Federal Register / Vol. 87, No. 114 / Tuesday, June 14, 2022 / Notices 35983 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) 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. Consideration will be given 

to comments and suggestions submitted 

within 60 days of this publication. 

Authority: Section 5(a) of the ‘‘Torture 

Victims Relief Act of 1998,’’ Public Law 

105–320 (22 U.S.C. 2152 note) 

Assistance for Treatment of Torture 

Victims. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2022–12816 Filed 6–13–22; 8:45 am] 

BILLING CODE 4184–46–P 

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. 

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 

paperwork@hrsa.gov 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 paperwork@hrsa.gov 

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 


lotter on DSK11XQN23PROD with NOTICES1
35984 Federal Register / Vol. 87, No. 114 / Tuesday, June 14, 2022 / Notices 

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. 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 87, No. 114 / Tuesday, June 14, 2022 / Notices 35985 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Hours per 

respondent 

Total 

burden hours 

Hospital Enrollment, Additions & Recertifications 

340B Program Registrations & Certifications for Hospitals * 131 1 131 2.00 262 

Certifications to Enroll Hospital Outpatient Facilities * ......... 620 7 4,340 0.50 2,170 

Hospital Annual Recertifications * ........................................ 2,618 10 26,180 0.25 6,545 

Registrations and Recertifications for Entities Other Than Hospitals 

340B Registrations for Community Health Centers * .......... 679 1 679 1.00 679 

340B Registrations for STD/TB Clinics * ............................. 864 1 864 1.00 864 

340B Registrations for Various Other Eligible Entity 

Types * .............................................................................. 166 1 166 1.00 166 

Community Health Center Annual Recertifications * ........... 1,277 7 8,939 0.25 2,235 

STD & TB Annual Recertifications * .................................... 4,033 1 4,033 0.25 1,008 

Annual Recertification for entities other than Hospitals, 

Community Health Centers, and STD/TB Clinics * .......... 4,472 1 4,472 0.25 1,118 

Contracted Pharmacy Services Registration & Recertifications 

Contracted Pharmacy Services Registration ....................... 3,446 11 37,906 1.00 37,906 

Other Information Collections 

Submission of Administrative Changes for any Covered 

Entity * ............................................................................... 19,322 1 19,322 0.25 4,831 

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

Pharmaceutical Pricing Agreement and PPA Addendum ... 200 1 200 1.00 200 

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 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Child Health and Human Development Initial 

Review Group; Biobehavioral and Behavioral 

Sciences Study Section. 

Date: July 22, 2022. 

Time: 10:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development, National Institutes of Health, 

6710B Rockledge Drive, Room 2131B, 

Bethesda, MD 20892 (Video Assisted 

Meeting). 

Contact Person: Luis E. Dettin, Ph.D., M.S., 

M.A., Scientific Review Officer, Scientific 

Review Branch, Eunice Kennedy Shriver 

National Institute of Child Health and 

Human Development, National Institutes of 

Health, 6710B Rockledge Drive, Room 2131B, 

Bethesda, MD 20892, (301) 219–3044, 

luis.dettin@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.865, Research for Mothers 

and Children, National Institutes of Health, 

HHS) 

Dated: June 8, 2022. 

David W. Freeman, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–12800 Filed 6–13–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the Center for Scientific 

Review Special Emphasis Panel, Small 

Business: Health Informatics, June 29, 

2022, 10:00 a.m. to June 29, 2022, 7:00 

p.m., National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD, 20892 

which was published in the Federal 

Register on June 03, 2022, FR Doc 2022– 

11873, 87 FR 33799. 

This notice is being amended to 

change the meeting date from June 29, 

2022, to June 29, 2022—June 30, 2022. 

The meeting is closed to the public. 


lotter on DSK11XQN23PROD with NOTICES1