16042 Federal Register / Vol. 77, No. 53 / Monday, March 19, 2012 / Notices 

TABLE 1—Continued 

Application No. Drug Applicant 

ANDA 088272 ...................... Thioridazine HCl Tablets USP, 25 mg ............................ Do. 

ANDA 088273 ...................... Thioridazine HCl Tablets USP, 100 mg .......................... Do. 

ANDA 088456 ...................... Thioridazine HCl Tablets USP, 100 mg .......................... Teva Pharmaceuticals USA. 

ANDA 088493 ...................... Thioridazine HCl Tablets USP, 10 mg ............................ Do. 

ANDA 088850 ...................... Hydroflumethiazide Tablets USP, 50 mg ........................ Par Pharmaceutical, Inc. 

ANDA 088907 ...................... Reserpine and Hydroflumethiazide Tablets, 0.125 mg/ 

50 mg.

Do. 

ANDA 088933 ...................... Sulfinpyrazone Tablets, 100 mg ..................................... Do. 

ANDA 088934 ...................... Sulfinpyrazone Capsules USP, 200 mg ......................... Do. 

ANDA 089135 ...................... Methyclothiazide Tablets, 2.5 mg ................................... Do. 

ANDA 089136 ...................... Methyclothiazide Tablets, 5 mg ...................................... Do. 

ANDA 089173 ...................... A–MethaPred (methylprednisolone sodium succinate for 

injection USP), 500 mg (base)/Vial.

Hospira, Inc. 

ANDA 089174 ...................... A–MethaPred (methylprednisolone sodium succinate for 

injection USP), 1 gram (base)/Vial.

Do. 

ANDA 089207 ...................... Methylprednisolone Tablets USP, 16 mg ....................... Par Pharmaceutical, Inc. 

ANDA 089208 ...................... Methylprednisolone Tablets USP, 24 mg ....................... Do. 

ANDA 089209 ...................... Methylprednisolone Tablets USP, 32 mg ....................... Do. 

ANDA 089457 ...................... Perphenazine Tablets USP, 16 mg ................................ Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA. 

ANDA 089602 ...................... Thioridazine HCl Oral Solution USP, 30 mg/mL ............ Teva Pharmaceuticals USA. 

ANDA 089603 ...................... Thioridazine HCl Oral Solution USP, 100 mg/mL .......... Do. 

ANDA 089624 ...................... Reversol (edrophonium chloride injection USP), 10 mg/ 

mL).

Organon USA Inc. 

ANDA 089657 ...................... Methocarbamol and Aspirin Tablets, 400 mg/325 mg .... Par Pharmaceutical, Inc. 

ANDA 089708 ...................... Perphenazine Tablets USP, 4 mg .................................. Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA. 

1This 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). 

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 

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 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. 


emcdonald on DSK29S0YB1PROD with NOTICES
Federal Register / Vol. 77, No. 53 / Monday, March 19, 2012 / Notices 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: 

Reporting requirement Number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Hours per 

response 

Total burden 

hours 

Hospital Enrollment, Additions & Recertifications 

340B Program Registrations & Certifications for Hospitals 546 1 546 2.0 1092 

Certifications to Enroll Hospital Outpatient Facilities ........... 606 1 606 .50 303 

Hospital Annual Recertifications .......................................... 4842 1 4842 .50 2421 

Registrations and Recertifications for Entities Other Than Hospitals 

340B Registrations for Community Health Centers ............ 253 1 253 1.0 253 

340B Registrations for Family Planning Programs, STD/TB 

Clinics and Various Other Eligible Entity Types .............. 353 1 353 1.0 353 

Community Health Center Annual Recertifications ............. 4507 1 4507 .50 2253.5 

Family Planning Annual Recertifications ............................. 3879 1 3879 .50 1939.5 

STD & TB Annual Recertifications ...................................... 2754 1 2754 .50 1377 

Annual Recertification for Entities other than Hospitals, 

Community Health Centers, Family Planning, STD or TB 

Clinics ............................................................................... 1174 1 1174 .50 587 

Other Information Collections 

Submission of Administrative Changes for any Covered 

Entity ................................................................................. 2500 1 2500 .50 1250 

Submission of Administrative Changes for any Manufacturer .................................................................................. 350 1 350 .50 175 

Contracted Pharmacy Services Registration & Recertifications 

Contracted Pharmacy Services Registration ....................... 2500 1 2500 1.0 2500 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Public Hearing 

SUMMARY: 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 


emcdonald on DSK29S0YB1PROD with NOTICES