[Federal Register Volume 87, Number 114 (Tuesday, June 14, 2022)]
[Notices]
[Pages 35983-35985]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-12776]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration

[OMB Number 0915-0327--Revision]


Agency Information Collection Activities: Proposed Collection: 
Public Comment Request Information Collection Request Title: Enrollment 
and Re-Certification of Entities in the 340B Drug Pricing Program

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: In compliance with the requirement for opportunity for public 
comment on proposed data collection projects of the Paperwork Reduction 
Act of 1995, HRSA announces plans to submit an Information Collection 
Request (ICR), described below, to the Office of Management and Budget 
(OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the 
public regarding the burden estimate, below, or any other aspect of the 
ICR.

DATES: Comments on this ICR should be received no later than August 15, 
2022.

ADDRESSES: Submit your comments to [email protected] or by mail to the 
HRSA Information Collection Clearance Officer, Room 14N136B, 5600 
Fishers Lane, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: 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 Samantha Miller, 
the acting HRSA Information Collection Clearance Officer at (301) 443-
9094.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the information collection request title 
for reference.
    Information Collection Request Title: Enrollment and Re-
Certification of Entities in the 340B Drug Pricing Program, OMB No. 
0915-0327--Revision.
    Abstract: Section 602 of Public Law 102-585, the Veterans Health 
Care Act of 1992, enacted section 340B of the Public Health Service 
(PHS) Act, which instructs HHS to enter into a Pharmaceutical Pricing 
Agreement (PPA) with manufacturers of covered outpatient drugs. 
Manufacturers are required by section 1927(a)(5)(A) of the Social 
Security Act to enter into agreements with the Secretary of HHS 
(Secretary) that comply with section 340B of the PHS Act if they 
participate in the Medicaid Drug Rebate Program. When a drug 
manufacturer signs a PPA, it is opting into the 340B Drug Pricing 
Program (340B Program), and it agrees to the statutory requirement that 
prices charged for covered outpatient drugs to covered entities will 
not exceed statutorily defined 340B ceiling prices. When an eligible 
covered entity voluntarily decides to enroll and participate in the 
340B Program, it accepts responsibility for ensuring compliance with 
all provisions of the 340B Program, including all associated costs. 
Covered entities that choose to participate in the 340B Program must 
comply with the requirements of section 340B(a)(5) of the PHS Act. 
Section 340B(a)(5)(A) of the PHS Act prohibits a covered entity from 
accepting a discount for a drug that would also generate a Medicaid 
rebate. Further, section 340B(a)(5)(B) of the PHS Act prohibits a 
covered entity from reselling or otherwise transferring a discounted 
drug to a person who is not a patient of the covered entity.
    Need and Proposed Use of the Information: To ensure the ongoing 
responsibility to administer the 340B Program while maintaining 
efficiency, transparency and integrity, HRSA developed a process of 
registration for covered entities to enable it to address specific 
statutory mandates. Specifically, section 340B(a)(9) of the PHS Act 
requires HRSA to notify manufacturers of the identities of covered 
entities and of their status pertaining to certification and annual 
recertification in the 340B Program pursuant to section 340B(a)(7) and 
the establishment of a mechanism to prevent duplicate discounts as 
outlined at section 340B(a)(5)(A)(ii) of the PHS Act.
    In addition, section 340B(a)(1) of the PHS Act requires each 
participating manufacturer to enter into an agreement with the 
Secretary in order to offer covered outpatient drugs to 340B covered 
entities.
    Finally, section 340B(d)(1)(B)(i) of the PHS Act requires the 
development of a system to enable the Secretary to verify the accuracy 
of ceiling prices calculated by manufacturers under subsection (a)(1) 
and charged to covered entities.
    HRSA is requesting approval for existing information collections. 
HRSA notes that the previously approved collections are mostly 
unchanged, except some of the forms have been revised to increase 
program efficiency and integrity. Below are descriptions of each of the 
forms and any resulting revisions that are captured in both the 
registration and pricing component of the 340B Office of Pharmacy 
Affairs Information System (OPAIS).

Enrollment/Registration/Recertification

    To enroll and certify the eligibility of federally funded grantees 
and other safety net health care providers, HRSA requires covered 
entities to submit administrative information (e.g., shipping and 
billing arrangements, Medicaid participation), certifying information 
(e.g., Medicare Cost Report information, documentation supporting the 
hospital's selected classification) and attestation from appropriate 
grantee level or entity level authorizing officials and primary 
contacts. To maintain accurate records, HRSA requests entities to 
submit modifications to any administrative information that they 
submitted when initially enrolling into the Program. Covered entities 
participating in the 340B Program have an ongoing responsibility to 
immediately notify HRSA in the event of any change in eligibility for 
the 340B Program. No less than on an annual basis, covered entities 
need to certify the accuracy of the information provided and continued 
maintenance of their eligibility and to comply with statutory mandates 
of the Program.
    Registration and annual recertification information is entered into 
the 340B OPAIS by covered entities and verified by HRSA staff according 
to 340B Program requirements. The following forms are being revised:
    1. 340B Program Registrations & Recertifications for Hospitals 
(applies to all hospital types): In September 2017, HRSA launched 340B 
OPAIS, which

[[Page 35984]]

among other things, removed the attestation requirement from the 
Government Official for the classification of a parent hospital, but it 
was still required for the covered entity to enter the Government 
Official contact information. As covered entities are no longer 
required to obtain this attestation, HRSA is removing the requirement 
for the covered entity to enter the Government Official contact 
information in 340B OPAIS. This will not change the burden on the 
entities.
    2. 340B Registrations & Recertifications for Ryan White Entities: 
Previously, HRSA requested that any Ryan White entity provide its 
Notice of Funding Opportunity (NOFO) number at the time of registration 
and recertification. After reevaluation, HRSA has determined that the 
NOFO number is an unnecessary component to determine the eligibility of 
a Ryan White entity's registration. Since the NOFO number correlates to 
the Ryan White entity's Federal Grant Number, which is already required 
to be entered in 340B OPAIS during registration, the NOFO number is not 
needed. This will not change the burden on the covered entities.
    3. 340B Registration, Recertification & Change Requests for 
Shipping Address: HRSA is providing additional clarification for 
covered entities to complete the shipping address section in 340B OPAIS 
to assist in determining the exact shipping address location and 
relationship to the covered entity. This clarification will not change 
burden on entities.
    4. 340B Program Registrations, Recertifications & Change Requests 
for Hospitals (applies to rural referral centers and sole community 
hospital entity types): HRSA is revising the 340B OPAIS registration 
for the rural referral centers and sole community hospital types, in an 
effort to provide guidance that determines the eligibility criteria. If 
applicable, 340B OPAIS will prompt the covered entity for documentation 
that supports eligibility, which will be attached as part of its 
registration, recertification or change request submission. Currently, 
the request for the supporting eligibility documentation is obtained 
during the submission review process; therefore, this requirement would 
not change the burden on the entities.
    5. 340B Program Change Requests for Hospitals: HRSA will allow 
hospital qualification information such as, the Disproportionate Share 
Adjustment Percentage, control type, hospital classification, and 
contract start date, to be changed under a change request submission as 
well as during recertification. This requirement would not change the 
burden on the entities, as this is an option to change the information 
by the hospital.
    6. 340B Primary Contact and Authorizing Official Information: HRSA 
removed the FAX number field. This does not change the burden on 
covered entities, as this was an optional field.
    7. 340B Program Recertifications & Change Requests for Hospitals: 
HRSA is clarifying when the covered entity would initiate a name change 
in 340B OPAIS. If applicable, 340B OPAIS will prompt the covered entity 
for documentation that supports the name change, which will be attached 
as part of its recertification or change request submission. Currently, 
the request for the supporting name change documentation is obtained 
during the submission review process, therefore, this requirement would 
not change the burden on covered entities.

Contract Pharmacy 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 required to submit 
general information about their contract pharmacy arrangements and 
certify that signed agreements are in place with those contract 
pharmacies. There is no change in burden on the entities.

Pharmaceutical Pricing Agreement and Addendum

    In accordance with the 340B Program guidance issued in the May 7, 
1993, Federal Register, section 340B(a)(1) of the PHS Act provides that 
a manufacturer who sells covered outpatient drugs to eligible entities 
must sign a Pharmaceutical Pricing Agreement (the ``Agreement'') with 
the Secretary of Health and Human Services (the ``Secretary'') in which 
the manufacturer agrees to charge a price for covered outpatient drugs 
that will not exceed the average manufacturer price (``AMP'') decreased 
by a rebate percentage. In addition, section 340B(a)(1) of the PHS Act 
includes specific required components of the PPA with manufacturers of 
covered outpatient drugs. In particular, section 340B(a)(1) includes 
the following requirements:
    I. ``Each such agreement shall require that the manufacturer 
furnish the Secretary with reports, on a quarterly basis, of the price 
for each covered outpatient drug subject to the agreement that, 
according to the manufacturer, represents the maximum price that 
covered entities may permissibly be required to pay for the drug 
(referred to in this section as the ``ceiling price'') and
    II. ``. . . shall require that the manufacturer offer each covered 
entity covered outpatient drugs for purchase at or below the applicable 
ceiling price if such drug is made available to any other purchaser at 
any price.''
    The burden imposed on manufacturers by submission of the PPA and 
PPA Addendum is low as the information is readily available.

Pricing Data Submission, Validation and Dissemination

    In order to implement section 340B(d)(1)(B)(i)(II) of the PHS Act, 
HRSA developed a system to calculate 340B ceiling prices prospectively 
from data obtained from the Centers for Medicare & Medicaid Services as 
well as a third party commercial database. However, in order to conduct 
the comparison required under the statute, manufacturers must submit 
the quarterly pricing data as required by section 340B(d)(1)(B)(i)(II). 
The 340B OPAIS securely collects the following data from manufacturers 
on a quarterly basis: AMP, unit rebate amount, package size, case pack 
size, unit type, national drug code, labeler code, product code, period 
of sale (year and quarter), FDA product name, labeler name, wholesale 
acquisition cost, and the manufacturer determined ceiling price for 
each covered outpatient drug produced by a manufacturer subject to a 
PPA. The burden imposed on manufacturers is low because the information 
requested is readily available and utilized by manufacturers in other 
areas.
    Likely Respondents: Drug manufacturers and covered entities.
    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.

[[Page 35985]]



                                     Total Estimated Annualized Burden Hours
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                                                     Number of
            Form name                Number of     responses per       Total         Hours per     Total burden
                                    respondents     respondent       responses      respondent         hours
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                                Hospital Enrollment, Additions & Recertifications
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340B Program Registrations &                 131               1             131            2.00             262
 Certifications for Hospitals *.
Certifications to Enroll                     620               7           4,340            0.50           2,170
 Hospital Outpatient Facilities
 *..............................
Hospital Annual Recertifications           2,618              10          26,180            0.25           6,545
 *..............................
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                      Registrations and Recertifications for Entities Other Than Hospitals
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340B Registrations for Community             679               1             679            1.00             679
 Health Centers *...............
340B Registrations for STD/TB                864               1             864            1.00             864
 Clinics *......................
340B Registrations for Various               166               1             166            1.00             166
 Other Eligible Entity Types *..
Community Health Center Annual             1,277               7           8,939            0.25           2,235
 Recertifications *.............
STD & TB Annual Recertifications           4,033               1           4,033            0.25           1,008
 *..............................
Annual Recertification for                 4,472               1           4,472            0.25           1,118
 entities other than Hospitals,
 Community Health Centers, and
 STD/TB Clinics *...............
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                          Contracted Pharmacy Services Registration & Recertifications
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Contracted Pharmacy Services               3,446              11          37,906            1.00          37,906
 Registration...................
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                                          Other Information Collections
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Submission of Administrative              19,322               1          19,322            0.25           4,831
 Changes for any Covered Entity
 *..............................
Submission of Administrative                 350               1             350             .50             175
 Changes for any Manufacturer *.
Pharmaceutical Pricing Agreement             200               1             200            1.00             200
 and PPA Addendum...............
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    Total.......................          38,178  ..............          99,542  ..............          58,159
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* Minor revisions since last the OMB submission, but burden was not affected.

    HRSA specifically requests comments on (1) the necessity and 
utility of the proposed information collection for the proper 
performance of the agency's functions, (2) the accuracy of the 
estimated burden, (3) ways to enhance the quality, utility, and clarity 
of the information to be collected, and (4) the use of automated 
collection techniques or other forms of information technology to 
minimize the information collection burden.

Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2022-12776 Filed 6-13-22; 8:45 am]
BILLING CODE 4165-15-P