30 Day FRN

62792

Federal Register / Vol. 229, No. 74 / Tuesday, December 1, 2009 / Notices

to the Web sites after this document
publishes in the Federal Register.)
1. Malam, S., S. Clegg, S. Kirwan, and S.
McGinigal, ‘‘Comprehension and Use of UK
Nutrition Signpost Labelling Schemes,’’
report prepared for Food Standards Agency,
May 2009.
2. Borgmeier, I, and J. Westenhoefer,
‘‘Impact of Different Food Label Formats on
Healthiness Evaluation and Food Choice of
Consumers: a Randomized-Controlled
Study,’’ BMC Public Health, 9: 184, 2009,
accessed online at http://
www.biomedcentral.com/content/pdf/14712458-9-184.pdf.
3. Kelly, B, C. Hughes, K. Chapman, J.C.Y. Louie, H. Dixon, J. Crawford, L. King, M.
Daube, T. Slevin, ‘‘Consumer Testing of the
Acceptability and Effectiveness of Front-ofPack Food Labelling Systems for the
Australian Grocery Market,’’ Health
Promotion International 24(2):120–9, 2009.
4. Feunekes, G.I.J., I.A. Gortemaker, A.A.
Willems, R. Lion, and M. van den Kommer,
‘‘Front-of-pack Nutrition Labelling: Testing
Effectiveness of Different Nutrition Labelling
Formats Front-of-pack in Four European
Countries,’’ Appetite, 50:57–70, 2008.
Dated: November 24, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–28699 Filed 11–30–09; 8:45 am]

Proposed Project: National Health
Service Corps Travel Request
Worksheet (OMB No. 0915–0278)—
Extension

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
[email protected] 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:

BILLING CODE 4160–01–S

Number of respondents

Form
Travel Request Worksheet ..................................................

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
e-mail to
[email protected] or by
fax to 202–395–6974. Please direct all
correspondence to the ‘‘attention of the
desk officer for HRSA.’’
Dated: November 24, 2009.
Alexandra Huttinger,
Director, Division of Policy Review and
Coordination.
[FR Doc. E9–28698 Filed 11–30–09; 8:45 am]

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Responses
per respondent

140

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
[email protected] 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:

Frm 00059

Fmt 4703

Sfmt 4703

Total responses

2

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

PO 00000

Clinicians participating in the HRSA
National Health Service Corps (NHSC)
Scholarship Program use the online
Travel Request Worksheet to receive
travel funds from the Federal
Government to perform pre-employment
interviews at sites on the NHSC’s
Opportunities List.
The travel approval process is
initiated when a scholar notifies the
NHSC of an impending interview at one
or more NHSC approved practice sites.
The Travel Request Worksheet is also
used to initiate the relocation process
after a NHSC scholar has successfully
been matched to an approved practice
site. Upon receipt of the Travel Request
Worksheet, the NHSC will review and
approve or disapprove the request and
promptly notify the scholar and the
NHSC logistics contractor regarding
travel arrangements and authorization of
the funding for the site visit or
relocation.
The estimated annual burden is as
follows:

280

Hours per response
.06

Total burden
hours
16.8

Proposed Project: The Health Education
Assistance Loan (HEAL) Program:
Forms (OMB No. 0915–0043 Extension)
The Health Education Assistance
Loan (HEAL) program continues to
administer and monitor outstanding
loans which were provided to eligible
students to pay for educational costs in
a number of health professions. HEAL
forms collect information that is
required for responsible program
management. The HEAL Repayment
Schedule, Fixed and Variable, provides
the borrower with the cost of a HEAL
loan, the number and amount of
payments, and the Truth-in-Lending
disclosures. The Lender’s Report on
HEAL Student Loans Outstanding (Call
Report), provides information on the
status of loans outstanding by the
number of borrowers and total number
of loans whose loan payments are in
various stages of the loan cycle, such as
student education and repayment, and
the corresponding dollar amounts.
These forms are needed to provide
borrowers with information on the cost
of their loan(s) and to determine which

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Federal Register / Vol. 229, No. 74 / Tuesday, December 1, 2009 / Notices
lenders may have excessive
delinquencies and defaulted loans.

The annual estimate of burden is as
follows:
Number of
respondents

Instrument
Disclosure: Repayment Schedule HRSA 502–1,2 ..............
Reporting: Call Report HRSA 512 .......................................
Total Reporting and Disclosure ...........................................

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 [email protected]
or by fax to 202–395–6974. Please direct
all correspondence to the ‘‘attention of
the desk officer for HRSA.’’
Dated: November 24, 2009.
Alexandra Huttinger,
Director, Division of Policy Review and
Coordination.
[FR Doc. E9–28696 Filed 11–30–09; 8:45 am]
BILLING CODE 4165–15–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0369] (formerly
Docket No. 2007D–0168)

Draft and Revised Draft Guidances for
Industry Describing Product-Specific
Bioequivalence Recommendations;
Availability
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice.

The Food and Drug
Administration (FDA) is announcing the
availability of additional draft and
revised draft product-specific
bioequivalence (BE) recommendations.
The recommendations provide productspecific guidance on the design of BE
studies to support abbreviated new drug
applications (ANDAs). In the Federal
Register of May 31, 2007, FDA
announced the availability of a draft
guidance for industry entitled
‘‘Bioequivalence Recommendations for
Specific Products,’’ explaining the
process that would be used to make
product-specific BE recommendations
available to the public on FDA’s Web
site. The BE recommendations
identified in this notice were developed
using the process described in that
guidance.

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SUMMARY:

DATES: Submit written or electronic
comments on the draft and revised draft

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62793

8
13
21

Responses
per respondent

Total
responses

396
4
........................

3,168
52
3,220

Hours
per response

Total
burden hours

0.50
0.75
........................

1,584
39
1,623

product-specific BE recommendations
listed in this notice by February 1, 2010.
ADDRESSES: Submit written requests for
single copies of the individual BE
guidances 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 selfaddressed adhesive label to assist that
office in processing your requests.
Submit written comments on the draft
product-specific BE recommendations
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to http://
www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
recommendations.
FOR FURTHER INFORMATION CONTACT:
Doan T. Nguyen, Center for Drug
Evaluation and Research (HFD–600),
Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240–
276–9314.
SUPPLEMENTARY INFORMATION:

Register. FDA considers any comments
received and either publishes final
recommendations, or publishes revised
draft recommendations for comment.
Recommendations were last announced
in the Federal Register of June 8, 2009
(74 FR 27146). This notice announces
draft product-specific
recommendations, either new or
revised, that have been posted on FDA’s
Web site in the period from November
1, 2008, through December 1, 2009.

I. Background
In the Federal Register of May 31,
2007 (72 FR 30388), FDA announced the
availability of a draft guidance for
industry entitled ‘‘Bioequivalence
Recommendations for Specific
Products,’’ that explained the process
that would be used to make productspecific BE recommendations available
to the public on FDA’s Web site at
http://www.fda.gov/CDER/GUIDANCE/
bioequivalence/default.htm. As
described in that draft guidance, FDA
adopted this process as a means to
develop and disseminate productspecific BE recommendations and
provide a meaningful opportunity for
the public to consider and comment on
those recommendations. Under that
process, draft recommendations are
posted on FDA’s Web site and
announced periodically in the Federal
Register. The public is encouraged to
submit comments on those
recommendations within 60 days of
their announcement in the Federal

B

PO 00000

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II. Drug Products for Which New Draft
Product-Specific BE Recommendations
Are Available
FDA is announcing draft BE productspecific recommendations for drug
products containing the following active
ingredients:

A
Adapalene (multiple reference listed drugs
(RLDs))
Adapalene; Benzoyl Peroxide
Alendronate Sodium; Cholecalciferol
Aliskiren Hemifumarate
Aliskiren Hemifumarate;
Hydrochlorothiazide
Allopurinol
Ambrisentan
Amlodipine Besylate; Atorvastatin Calcium
Atenolol
Bromfenac Sodium
Bromocriptine
Budesonide

C
Calcium Acetate
Cephalexin
Chlorpheniramine Polistirex; Hydrocodone
Polistirex
Ciprofloxacin
Clonidine
Clotrimazole (multiple RLDs)

D
Desmopressin Acetate
Desogestrel; Ethinyl Estradiol (multiple
RLDs)
Desvenlafaxine Succinate
Dextroamphetamine Sulfate
Dextromethorphan Hydrobromide;
Guaifenesin
Diclofenac Sodium (multiple RLDs)
Doxycycline Hyclate
Drospirenone; Ethinyl Estradiol

E
Eletriptan Hydrobromide

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