30 day FRN

33310

Federal Register / Vol. 75, No. 112 / Friday, June 11, 2010 / Notices
ANNUAL BURDEN ESTIMATES—Continued
Instrument

Number of respondents

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) ...............................................

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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
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,

HHS.
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Responses
per
respondent

Number of
respondents

Type of application form

ACTION:

Notice.

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

SUMMARY:

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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 http://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

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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 (http://
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