adoption Awareness Training
grants available to national, regional, and local adoption
organizations for the purposes of developing and implementing programs
that train the staff of public and non-profit private health service
organizations to provide adoption information and referrals to pregnant
women on an equal basis with all other courses of action included in
non-directive counseling of pregnant women. Participants in the
training include individuals who provide pregnancy or adoption
information and those who will provide such services after receiving
the training, with Title X (relating to voluntary family planning
projects), Section 330 (relating to community health centers, migrant
health centers, and centers serving homeless individuals and residents
of public housing), and CHA-funded school-based health centers,
receiving priority to receive the training. A total of six
organizations were awarded IAATP funding in 2006.
Section 1201(a)(2)(A) of the IAATP legislation requires grantees to
develop and deliver trainings that are consistent with the Best
Practice Guidelines for Infant Adoption Awareness Training. The IAATP
guidelines address training goals, basic skills, curriculum and
training structure. A complete description of the guidelines is
available at https://www.acf.hhs.gov/programs/cb/programs_fund/
discretionary/iaatp.htm.
In addition, grantees are required to conduct local evaluation of
program outcomes and participate in the national evaluation of the
extent to which IAATP training objectives are met. The Infant Adoption
Awareness Training Program: Trainee Survey is the primary data
collection instrument for the national cross-site evaluation.
Respondents will complete the survey prior to receiving training and
approximately 90 days after the training to assess the extent to which
trainees demonstrate sustained gains in their knowledge about adoption,
and to determine the impact of the training on their subsequent work
with pregnant women.
1. Do health care workers who participate in the IAATP training:
Demonstrate enhanced knowledge, attitudes, skills, and behaviors with
respect to adoption counseling following completion of the program?
Provide adoption information to pregnant women on an equal basis with
other pregnancy planning options? Demonstrate enhanced awareness of
community adoption-related resources and refer expectant mothers to
them as needed?
2. Are trainees more confident about discussing all three pregnancy
planning options (parenting, abortion, and adoption) in a non-directive
counseling
[[Page 816]]
style than they were prior to participating in the training? Cross-site
evaluation data will be collected on an annual basis throughout the
five-year funding period. Pre-test and follow-up versions of the survey
are expected to require approximately 10 to 15 minutes to complete.
Estimated response time for the follow-up survey includes time for
respondents to access the Web-based survey, complete the survey online,
and electronically submit the survey. Respondents will not need to
implement a recordkeeping system or compile source data in order to
complete the survey. Where possible, fields in the follow-up version of
the survey will be pre-filled with static data from the respondents
pre-test (e.g., demographics, agency type) in order to further expedite
completion of the survey and minimize respondent burden.
Respondents: Infant Adoption Awareness Program Trainees.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
IAATP: Trainee Survey Pre-Test 1,200 1 0.15 180
Administration.........................
IAATP: Trainee Survey Follow-Up 1,200 1 0.10 120
Administration.........................
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 300.
Additional Information: Copies of the proposed collection may be
obtained by writing to the Administration for Children and Families,
Office of Administration, Office of Information Services, 370 L'Enfant
Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance
Officer. All requests should be identified by the title of the
information collection. E-mail address: infocollection@acf.hhs.gov.
OMB Comment: OMB is required to make a decision concerning the
collection of information between 30 and 60 days after publication of
this document in the Federal Register. Therefore, a comment is best
assured of having its full effect if OMB receives it within 30 days of
publication. Written comments and recommendations for the proposed
information collection should be sent directly to the following: Office
of Management and Budget, Paperwork Reduction Project, Fax: 202-395-
6974, Attn: Desk Officer for the Administration for Children and
Families.
Dated: October 1, 2008.
Janean Chambers,
Reports Clearance Officer.
Editorial Note: This document was received at the Office of the
Federal Register on January 5, 2009.
[FR Doc. E9-100 Filed 1-7-09; 8:45 am]
BILLING CODE 4184-01-P
