Agency Information Collection Activities: Proposed Collection: Comment Request, 16042-16043 [2012-6540]

Download as PDF 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 PO 00000 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: Frm 00050 Fmt 4703 Sfmt 4703 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
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