[Federal Register Volume 77, Number 53 (Monday, March 19, 2012)]
[Notices]
[Pages 16042-16043]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-6540]


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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 [email protected] 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:

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                                     Number of     Responses per       Total         Hours per     Total burden
      Reporting requirement         respondents     respondent       responses       response          hours
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                                Hospital Enrollment, Additions & Recertifications
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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
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                      Registrations and Recertifications for Entities Other Than Hospitals
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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........................
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                                          Other Information Collections
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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...
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                          Contracted Pharmacy Services Registration & Recertifications
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Contracted Pharmacy Services                2500               1            2500             1.0            2500
 Registration...................
    Total.......................          24,264  ..............          24,264  ..............          14,504
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    Email comments to [email protected] 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