Agency Information Collection Activities: Submission for OMB Review; Comment Request, 33310-33311 [2010-14108]
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33310
Federal Register / Vol. 75, No. 112 / Friday, June 11, 2010 / Notices
ANNUAL BURDEN ESTIMATES—Continued
Number of respondents
Instrument
Number of responses per
respondent
Average burden hours per
response
100
1
0.75
75
100
20
1
1
0.75
8
75
160
20
1
33.50
670
20
1
33.50
670
20
60
1
1
33.50
0.75
670
45
DD Council: Group Interview with Recipients of Self-Advocacy and Leadership Education and Training ........................................................................
DD Council: Group Interview with Recipients of Education and Training to
Improve Community Capacity ......................................................................
DD Council: Self-administered Form ...............................................................
DD Council Estimate of Total Burden Hours for Activities to Support Administration of Proposed Information Collection Instruments ............................
P&A Estimate of Total Burden Hours for Activities to Support Administration
of Proposed Information Collection Instruments ..........................................
UCEDD Estimate of Total Burden Hours for Activities to Support Administration of Proposed Information Collection Instruments ...............................
ADD Assessment Survey ................................................................................
Estimated Total Annual Burden
Hours: 4,120.
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: June 7, 2010.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2010–14002 Filed 6–10–10; 8:45 am]
BILLING CODE 4184–01–P
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
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
General Information Worksheet .........................................
Planning Grant: General Information Worksheet ..............
BPHC Funding Request Summary ....................................
Documents on File .............................................................
Proposed Staff Profile ........................................................
Income Analysis Form .......................................................
Community Characteristics ................................................
Health Care Plan (Competing) ..........................................
Health Care Plan (Non-Competing) ...................................
Business Plan (Competing) ...............................................
VerDate Mar<15>2010
15:04 Jun 10, 2010
Jkt 220001
Responses
per
respondent
Number of
respondents
Type of application form
PO 00000
Frm 00073
1,034
250
1,034
1,034
1,034
1,034
1,034
800
1,034
800
Fmt 4703
Sfmt 4703
Total burden
hours
and Budget for review under the
Paperwork Reduction Act of 1995:
Proposed Project: Federally Qualified
Health Centers (FQHC) Application
Forms: (OMB No. 0915–0285)—
Revisions
HRSA’s Bureau of Primary Health
Care administers grants to Health
Centers receiving funding under section
330 of the Public Health Service Act and
has an approval process for
organizations seeking to qualify as
Federally Qualified Health Center
(FQHC) Look Alikes. These Health
Centers and FQHC Look Alikes provide
preventive and primary health care
services to low-income and other
vulnerable populations, regardless of
their ability to pay and whether or not
they have health insurance. Many
Health Centers and FQHC Look-Alikes
offer dental, mental health and
substance abuse care.
HRSA uses the following application
forms to administer Section 330 Health
Centers grants and the FQHC Look Alike
application process. These application
forms are used by new and existing
Health Centers and FQHC Look-Alikes
to apply for grant and non-grant
opportunities, renew their grant or nongrant opportunities or change their
scope of project.
Estimates of annualized reporting
burden are as follows:
Total
responses
1
1
1
1
1
1
1
1
1
1
E:\FR\FM\11JNN1.SGM
1,034
250
1,034
1,034
1,034
1,034
1,034
1,034
1,034
1,034
11JNN1
Hours per
response
Total burden
hours
2.0
2.5
2.0
1.0
2.0
5.0
1.0
4.0
2.0
4.0
2,068
625
2,068
1,034
2,068
5,170
1,034
4,136
2,068
4,136
33311
Federal Register / Vol. 75, No. 112 / Friday, June 11, 2010 / Notices
Responses
per
respondent
Number of
respondents
Type of application form
Total
responses
Hours per
response
Total burden
hours
Business Plan (Non-Competing) .......................................
Services Provided ..............................................................
Sites Listing ........................................................................
Other Site Activities ...........................................................
Change In Scope (CIS) Site Add Checklist .......................
CIS Site Delete Checklist ..................................................
CIS Relocation Checklist ...................................................
CIS Service Add Checklist .................................................
CIS Service Delete Checklist .............................................
Board Member Characteristics ..........................................
Request for Waiver of Governance Requirements ...........
Health Center Affiliation Certification .................................
Need for Assistance ...........................................................
Emergency Preparedness Form ........................................
Points of Contact ...............................................................
EHR Readiness Checklist ..................................................
Environmental Information and Documentation (EID) .......
Capital Improvement/Investment Proposal Cover Page ...
Assurances ........................................................................
Capital Improvement/Investment Project Cover ................
Capital Improvement/Investment Project Impact ...............
Equipment List ...................................................................
Other Requirements for Sites ............................................
1,034
1,034
1,034
700
300
200
200
100
100
1,034
150
250
900
1,034
800
250
400
700
900
700
700
900
900
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1,034
1,034
1,034
700
300
200
200
200
100
1,034
150
250
900
1,034
800
250
400
700
900
700
700
900
900
2.0
1.0
1.0
0.5
1.0
1.0
1.5
1.0
1.0
1.0
1.0
1.0
3.0
1.0
0.5
1.0
2.0
1.0
.5
1.0
.5
1.0
.5
2,068
1,034
1,034
350
300
200
300
200
100
1,034
150
250
2,700
1,034
400
250
800
700
450
700
350
900
450
Total ............................................................................
1,138
1
23,976
..........................
40,161
Written comments and
recommendations concerning the
proposed information collection should
be sent within 30 days of this notice to
the desk officer for HRSA, either by
email to
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974. Please direct all
correspondence to the ‘‘attention of the
desk officer for HRSA.’’
Dated: June 7, 2010.
Sahira Rafiullah,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2010–14108 Filed 6–10–10; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0433] (formerly
Docket No. 2007D–0169)
Guidance for Industry on
Bioequivalence Recommendations for
Specific Products; Availability
AGENCY:
Food and Drug Administration,
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Bioequivalence
Recommendations for Specific
Products.’’ This guidance describes a
new process for making available
VerDate Mar<15>2010
15:04 Jun 10, 2010
Jkt 220001
recommendations on how to design
product-specific bioequivalence (BE)
studies to support abbreviated new drug
applications (ANDAs). Under this
process, applicants planning to carry
out such studies in support of their
ANDAs are able to access BE study
guidance on the FDA Web site. FDA
believes that making this information
available on the Internet will streamline
the guidance process and will provide a
meaningful opportunity for the public to
consider and comment on productspecific BE study recommendations.
DATES: Submit either electronic or
written comments on agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Doan T. Nguyen, Center for Drug
Evaluation and Research (HFD–600),
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240–
276–9314.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Bioequivalence Recommendations for
Specific Products.’’ This guidance
describes a new process for making
available recommendations on how to
design product-specific BE studies to
support ANDAs. Under this process,
draft and final BE recommendations are
posted on FDA’s Web site (https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, Individual
Product Bioequivalence
Recommendations) and announced
periodically in the Federal Register. For
draft BE recommendations, the Federal
Register notice will identify a comment
period. The public is encouraged to
submit comments on the draft BE
recommendations, and the agency will
consider received comments in
developing final BE recommendations.
FDA adopted this process as a means to
develop and disseminate productspecific BE recommendations and
provide an opportunity for the public to
consider and comment on those
recommendations.
In the Federal Register of May 31,
2007 (72 FR 30388), FDA announced the
availability of a draft version of this
guidance entitled ‘‘Bioequivalence
Recommendations for Specific
E:\FR\FM\11JNN1.SGM
11JNN1
]]>Agencies
[Federal Register Volume 75, Number 112 (Friday, June 11, 2010)]
[Notices]
[Pages 33310-33311]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-14108]
-----------------------------------------------------------------------
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:
Proposed Project: Federally Qualified Health Centers (FQHC) Application
Forms: (OMB No. 0915-0285)--Revisions
HRSA's Bureau of Primary Health Care administers grants to Health
Centers receiving funding under section 330 of the Public Health
Service Act and has an approval process for organizations seeking to
qualify as Federally Qualified Health Center (FQHC) Look Alikes. These
Health Centers and FQHC Look Alikes provide preventive and primary
health care services to low-income and other vulnerable populations,
regardless of their ability to pay and whether or not they have health
insurance. Many Health Centers and FQHC Look-Alikes offer dental,
mental health and substance abuse care.
HRSA uses the following application forms to administer Section 330
Health Centers grants and the FQHC Look Alike application process.
These application forms are used by new and existing Health Centers and
FQHC Look-Alikes to apply for grant and non-grant opportunities, renew
their grant or non-grant opportunities or change their scope of
project.
Estimates of annualized reporting burden are as follows:
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Type of application form respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
General Information Worksheet.. 1,034 1 1,034 2.0 2,068
Planning Grant: General 250 1 250 2.5 625
Information Worksheet.........
BPHC Funding Request Summary... 1,034 1 1,034 2.0 2,068
Documents on File.............. 1,034 1 1,034 1.0 1,034
Proposed Staff Profile......... 1,034 1 1,034 2.0 2,068
Income Analysis Form........... 1,034 1 1,034 5.0 5,170
Community Characteristics...... 1,034 1 1,034 1.0 1,034
Health Care Plan (Competing)... 800 1 1,034 4.0 4,136
Health Care Plan (Non- 1,034 1 1,034 2.0 2,068
Competing)....................
Business Plan (Competing)...... 800 1 1,034 4.0 4,136
[[Page 33311]]
Business Plan (Non-Competing).. 1,034 1 1,034 2.0 2,068
Services Provided.............. 1,034 1 1,034 1.0 1,034
Sites Listing.................. 1,034 1 1,034 1.0 1,034
Other Site Activities.......... 700 1 700 0.5 350
Change In Scope (CIS) Site Add 300 1 300 1.0 300
Checklist.....................
CIS Site Delete Checklist...... 200 1 200 1.0 200
CIS Relocation Checklist....... 200 1 200 1.5 300
CIS Service Add Checklist...... 100 1 200 1.0 200
CIS Service Delete Checklist... 100 1 100 1.0 100
Board Member Characteristics... 1,034 1 1,034 1.0 1,034
Request for Waiver of 150 1 150 1.0 150
Governance Requirements.......
Health Center Affiliation 250 1 250 1.0 250
Certification.................
Need for Assistance............ 900 1 900 3.0 2,700
Emergency Preparedness Form.... 1,034 1 1,034 1.0 1,034
Points of Contact.............. 800 1 800 0.5 400
EHR Readiness Checklist........ 250 1 250 1.0 250
Environmental Information and 400 1 400 2.0 800
Documentation (EID)...........
Capital Improvement/Investment 700 1 700 1.0 700
Proposal Cover Page...........
Assurances..................... 900 1 900 .5 450
Capital Improvement/Investment 700 1 700 1.0 700
Project Cover.................
Capital Improvement/Investment 700 1 700 .5 350
Project Impact................
Equipment List................. 900 1 900 1.0 900
Other Requirements for Sites... 900 1 900 .5 450
--------------------------------------------------------------------------------
Total...................... 1,138 1 23,976 ............... 40,161
----------------------------------------------------------------------------------------------------------------
Written comments and recommendations concerning the proposed
information collection should be sent within 30 days of this notice to
the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by fax to 202-395-6974. Please direct all
correspondence to the ``attention of the desk officer for HRSA.''
Dated: June 7, 2010.
Sahira Rafiullah,
Director, Division of Policy and Information Coordination.
[FR Doc. 2010-14108 Filed 6-10-10; 8:45 am]
BILLING CODE 4165-15-P
