Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request, 5561-5562 [2015-01882]
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Federal Register / Vol. 80, No. 21 / Monday, February 2, 2015 / Notices
the ‘‘listed drug,’’ which is a version of
the drug that was previously approved.
ANDA applicants do not have to repeat
the extensive clinical testing otherwise
necessary to gain approval of a new
drug application (NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is generally known as the
‘‘Orange Book.’’ Under FDA regulations,
a drug is removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
Under § 314.161(a) (21 CFR
314.161(a)), the Agency must determine
whether a listed drug was withdrawn
from sale for reasons of safety or
effectiveness: (1) Before an ANDA that
refers to that listed drug may be
approved, (2) whenever a listed drug is
voluntarily withdrawn from sale and
ANDAs that refer to the listed drug have
been approved, and (3) when a person
petitions for such a determination under
21 CFR 10.25(a) and 10.30. Section
314.161(d) provides that if FDA
5561
determines that a listed drug was
withdrawn from sale for safety or
effectiveness reasons, the Agency will
initiate proceedings that could result in
the withdrawal of approval of the
ANDAs that refer to the listed drug.
FDA has become aware that the drug
products listed in the table in this
document are no longer being marketed.
(As requested by the applicants, FDA
withdrew approval of NDA 018310 for
LYMPHAZURIN (isosulfan blue)
Injectable in the Federal Register of
December 5, 2014 (79 FR 72186) and
NDA 020151 for EFFEXOR (venlafaxine
HCl) Tablets in the Federal Register of
July 19, 2013 (78 FR 43210).)
Application No.
Drug
Applicant
NDA 018310 .................
NDA 019966 .................
LYMPHAZURIN (isosulfan blue) Injectable; Injection, 1%
TEMOVATE (clobetasol propionate) Solution; Topical,
0.05%.
EFFEXOR (venlafaxine hydrochloride (HCl)) Tablet; Oral,
Equivalent to (EQ) 12.5 milligram (mg) Base; EQ 25
mg Base; EQ 37.5 mg Base; EQ 50 mg Base; EQ 75
mg Base; EQ 100 mg Base.
ZEMURON (rocuronium bromide) Injectable; Injection 100
mg/10 milliliter (mL); 50 mg/5 mL; 10 mg/mL.
PREFEST (estradiol; norgestimate) Tablet; Oral, 1 mg, 1
mg/0.09 mg.
CHILDREN’S ZYRTEC ALLERGY (cetirizine HCl) and
CHILDREN’S ZYRTEC HIVES RELIEF (cetirizine HCl)
Chewable Tablet; Oral, 5 mg; 10 mg.
PERIOSTAT (doxycycline hyclate) Tablet; Oral, EQ 20
mg Base.
Covidien, 60 Middletown Ave., North Haven, CT 06473.
Fougera Pharmaceuticals Inc., 1 Health Plaza, Bldg. 434,
East Hanover, NJ 07936.
Wyeth Pharmaceuticals Inc., 235 East 42nd St., New
York, NY 10017.
Dated: January 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
OMB will accept further comments from
the public during the review and
approval period.
DATES: Comments on this ICR should be
received no later than March 4, 2015.
ADDRESSES: Submit your comments,
including the Information Collection
Request Title, to the desk officer for
HRSA, either by email to OIRA_
submission@omb.eop.gov or by fax to
202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 443–1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Evaluation and Initial Assessment of the
HRSA Teaching Health Centers
Graduate Medical Education Program.
OMB No. 0906–xxxx—New.
Abstract: Section 5508 of the
Affordable Care Act of 2010 amended
section 340H of the Public Health
Service Act to establish the Teaching
Health Center Graduate Medical
Education (THCGME) program to
provide funding support for new and
NDA 020151 .................
NDA 020214 .................
NDA 021040 .................
NDA 021621 .................
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NDA 050783 .................
FDA has reviewed its records and,
under § 314.161, has determined that
the drug products listed in this
document were not withdrawn from
sale for reasons of safety or
effectiveness. Accordingly, the Agency
will continue to list the drug products
listed in this document in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
identifies, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness.
Approved ANDAs that refer to the
NDAs listed in this document are
unaffected by the discontinued
marketing of the products subject to
those NDAs. Additional ANDAs that
refer to these products may also be
approved by the Agency if they comply
with relevant legal and regulatory
requirements. If FDA determines that
labeling for these drug products should
be revised to meet current standards, the
Agency will advise ANDA applicants to
submit such labeling.
VerDate Sep<11>2014
19:24 Jan 30, 2015
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Organon USA Inc., 351 North Sunmeytown Pike, North
Wales, PA 19454.
Teva Branded Pharmaceutical Products R&D, Inc., 41
Moores Rd., P.O. Box 4011, Frazer, PA 19355.
McNeil Consumer Healthcare, 7050 Camp Hill Rd., Fort
Washington, PA 19034.
Galderma Laboratories, L.P., 14501 North Freeway, Fort
Worth, TX 76177.
[FR Doc. 2015–01859 Filed 1–30–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health
Resources and Services Administration
(HRSA) has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
SUMMARY:
PO 00000
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5562
Federal Register / Vol. 80, No. 21 / Monday, February 2, 2015 / Notices
the expansion of existing primary care
residency training programs in
community-based settings. The primary
goals of this program are to increase the
production of primary care providers
who are better prepared to practice in
community settings, particularly with
underserved populations, and improve
the geographic distribution of primary
care providers.
Statute requires the Secretary to
determine an appropriate THCGME
program payment for indirect medical
expenses (IME) as well as to update, as
deemed appropriate, the per resident
amount used to determine the Program’s
payment for direct medical expenses
(DME). To inform these determinations
and to increase understanding of this
model of residency training, the George
Washington University (GW) is
conducting an evaluation of the costs
associated with training residents in the
Teaching Health Center (THC) model.
GW has developed a standardized
costing instrument to gather data from
all THCGME programs. The information
gathered in the standardized costing
instrument includes, but is not limited
to, resident and faculty full-time
equivalents, salaries and benefits,
residency administration costs,
educational costs, residency clinical
operations and administrative costs, and
patient visits and clinical revenue
generated by medical residents.
Need and Proposed Use of the
Information: HRSA is collecting costing
information related to both DME and
IME in an effort to establish a THC’s
total cost of running a residency
program, to assist the Secretary in
determining an appropriate update to
the per resident amount used to
calculate the payment for DME and an
appropriate IME payment. The
described data collection activities will
serve to inform these statutory
requirements for the Secretary in a
uniform and consistent manner.
Likely Respondents: THCGME
grantees.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
Teaching Health Center Costing Instrument .......................
60
1
60
10
600
Total ..............................................................................
60
1
60
10
600
Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2015–01882 Filed 1–30–15; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
[CFDA Number: 93.164]
Loan Repayment Program for
Repayment of Health Professions
Educational Loans Announcement
Type: Initial
Key Dates: February 13, 2015
first award cycle deadline date; August
14, 2015 last award cycle deadline date;
September 11, 2015 last award cycle
deadline date for supplemental loan
repayment program funds; September
30, 2015 entry on duty deadline date.
mstockstill on DSK4VPTVN1PROD with NOTICES
DATES:
I. Funding Opportunity Description
The Indian Health Service (IHS)
estimated budget request for Fiscal Year
(FY) 2015 includes $16,721,135 for the
IHS Loan Repayment Program (LRP) for
health professional educational loans
(undergraduate and graduate) in return
for full-time clinical service as defined
VerDate Sep<11>2014
19:24 Jan 30, 2015
Jkt 235001
in the IHS LRP policy clarifications at
https://www.ihs.gov/loanrepayment/
documents/LRP_Policy_Updates.pdf in
Indian health programs.
This program announcement is
subject to the appropriation of funds.
This notice is being published early to
coincide with the recruitment activity of
the IHS which competes with other
Government and private health
management organizations to employ
qualified health professionals.
This program is authorized by the
Indian Health Care Improvement Act
(IHCIA) Section 108, codified at 25
U.S.C. 1616a.
II. Award Information
The estimated amount available is
approximately $16,721,135 to support
approximately 387 competing awards
averaging $43,182 per award for a two
year contract. One year contract
extensions will receive priority
consideration in any award cycle.
Applicants selected for participation in
the FY 2015 program cycle will be
expected to begin their service period
no later than September 30, 2015.
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
III. Eligibility Information
A. Eligible Applicants
Pursuant to 25 U.S.C. 1616(b), to be
eligible to participate in the LRP, an
individual must:
(1)(A) Be enrolled —
(i) In a course of study or program in an
accredited institution, as determined by the
Secretary, within any State and be scheduled
to complete such course of study in the same
year such individual applies to participate in
such program; or
(ii) In an approved graduate training
program in a health profession; or
(B) Have a degree in a health profession
and a license to practice in a State; and
(2)(A) Be eligible for, or hold an
appointment as a commissioned officer in the
Regular Corps of the Public Health Service
(PHS); or
(B) Be eligible for selection for service in
the Regular Corps of the PHS; or
(C) Meet the professional standards for
civil service employment in the IHS; or
(D) Be employed in an Indian health
program without service obligation; and
(E) Submit to the Secretary an application
for a contract to the LRP. The Secretary must
approve the contract before the disbursement
of loan repayments can be made to the
participant. Participants will be required to
fulfill their contract service agreements
through full-time clinical practice at an
Indian health program site determined by the
E:\FR\FM\02FEN1.SGM
02FEN1
]]>Agencies
[Federal Register Volume 80, Number 21 (Monday, February 2, 2015)]
[Notices]
[Pages 5561-5562]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01882]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment Request
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health Resources and Services Administration
(HRSA) has submitted an Information Collection Request (ICR) to the
Office of Management and Budget (OMB) for review and approval. Comments
submitted during the first public review of this ICR will be provided
to OMB. OMB will accept further comments from the public during the
review and approval period.
DATES: Comments on this ICR should be received no later than March 4,
2015.
ADDRESSES: Submit your comments, including the Information Collection
Request Title, to the desk officer for HRSA, either by email to
OIRA_submission@omb.eop.gov or by fax to 202-395-5806.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email the HRSA Information
Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443-
1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: Evaluation and Initial
Assessment of the HRSA Teaching Health Centers Graduate Medical
Education Program.
OMB No. 0906-xxxx--New.
Abstract: Section 5508 of the Affordable Care Act of 2010 amended
section 340H of the Public Health Service Act to establish the Teaching
Health Center Graduate Medical Education (THCGME) program to provide
funding support for new and
[[Page 5562]]
the expansion of existing primary care residency training programs in
community-based settings. The primary goals of this program are to
increase the production of primary care providers who are better
prepared to practice in community settings, particularly with
underserved populations, and improve the geographic distribution of
primary care providers.
Statute requires the Secretary to determine an appropriate THCGME
program payment for indirect medical expenses (IME) as well as to
update, as deemed appropriate, the per resident amount used to
determine the Program's payment for direct medical expenses (DME). To
inform these determinations and to increase understanding of this model
of residency training, the George Washington University (GW) is
conducting an evaluation of the costs associated with training
residents in the Teaching Health Center (THC) model. GW has developed a
standardized costing instrument to gather data from all THCGME
programs. The information gathered in the standardized costing
instrument includes, but is not limited to, resident and faculty full-
time equivalents, salaries and benefits, residency administration
costs, educational costs, residency clinical operations and
administrative costs, and patient visits and clinical revenue generated
by medical residents.
Need and Proposed Use of the Information: HRSA is collecting
costing information related to both DME and IME in an effort to
establish a THC's total cost of running a residency program, to assist
the Secretary in determining an appropriate update to the per resident
amount used to calculate the payment for DME and an appropriate IME
payment. The described data collection activities will serve to inform
these statutory requirements for the Secretary in a uniform and
consistent manner.
Likely Respondents: THCGME grantees.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install and utilize technology and
systems for the purpose of collecting, validating and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information; to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this ICR are summarized in the table below.
Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Teaching Health Center Costing 60 1 60 10 600
Instrument.....................
-------------------------------------------------------------------------------
Total....................... 60 1 60 10 600
----------------------------------------------------------------------------------------------------------------
Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2015-01882 Filed 1-30-15; 8:45 am]
BILLING CODE 4165-15-P
