Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Enrollment and Re-Certification of Covered Entities in the 340B Drug Pricing Program, OMB Number 0915-0327-Revision., 65212-65215 [2022-23518]
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collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
No.
Title of collection
Infant Formula Requirements ..................................................................................................................................
Export of Medical Devices; Foreign Letters of Approval .........................................................................................
Center for Devices and Radiological Health Appeals Processes ...........................................................................
Review Transparency & Communication for New Molecular Entity NDAs & Original BLAs ..................................
Dated: October 24, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–23510 Filed 10–27–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Enrollment and ReCertification of Covered Entities in the
340B Drug Pricing Program, OMB
Number 0915–0327—Revision.
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In compliance with of the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30-day
comment period for this notice has
closed.
SUMMARY:
Comments on this ICR should be
received no later than November 28,
2022.
DATES:
Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under Review—Open for
Public Comments’’ or by using the
search function.
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ADDRESSES:
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To
request a copy of the clearance requests
submitted to OMB for review, email
Samantha Miller, the Acting HRSA
Information Collection Clearance
Officer, at paperwork@hrsa.gov or call
(301) 443–9094.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Enrollment and Re-Certification of
Covered 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. A 60-day notice was
FOR FURTHER INFORMATION CONTACT:
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0910–0256
0910–0264
0910–0738
0910–0746
Date
approval
expires
3/31/2023
10/31/2025
10/31/2025
10/31/2025
published in the Federal Register on
June 14, 2022, vol. 87, No. 114; pp.
35983–85. There were five comments.
Some comments addressed policy issues
that are outside the scope of this
information collection request. HRSA
responded to technical comments that
pertained to the ICR and revised the
draft instruments based on the
comments received.
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 several forms have been revised
to increase program efficiency and
integrity. Below are descriptions of each
of the forms and revisions that are
captured in both the registration and
pricing component of the 340B Office of
Pharmacy Affairs Information System
(OPAIS).
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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 covered entity level authorizing
officials and primary contacts. To
maintain accurate records, HRSA
requests covered entities submit
modifications to any administrative
information that they submitted when
initially enrolling into the 340B
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
340B 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. In response to
the comments received, HRSA has made
technical and other revisions to the draft
instruments and discusses the revisions
below.
1. 340B Program Registrations &
Recertifications for Hospitals (applies to
all hospital types): In September 2017,
HRSA launched 340B OPAIS, which
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. During the
first public review of this ICR,
commenters agreed with removing the
Government Official contact
information for a parent hospital.
2. 340B Registrations &
Recertifications for Ryan White Covered
Entities: Previously, HRSA requested
that Ryan White covered entities
provide a 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
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component to determine the eligibility
of a Ryan White covered entity’s
registration. Since the NOFO number
correlates to the Ryan White covered
entity’s Federal Grant Number, which is
already required to be entered in 340B
OPAIS during registration, the NOFO
number is not needed. During the first
public review of this ICR, commenters
agreed with removing the requirement
for Ryan White covered entities to
provide a NOFO number at the time of
registration and recertification.
3. 340B Registration, Recertification &
Change Requests for Shipping Address:
In the 60-day notice (87 FR 35,983, June
14, 2022), HRSA proposed to include
clarifying information for covered
entities to complete the shipping
address section in 340B OPAIS. This
information was added to assist covered
entities in determining the exact
shipping address location and
relationship to the covered entity. In
response to comments submitted during
the first public review of this ICR, HRSA
is removing this section from the
instrument and will plan to release
guidance on shipping address locations
in the future.
4. 340B Program Registrations,
Recertifications & Change Requests for
Hospitals (applies to rural referral
centers and sole community hospital
covered entity types): HRSA proposed
to revise the 340B OPAIS registration for
the rural referral centers and sole
community hospital covered entity
types. 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 covered entities.
5. 340B Program Registrations and
Recertification for Authorizing Official
Certification/Attestation: In the 60-day
notice (87 FR 35,983, June 14, 2022),
HRSA proposed to make revisions to the
Authorizing Official certification by
removing the requirement that any
contract pharmacy arrangement is
performed in accordance with OPA
requirements and guidelines. Several
commenters questioned why HRSA was
removing this statement from the
Authorizing Official’s certification of a
covered entity’s registration or
recertification in the 340B Program.
HRSA removed this information as it
was duplicative with information found
on other instruments (e.g., the contract
pharmacy registration form) and already
existed on the registration and
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recertification documentation. HRSA
believes that this revision will reduce
burden on covered entities.
6. 340B Program Change Requests for
Hospitals: HRSA proposed inclusion of
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 covered
entities, as this is an option to change
the information by the hospital.
7. 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.
8. 340B Program Recertifications &
Change Requests for Hospitals: HRSA
proposed clarifying when a 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. In response to comments
received, HRSA has made general
technical and editorial revisions to this
instrument.
9. Medicaid Billing Information: In
the 60-day notice (87 FR 35,983, June
14, 2022), HRSA proposed to make a
minor clarification regarding whether a
340B drug to an outpatient at a
pharmacy or as part of a medical
encounter. In response to comments
submitted during the first public review
of this ICR and after further
consideration, HRSA is removing this
section from the instrument and will
plan to release future guidance on this
issue.
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.
Pharmaceutical Pricing Agreement and
Addendum
Section 340B(a)(1) of the PHS Act
provides that a manufacturer who sells
covered outpatient drugs to eligible
covered entities must sign a
Pharmaceutical Pricing Agreement (the
‘‘Agreement’’) with the Secretary in
which the manufacturer agrees to charge
a price for covered outpatient drugs that
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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 requirements, which
have been incorporated in 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), Food
and Drug Administration 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.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Total
responses
Hours per
respondent
Total burden
hours
Hospital Enrollment, Additions & Recertifications
340B Program Registrations & Certifications for Hospitals *
Certifications to Enroll Hospital Outpatient Facilities * .........
Hospital Annual Recertifications * ........................................
131
620
2618
1
7
10
131
4340
26180
2.00
0.50
0.25
262
2170
6545
Registrations and Recertifications for Covered Entities Other Than Hospitals
340B Registrations for Community Health Centers * ..........
340B Registrations for STD/TB Clinics * .............................
340B Registrations for Various Other Eligible Covered Entity Types * ........................................................................
Community Health Center Annual Recertifications * ...........
STD & TB Annual Recertifications * ....................................
Annual Recertification for covered entities other than Hospitals, Community Health Centers, and STD/TB Clinics *
679
864
1
1
679
864
1.00
1.00
679
864
166
1277
4033
1
7
1
166
8939
4033
1.00
0.25
0.25
166
2235
1008
4472
1
4472
0.25
1118
Contracted Pharmacy Services Registration & Recertifications
Contracted Pharmacy Services Registration .......................
3446
11
37906
1.00
37906
19322
1
19322
0.25
4831
350
200
1
1
350
200
0.50
1.00
175
200
38,178
........................
99,542
........................
58,159
Other Information Collections
Submission of Administrative Changes for any Covered
Entity * ...............................................................................
Submission of Administrative Changes for any Manufacturer * ................................................................................
Pharmaceutical Pricing Agreement and PPA Addendum ...
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Total ..............................................................................
* 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
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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
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use of automated collection techniques
or other forms of information
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technology to minimize the information
collection burden.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Maria G. Button,
Director, Executive Secretariat.
National Institutes of Health
[FR Doc. 2022–23518 Filed 10–27–22; 8:45 am]
National Institute of Environmental
Health Sciences; Notice of Meeting
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases Amended Notice
of Meeting
Notice is hereby given of a change in
the meeting of the National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel, which was published
in the Federal Register on October 11,
2022, FR Doc 2022–22017, 87 FR 61342.
Amendment to change panel name
from NIAID Clinical Trial Planning
Grant (R34 Clinical Trial Not Allowed)
to NIAID Clinical Trial Planning Grant
(R34 Clinical Trial Not Allowed) and
Implementation Cooperative Agreement
(U01 Clinical Trial Required). The
meeting is closed to the public.
Dated: October 25, 2022.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–23541 Filed 10–27–22; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
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National Institute of Allergy and
Infectious Diseases; Amended Notice
of Closed Meeting
Notice is hereby given of a change in
the meeting of the National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel NIAID Investigator
Initiated Program Project Applications
(P01 Clinical Trial Not Allowed) which
was published in the Federal Register
on September 30, 2022, FR Doc 2022–
21261, 87 FR 59446.
Amendment to change meeting date
from October 26, 2022, to November 14,
2022. The meeting is closed to the
public.
Dated: October 25, 2022.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–23540 Filed 10–27–22; 8:45 am]
BILLING CODE 4140–01–P
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Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Board of Scientific
Counselors, NIEHS.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend as well
as those who need special assistance,
such as sign language interpretation or
other reasonable accommodations,
should notify the Contact Person listed
below in advance of the meeting. The
open session will be videocast and can
be accessed from the NIH Videocasting
website (https://videocast.nih.gov/).
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended
for the consideration of personnel
qualifications and performance, and the
competence of individual investigators,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Board of Scientific
Counselors, NIEHS.
Date: December 4, 2022.
Closed: 7:00 p.m. to 8:30 p.m.
Agenda: Discussion of BSC Reviews.
Place: National Institute of Environmental
Health Science, 111 T. W. Alexander Drive,
Research Triangle Park, NC 27709 (Hybrid
Meeting).
Open: December 5, 2022, 9:00 a.m. to 12:05
p.m.
Agenda: Meeting Overview and Q & A
Sessions (Calcium Signaling in Health &
Disease Group, Inositol Signaling Group, and
Molecular Endocrinology Group).
Place: National Institute of Environmental
Health Science, 111 T. W. Alexander Drive,
Research Triangle Park, NC 27709 (Hybrid
Meeting).
Closed: December 5, 2022, 12:05 p.m. to
1:05 p.m.
Agenda: To review and evaluate personnel
qualifications and performance, and
competence of individual investigators.
Place: National Institute of Environmental
Health Science, 111 T. W. Alexander Drive,
Research Triangle Park, NC 27709 (Hybrid
Meeting).
Open: December 5, 2022, 1:05 p.m. to 2:45
p.m.
Agenda: Q & A Sessions (Nucleolar
Integrity Group and Metabolism, Genes and
Environment Group).
Place: National Institute of Environmental
Health Science, 111 T. W. Alexander Drive,
Research Triangle Park, NC 27709 (Hybrid
Meeting).
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65215
Closed: December 5, 2022, 3:00 p.m. to
4:00 p.m.
Agenda: To review and evaluate personnel
qualifications and performance, and
competence of individual investigators.
Place: National Institute of Environmental
Health Science, 111 T. W. Alexander Drive,
Research Triangle Park, NC 27709 (Hybrid
Meeting).
Open: December 5, 2022, 4:00 p.m. to 4:50
p.m.
Agenda: Q & A Sessions (In Vivo
Neurobiology Group and Neurobiology
Group).
Place: National Institute of Environmental
Health Science, 111 T. W. Alexander Drive,
Research Triangle Park, NC 27709 (Hybrid
Meeting).
Closed: December 5, 2022, 4:50 p.m. to
5:05 p.m.
Agenda: To review and evaluate personnel
qualifications and performance, and
competence of individual investigators.
Place: National Institute of Environmental
Health Science, 111 T. W. Alexander Drive,
Research Triangle Park, NC 27709 (Hybrid
Meeting).
Open: December 6, 2022, 8:45 a.m. to 9:35
a.m.
Agenda: Q & A Session (Mechanism of
Mutation Group and Genome Integrity &
Structural Biology Group).
Place: National Institute of Environmental
Health Science, 111 T. W. Alexander Drive,
Research Triangle Park, NC 27709 (Hybrid
Meeting).
Closed: December 6, 2022, 9:50 a.m. to
10:05 a.m.
Agenda: To review and evaluate personnel
qualifications and performance, and
competence of individual investigators.
Place: National Institute of Environmental
Health Science, 111 T. W. Alexander Drive,
Research Triangle Park, NC 27709 (Hybrid
Meeting).
Open: December 6, 2022, 10:05 a.m. to
12:00 p.m.
Agenda: Poster Session.
Place: National Institute of Environmental
Health Science, 111 T. W. Alexander Drive,
Research Triangle Park, NC 27709 (Hybrid
Meeting).
Closed: December 6, 2022, 1:00 p.m. to
5:30 p.m.
Agenda: Session with Fellows and Staff
Scientists; Review of Flow Cytometry Center
Molecular Genomics Core Laboratory and
Fluorescence Microscopy and Imaging
Center; BSC Discussion & completion of
Individual Review Assignments; Debriefing
to NIEHS/DIR Leadership.
Place: National Institute of Environmental
Health Science, 111 T. W. Alexander Drive,
Research Triangle Park, NC 27709 (Hybrid
Meeting).
Contact Person: Darryl C. Zeldin, Scientific
Director & Principal Investigator, Division of
Intramural Research, National Institute of
Environmental Sciences, NIH, 111 T. W.
Alexander Drive, Mail drop MSC A2–09,
Research Triangle Park, NC 27709, 919–541–
1169, zeldin@niehs.nih.gov.
Any interested person may file written
comments with the committee by forwarding
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]]>Agencies
[Federal Register Volume 87, Number 208 (Friday, October 28, 2022)]
[Notices]
[Pages 65212-65215]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23518]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment Request; Enrollment and Re-
Certification of Covered Entities in the 340B Drug Pricing Program, OMB
Number 0915-0327--Revision.
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with of the Paperwork Reduction Act of 1995,
HRSA has submitted an Information Collection Request (ICR) to the
Office of Management and Budget (OMB) for review and approval. Comments
submitted during the first public review of this ICR will be provided
to OMB. OMB will accept further comments from the public during the
review and approval period. OMB may act on HRSA's ICR only after the
30-day comment period for this notice has closed.
DATES: Comments on this ICR should be received no later than November
28, 2022.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under Review--Open for
Public Comments'' or by using the search function.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email Samantha Miller, the Acting
HRSA Information Collection Clearance Officer, at [email protected] or
call (301) 443-9094.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: Enrollment and Re-
Certification of Covered 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. A 60-day
notice was published in the Federal Register on June 14, 2022, vol. 87,
No. 114; pp. 35983-85. There were five comments. Some comments
addressed policy issues that are outside the scope of this information
collection request. HRSA responded to technical comments that pertained
to the ICR and revised the draft instruments based on the comments
received.
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 several forms have been revised to increase program
efficiency and integrity. Below are descriptions of each of the forms
and revisions that are captured in both the registration and pricing
component of the 340B Office of Pharmacy Affairs Information System
(OPAIS).
[[Page 65213]]
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 covered entity level authorizing officials and primary
contacts. To maintain accurate records, HRSA requests covered entities
submit modifications to any administrative information that they
submitted when initially enrolling into the 340B 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 340B 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. In response to the comments received,
HRSA has made technical and other revisions to the draft instruments
and discusses the revisions below.
1. 340B Program Registrations & Recertifications for Hospitals
(applies to all hospital types): In September 2017, HRSA launched 340B
OPAIS, which 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. During the first public review of
this ICR, commenters agreed with removing the Government Official
contact information for a parent hospital.
2. 340B Registrations & Recertifications for Ryan White Covered
Entities: Previously, HRSA requested that Ryan White covered entities
provide a 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 covered entity's
registration. Since the NOFO number correlates to the Ryan White
covered entity's Federal Grant Number, which is already required to be
entered in 340B OPAIS during registration, the NOFO number is not
needed. During the first public review of this ICR, commenters agreed
with removing the requirement for Ryan White covered entities to
provide a NOFO number at the time of registration and recertification.
3. 340B Registration, Recertification & Change Requests for
Shipping Address: In the 60-day notice (87 FR 35,983, June 14, 2022),
HRSA proposed to include clarifying information for covered entities to
complete the shipping address section in 340B OPAIS. This information
was added to assist covered entities in determining the exact shipping
address location and relationship to the covered entity. In response to
comments submitted during the first public review of this ICR, HRSA is
removing this section from the instrument and will plan to release
guidance on shipping address locations in the future.
4. 340B Program Registrations, Recertifications & Change Requests
for Hospitals (applies to rural referral centers and sole community
hospital covered entity types): HRSA proposed to revise the 340B OPAIS
registration for the rural referral centers and sole community hospital
covered entity types. 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 covered
entities.
5. 340B Program Registrations and Recertification for Authorizing
Official Certification/Attestation: In the 60-day notice (87 FR 35,983,
June 14, 2022), HRSA proposed to make revisions to the Authorizing
Official certification by removing the requirement that any contract
pharmacy arrangement is performed in accordance with OPA requirements
and guidelines. Several commenters questioned why HRSA was removing
this statement from the Authorizing Official's certification of a
covered entity's registration or recertification in the 340B Program.
HRSA removed this information as it was duplicative with information
found on other instruments (e.g., the contract pharmacy registration
form) and already existed on the registration and recertification
documentation. HRSA believes that this revision will reduce burden on
covered entities.
6. 340B Program Change Requests for Hospitals: HRSA proposed
inclusion of 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 covered entities, as this is an
option to change the information by the hospital.
7. 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.
8. 340B Program Recertifications & Change Requests for Hospitals:
HRSA proposed clarifying when a 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.
In response to comments received, HRSA has made general technical and
editorial revisions to this instrument.
9. Medicaid Billing Information: In the 60-day notice (87 FR
35,983, June 14, 2022), HRSA proposed to make a minor clarification
regarding whether a 340B drug to an outpatient at a pharmacy or as part
of a medical encounter. In response to comments submitted during the
first public review of this ICR and after further consideration, HRSA
is removing this section from the instrument and will plan to release
future guidance on this issue.
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.
Pharmaceutical Pricing Agreement and Addendum
Section 340B(a)(1) of the PHS Act provides that a manufacturer who
sells covered outpatient drugs to eligible covered entities must sign a
Pharmaceutical Pricing Agreement (the ``Agreement'') with the Secretary
in which the manufacturer agrees to charge a price for covered
outpatient drugs that
[[Page 65214]]
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 requirements, which have been incorporated in 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), Food and Drug Administration 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.
Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
Number of
Form name Number of responses per Total Hours per Total burden
respondents respondent responses respondent hours
----------------------------------------------------------------------------------------------------------------
Hospital Enrollment, Additions & Recertifications
----------------------------------------------------------------------------------------------------------------
340B Program Registrations & 131 1 131 2.00 262
Certifications for Hospitals *.
Certifications to Enroll 620 7 4340 0.50 2170
Hospital Outpatient Facilities
*..............................
Hospital Annual Recertifications 2618 10 26180 0.25 6545
*..............................
----------------------------------------------------------------------------------------------------------------
Registrations and Recertifications for Covered Entities Other Than Hospitals
----------------------------------------------------------------------------------------------------------------
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 Covered Entity
Types *........................
Community Health Center Annual 1277 7 8939 0.25 2235
Recertifications *.............
STD & TB Annual Recertifications 4033 1 4033 0.25 1008
*..............................
Annual Recertification for 4472 1 4472 0.25 1118
covered entities other than
Hospitals, Community Health
Centers, and STD/TB Clinics *..
----------------------------------------------------------------------------------------------------------------
Contracted Pharmacy Services Registration & Recertifications
----------------------------------------------------------------------------------------------------------------
Contracted Pharmacy Services 3446 11 37906 1.00 37906
Registration...................
----------------------------------------------------------------------------------------------------------------
Other Information Collections
----------------------------------------------------------------------------------------------------------------
Submission of Administrative 19322 1 19322 0.25 4831
Changes for any Covered Entity
*..............................
Submission of Administrative 350 1 350 0.50 175
Changes for any Manufacturer *.
Pharmaceutical Pricing Agreement 200 1 200 1.00 200
and PPA Addendum...............
-------------------------------------------------------------------------------
Total....................... 38,178 .............. 99,542 .............. 58,159
----------------------------------------------------------------------------------------------------------------
* 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
[[Page 65215]]
technology to minimize the information collection burden.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2022-23518 Filed 10-27-22; 8:45 am]
BILLING CODE 4165-15-P
