Agency Information Collection Activities: Proposed Collection: Comment Request, 16042-16043 [2012-6540]
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16042
Federal Register / Vol. 77, No. 53 / Monday, March 19, 2012 / Notices
TABLE 1—Continued
Application No.
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
088272
088273
088456
088493
088850
088907
......................
......................
......................
......................
......................
......................
ANDA
ANDA
ANDA
ANDA
ANDA
088933
088934
089135
089136
089173
......................
......................
......................
......................
......................
ANDA 089174 ......................
ANDA
ANDA
ANDA
ANDA
089207
089208
089209
089457
......................
......................
......................
......................
ANDA 089602 ......................
ANDA 089603 ......................
ANDA 089624 ......................
ANDA 089657 ......................
ANDA 089708 ......................
Drug
Applicant
Thioridazine HCl Tablets USP, 25 mg ............................
Thioridazine HCl Tablets USP, 100 mg ..........................
Thioridazine HCl Tablets USP, 100 mg ..........................
Thioridazine HCl Tablets USP, 10 mg ............................
Hydroflumethiazide Tablets USP, 50 mg ........................
Reserpine and Hydroflumethiazide Tablets, 0.125 mg/
50 mg.
Sulfinpyrazone Tablets, 100 mg .....................................
Sulfinpyrazone Capsules USP, 200 mg .........................
Methyclothiazide Tablets, 2.5 mg ...................................
Methyclothiazide Tablets, 5 mg ......................................
A–MethaPred (methylprednisolone sodium succinate for
injection USP), 500 mg (base)/Vial.
A–MethaPred (methylprednisolone sodium succinate for
injection USP), 1 gram (base)/Vial.
Methylprednisolone Tablets USP, 16 mg .......................
Methylprednisolone Tablets USP, 24 mg .......................
Methylprednisolone Tablets USP, 32 mg .......................
Perphenazine Tablets USP, 16 mg ................................
Thioridazine HCl Oral Solution USP, 30 mg/mL ............
Thioridazine HCl Oral Solution USP, 100 mg/mL ..........
Reversol (edrophonium chloride injection USP), 10 mg/
mL).
Methocarbamol and Aspirin Tablets, 400 mg/325 mg ....
Perphenazine Tablets USP, 4 mg ..................................
Do.
Do.
Teva Pharmaceuticals USA.
Do.
Par Pharmaceutical, Inc.
Do.
Do.
Do.
Do.
Do.
Hospira, Inc.
Do.
Par Pharmaceutical, Inc.
Do.
Do.
Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA.
Teva Pharmaceuticals USA.
Do.
Organon USA Inc.
Par Pharmaceutical, Inc.
Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA.
1 This product included an oral pressurized metered-dose inhaler that contained chlorofluorocarbons (CFCs) as a propellant. CFCs may no
longer be used as a propellant for any albuterol or salmeterol metered-dose inhalers (see 70 FR 17168, April 4, 2005; 71 FR 70870, December
7, 2006).
emcdonald on DSK29S0YB1PROD with NOTICES
Therefore, under section 505(e) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 355(e)) and under
authority delegated to the Director,
Center for Drug Evaluation and
Research, by the Commissioner,
approval of the applications listed in
table 1 in this document, and all
amendments and supplements thereto,
is hereby withdrawn, effective April 18,
2012. Introduction or delivery for
introduction into interstate commerce of
products without approved new drug
applications violates section 301(a) and
(d) of the FD&C Act (21 U.S.C. 331(a)
and (d)). Drug products that are listed in
table 1 in this document that are in
inventory on the date that this notice
becomes effective (see the DATES
section) may continue to be dispensed
until the inventories have been depleted
or the drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
Dated: February 16, 2012.
Janet Woodcock,
Director, Center for Drug Evaluation and
Research.
[FR Doc. 2012–6591 Filed 3–16–12; 8:45 am]
BILLING CODE 4160–01–P
VerDate Mar<15>2010
13:40 Mar 16, 2012
Jkt 226001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and draft instruments, email
paperwork@hrsa.gov or call the HRSA
Reports Clearance Officer at (301) 443–
1984.
Comments are invited on: (a) The
proposed collection of information for
the proper performance of the functions
of the agency; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
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.
Proposed Project: Enrollment and ReCertification of Entities in the 340B
Drug Pricing Program (OMB No. 0915–
0327)—Revision
Section 602 of Public Law 102–585,
the Veterans Health Care Act of 1992,
enacted section 340B of the Public
Health Service Act (PHS Act)
‘‘Limitation on Prices of Drugs
Purchased by Covered Entities.’’ Section
340B provides that a manufacturer who
sells covered outpatient drugs to eligible
entities must sign a pharmaceutical
pricing agreement with the Secretary of
Health and Human Services in which
the manufacturer agrees to charge a
price for covered outpatient drugs that
will not exceed an amount determined
under a statutory formula.
Covered entities which choose to
participate in the section 340B Drug
Pricing Program must comply with the
requirements of section 340B(a)(5) of the
PHS Act. Section 340B(a)(5)(A)
prohibits a covered entity from
accepting a discount for a drug that
would also generate a Medicaid rebate.
E:\FR\FM\19MRN1.SGM
19MRN1
16043
Federal Register / Vol. 77, No. 53 / Monday, March 19, 2012 / Notices
Further, section 340B(a)(5)(B) prohibits
a covered entity from reselling or
otherwise transferring a discounted drug
to a person who is not a patient of the
entity.
In response to the statutory mandate
of section 340B(a)(9) of the PHS Act to
notify manufacturers of the identities of
covered entities and the mandate of
section 340B(a)(5)(A)(ii) to establish a
mechanism to ensure against duplicate
discounts and the ongoing
responsibility to administer the 340B
Drug Pricing Program while maintaining
efficiency, transparency and integrity,
the HRSA Office of Pharmacy Affairs
(OPA) developed a process of
registration of covered entities to enable
it to address those mandates.
Enrollment/Registration
To enroll and certify the eligible
federally funded grantees and other
safety net health care providers, OPA
requires entities to submit
administrative information (e.g.,
shipping and billing arrangements,
Medicaid participation), certifying
information and signatures from
appropriate grantee level or entity level
authorizing officials and state/local
government representatives. The
purpose of this registration information
is to determine eligibility for the 340B
Drug Pricing Program. This information
is entered into the 340B database by
entities and verified by OPA staff
according to 340B Drug Pricing Program
requirements. Accurate records are
critical to implementation of the 340B
Drug Pricing Program, especially to
prevent drug diversion to non-eligible
individuals as well as duplicate
discounts from manufacturers. To
maintain accurate records, OPA also
requires that entities recertify eligibility
Number of
respondents
Reporting requirement
Responses
per
respondent
annually and that they notify the
program of updates to any
administrative information that they
submitted when initially enrolling into
the program. The burden requirement
for these processes is low for
recertification and minimal for
submitting change requests.
Contract Pharmacy Self-Certification
In order to ensure that drug
manufacturers and drug wholesalers
recognize contract pharmacy
arrangements, covered entities that elect
to utilize one or more contract
pharmacies are also required to submit
general information about the
arrangements and certifications that
signed agreements are in place with
those contract pharmacies.
The annual estimate of burden is as
follows:
Total
responses
Hours per
response
Total burden
hours
Hospital Enrollment, Additions & Recertifications
340B Program Registrations & Certifications for Hospitals
Certifications to Enroll Hospital Outpatient Facilities ...........
Hospital Annual Recertifications ..........................................
546
606
4842
1
1
1
546
606
4842
2.0
.50
.50
1092
303
2421
Registrations and Recertifications for Entities Other Than Hospitals
340B Registrations for Community Health Centers ............
340B Registrations for Family Planning Programs, STD/TB
Clinics and Various Other Eligible Entity Types ..............
Community Health Center Annual Recertifications .............
Family Planning Annual Recertifications .............................
STD & TB Annual Recertifications ......................................
Annual Recertification for Entities other than Hospitals,
Community Health Centers, Family Planning, STD or TB
Clinics ...............................................................................
253
1
253
1.0
253
353
4507
3879
2754
1
1
1
1
353
4507
3879
2754
1.0
.50
.50
.50
353
2253.5
1939.5
1377
1174
1
1174
.50
587
2500
1
2500
.50
1250
350
1
350
.50
175
2500
24,264
1.0
........................
2500
14,504
Other Information Collections
Submission of Administrative Changes for any Covered
Entity .................................................................................
Submission of Administrative Changes for any Manufacturer ..................................................................................
Contracted Pharmacy Services Registration & Recertifications
emcdonald on DSK29S0YB1PROD with NOTICES
Contracted Pharmacy Services Registration .......................
Total ..............................................................................
Email comments to
paperwork@hrsa.gov or mail the HRSA
Reports Clearance Officer, Room 10–29,
Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857. Written comments
should be received within 60 days of
this notice.
VerDate Mar<15>2010
13:40 Mar 16, 2012
Jkt 226001
2500
24,264
1
........................
Dated: March 13, 2012.
Reva Harris,
Acting Director, Division of Policy and
Information Coordination.
[FR Doc. 2012–6540 Filed 3–16–12; 8:45 am]
BILLING CODE 4165–15–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Public Hearing
The National Institutes of
Health (NIH) will hold a public meeting
on Thursday, April 19, 2012, from 6:30–
9:30 p.m. at Roxbury Community
College, Main Stage, 1234 Columbus
Avenue, Boston, MA 02120. The
SUMMARY:
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E:\FR\FM\19MRN1.SGM
19MRN1
Agencies
[Federal Register Volume 77, Number 53 (Monday, March 19, 2012)]
[Notices]
[Pages 16042-16043]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-6540]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Comment Request
In compliance with the requirement for opportunity for public
comment on proposed data collection projects (section 3506(c)(2)(A) of
Title 44, United States Code, as amended by the Paperwork Reduction Act
of 1995, Pub. L. 104-13), the Health Resources and Services
Administration (HRSA) publishes periodic summaries of proposed projects
being developed for submission to the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995. To request more
information on the proposed project or to obtain a copy of the data
collection plans and draft instruments, email paperwork@hrsa.gov or
call the HRSA Reports Clearance Officer at (301) 443-1984.
Comments are invited on: (a) The proposed collection of information
for the proper performance of the functions of the agency; (b) the
accuracy of the agency's estimate of the burden of the proposed
collection of information; (c) ways to enhance 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.
Proposed Project: Enrollment and Re-Certification of Entities in the
340B Drug Pricing Program (OMB No. 0915-0327)--Revision
Section 602 of Public Law 102-585, the Veterans Health Care Act of
1992, enacted section 340B of the Public Health Service Act (PHS Act)
``Limitation on Prices of Drugs Purchased by Covered Entities.''
Section 340B provides that a manufacturer who sells covered outpatient
drugs to eligible entities must sign a pharmaceutical pricing agreement
with the Secretary of Health and Human Services in which the
manufacturer agrees to charge a price for covered outpatient drugs that
will not exceed an amount determined under a statutory formula.
Covered entities which choose to participate in the section 340B
Drug Pricing Program must comply with the requirements of section
340B(a)(5) of the PHS Act. Section 340B(a)(5)(A) prohibits a covered
entity from accepting a discount for a drug that would also generate a
Medicaid rebate.
[[Page 16043]]
Further, section 340B(a)(5)(B) prohibits a covered entity from
reselling or otherwise transferring a discounted drug to a person who
is not a patient of the entity.
In response to the statutory mandate of section 340B(a)(9) of the
PHS Act to notify manufacturers of the identities of covered entities
and the mandate of section 340B(a)(5)(A)(ii) to establish a mechanism
to ensure against duplicate discounts and the ongoing responsibility to
administer the 340B Drug Pricing Program while maintaining efficiency,
transparency and integrity, the HRSA Office of Pharmacy Affairs (OPA)
developed a process of registration of covered entities to enable it to
address those mandates.
Enrollment/Registration
To enroll and certify the eligible federally funded grantees and
other safety net health care providers, OPA requires entities to submit
administrative information (e.g., shipping and billing arrangements,
Medicaid participation), certifying information and signatures from
appropriate grantee level or entity level authorizing officials and
state/local government representatives. The purpose of this
registration information is to determine eligibility for the 340B Drug
Pricing Program. This information is entered into the 340B database by
entities and verified by OPA staff according to 340B Drug Pricing
Program requirements. Accurate records are critical to implementation
of the 340B Drug Pricing Program, especially to prevent drug diversion
to non-eligible individuals as well as duplicate discounts from
manufacturers. To maintain accurate records, OPA also requires that
entities recertify eligibility annually and that they notify the
program of updates to any administrative information that they
submitted when initially enrolling into the program. The burden
requirement for these processes is low for recertification and minimal
for submitting change requests.
Contract Pharmacy Self-Certification
In order to ensure that drug manufacturers and drug wholesalers
recognize contract pharmacy arrangements, covered entities that elect
to utilize one or more contract pharmacies are also required to submit
general information about the arrangements and certifications that
signed agreements are in place with those contract pharmacies.
The annual estimate of burden is as follows:
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Reporting requirement respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
Hospital Enrollment, Additions & Recertifications
----------------------------------------------------------------------------------------------------------------
340B Program Registrations & 546 1 546 2.0 1092
Certifications for Hospitals...
Certifications to Enroll 606 1 606 .50 303
Hospital Outpatient Facilities.
Hospital Annual Recertifications 4842 1 4842 .50 2421
----------------------------------------------------------------------------------------------------------------
Registrations and Recertifications for Entities Other Than Hospitals
----------------------------------------------------------------------------------------------------------------
340B Registrations for Community 253 1 253 1.0 253
Health Centers.................
340B Registrations for Family 353 1 353 1.0 353
Planning Programs, STD/TB
Clinics and Various Other
Eligible Entity Types..........
Community Health Center Annual 4507 1 4507 .50 2253.5
Recertifications...............
Family Planning Annual 3879 1 3879 .50 1939.5
Recertifications...............
STD & TB Annual Recertifications 2754 1 2754 .50 1377
Annual Recertification for 1174 1 1174 .50 587
Entities other than Hospitals,
Community Health Centers,
Family Planning, STD or TB
Clinics........................
----------------------------------------------------------------------------------------------------------------
Other Information Collections
----------------------------------------------------------------------------------------------------------------
Submission of Administrative 2500 1 2500 .50 1250
Changes for any Covered Entity.
Submission of Administrative 350 1 350 .50 175
Changes for any Manufacturer...
----------------------------------------------------------------------------------------------------------------
Contracted Pharmacy Services Registration & Recertifications
----------------------------------------------------------------------------------------------------------------
Contracted Pharmacy Services 2500 1 2500 1.0 2500
Registration...................
Total....................... 24,264 .............. 24,264 .............. 14,504
----------------------------------------------------------------------------------------------------------------
Email comments to paperwork@hrsa.gov or mail the HRSA Reports
Clearance Officer, Room 10-29, Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857. Written comments should be received within 60 days
of this notice.
Dated: March 13, 2012.
Reva Harris,
Acting Director, Division of Policy and Information Coordination.
[FR Doc. 2012-6540 Filed 3-16-12; 8:45 am]
BILLING CODE 4165-15-P