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, OMB Number 0915-0327-Revision, 38639-38642 [2019-16872]

Download as PDF Federal Register / Vol. 84, No. 152 / Wednesday, August 7, 2019 / Notices I. Background Section 506B(c) of the FD&C Act (21 U.S.C. 356b(c)) requires FDA to publish an annual report on the status of postmarketing studies that applicants have committed to, or are required to conduct, and for which annual status reports have been submitted. Under §§ 314.81(b)(2)(vii) and 601.70 (21 CFR 314.81(b)(2)(vii) and 601.70), applicants of approved drugs and licensed biologics are required to submit annually a report on the status of each clinical safety, clinical efficacy, clinical pharmacology, and nonclinical toxicology study or clinical trial either required by FDA (PMRs) or that they have committed to conduct (PMCs), either at the time of approval or after approval of their new drug application, abbreviated new drug application, or biologics license application. The status of PMCs concerning chemistry, manufacturing, and production controls and the status of other studies or clinical trials conducted on an applicant’s own initiative are not required to be reported under §§ 314.81(b)(2)(vii) and 601.70 and are not addressed in this report. Furthermore, section 505(o)(3)(E) of the FD&C Act (21 U.S.C. 355(o)(3)(E)) requires that applicants report periodically on the status of each required study or clinical trial and each study or clinical trial otherwise undertaken to investigate a safety issue. An applicant must report on the progress of the PMR/PMC on the anniversary of the drug product’s approval 1 until the PMR/PMC is completed or terminated and FDA determines that the PMR/PMC has been fulfilled or that the PMR/PMC is either no longer feasible or would no longer provide useful information. The report on the status of the studies and clinical trials that applicants have agreed to, or are required to, conduct is on the FDA’s ‘‘Postmarketing Requirements and Commitments: Reports’’ web page at https:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/PostmarketingPhaseIVCommitments/ ucm064436.htm. II. Fiscal Year 2018 Report With this notice, FDA is announcing the availability of the Agency’s annual report entitled ‘‘Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments.’’ Information in this report covers any PMR/PMC that was established, in writing, at the time of approval or after approval of an application or a supplement to an application and summarizes the status of PMRs/PMCs in fiscal year (FY) 2018 (i.e., as of September 30, 2018). Information summarized in the report reflects combined data from the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research and includes the following: (1) The number of applicants with open PMRs/ PMCs; (2) the number of open PMRs/ PMCs; (3) the timeliness of applicant submission of the annual status reports (ASRs); (4) FDA-verified status of open PMRs/PMCs reported in § 314.81(b)(2)(vii) or § 601.70 ASRs; (5) the status of closed PMRs/PMCs; and (6) the distribution of the status by fiscal year of establishment 2 (FY2012 to FY2018) for PMRs and PMCs open at the end of FY2018, or those closed within FY2018. Additional information about PMRs/PMCs is provided on FDA’s website at https://www.fda.gov/Drugs/ GuidanceComplianceRegulatory Information/Post-marketingPhaseIV Commitments/default.htm. Dated: August 1, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–16878 Filed 8–6–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration 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, OMB Number 0915–0327—Revision Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of jspears on DSK3GMQ082PROD with NOTICES SUMMARY: 1 An applicant must submit an annual status report on the progress of each open PMR/PMC within 60 days of the anniversary date of U.S. approval of the original application or on an alternate reporting date that was granted by FDA in writing. Some applicants have requested and been granted by FDA alternate annual reporting dates to facilitate harmonized reporting across multiple applications. VerDate Sep<11>2014 18:14 Aug 06, 2019 Jkt 247001 2 The establishment date is the date of the formal FDA communication to the applicant that included the final FDA-required (PMR) or -requested (PMC) postmarketing study or clinical trial. PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 38639 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. DATES: Comments on this ICR should be received no later than September 6, 2019. ADDRESSES: Submit your comments, including the ICR Title, to the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by fax to 202–395–5806. A 60-day notice was published in the Federal Register on May 9, 2019, vol. 84, No. 90; pp. 20373–75. There were four public comments received. Some comments addressed policy issues that are outside of the scope of this information collection request. HRSA responded to technical comments that pertain to the ICR and revised the draft instruments based on technical comments received. FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance requests submitted to OMB for review, email Lisa Wright-Solomon, the HRSA Information Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443– 1984. SUPPLEMENTARY INFORMATION: 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 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 E:\FR\FM\07AUN1.SGM 07AUN1 38640 Federal Register / Vol. 84, No. 152 / Wednesday, August 7, 2019 / Notices jspears on DSK3GMQ082PROD with NOTICES 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 address specific statutory mandates. 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 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 that HRSA has transitioned completely to online versus hardcopy instruments. In doing so, some of the instruments have been revised to increase program efficiency and integrity. Below are descriptions of each of the instruments and any resulting revisions captured in both the registration and pricing component of the 340B Office of Pharmacy Affairs Information System (OPAIS). Enrollment/Registration To enroll and certify the eligible federally funded grantees and other safety net health care providers, HRSA requires 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 VerDate Sep<11>2014 16:49 Aug 06, 2019 Jkt 247001 level or entity level authorizing officials and primary contacts. The purpose of this registration information is to determine eligibility for the 340B Program. To maintain accurate records, HRSA requests entities to submit modifications to any administrative information that they submitted when initially enrolling into the Program. 340B covered entities 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, entities must certify the accuracy of the information provided and continued maintenance of their eligibility and comply with statutory mandates of the Program. Registration and annual recertification information is entered into the 340B OPAIS by entities and verified by HRSA staff according to 340B Program requirements. In response to the comments received, HRSA has made technical revisions to the draft instruments and explains the revisions below. 1. 340B Program Registrations & Certifications for Hospitals (applies to all hospital types): With the launch of 340B OPAIS in September 2017, HRSA removed the requirement for a Government Official to attest to the hospital classification of a parent hospital. HRSA would like to require parent hospitals to attach documents supporting the hospital classification that they select during registration. This is a more accurate and efficient way to determine the eligibility of parent hospital registrations, without increasing the burden, since the Government Official attestation has been removed. In response to comments, HRSA notes that the 340B Program Hospital Registration Instructions lists examples of the types of documentation that supports the hospital’s classification. The instructions are located at https:// www.hrsa.gov/sites/default/files/hrsa/ opa/340b-hospital-registrationinstructions.pdf. 2. 340B Program Registrations for STD/TB Clinics: HRSA is requesting that any STD and TB entity provide its Notice of Funding Opportunity (NOFO) number at the time of registration. HRSA is also requesting that an entity describe the type of in-kind funding it receives, as well as the period of the funding. This will assist HRSA in accurately determining the eligibility of the covered entity registration. This requirement would impose minimal burden on the public, as the NOFO number correlates to the Federal Grant Number, which is already required during registration. PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 In response to comments submitted during the first public review of this ICR, HRSA continues to believe there will be no additional burden associated with providing what type of in-kind funding they receive as it is expected to be provided as part of an audit of a covered entity. The draft instruments explain that in-kind contributions may be in the form of real property, equipment, supplies and other expendable property, and goods and services directly benefiting and specifically identifiable to the project or program. 3. 340B Registrations for Ryan White Entities: HRSA is requesting that any Ryan White entity provide its NOFO number at the time of registration. HRSA is also requesting that an entity provide the period of assistance. This will assist HRSA in accurately determining the eligibility of the registration. This requirement would impose minimal burden on the public, as the NOFO number correlates to the Federal Grant Number, which is already required during registration. 4. Medicaid Billing: HRSA is making a minor change to clarify the question about Medicaid billing. In response to comments received, HRSA has made general technical and editorial revisions to this instrument. Accurate records are critical to the prevention of drug diversion to noneligible individuals as well as duplicate discounts in the 340B Program. To maintain accurate records, HRSA also requires that covered 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. HRSA expects that the burden imposed these processes is low for recertification and minimal for submitting change requests. Contract Pharmacy Self-Certification 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 the arrangements and certify that signed agreements are in place with those contract pharmacies. In response to comments, HRSA has made several technical corrections to this instrument. 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 E:\FR\FM\07AUN1.SGM 07AUN1 38641 Federal Register / Vol. 84, No. 152 / Wednesday, August 7, 2019 / Notices outpatient drugs to eligible entities must sign a PPA with the Secretary of HHS 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 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, 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: Average manufacturer price, 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. One commenter suggested that HRSA list FDA ‘‘ingredient names’’ in the 340B OPAIS to simplify the search process for covered entities. HRSA will consider this for future collections due to system changes that would need to occur to operationalize this suggestion. 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 .......................................... 248 665 2,481 1 8 10 248 5,320 24,810 2.00 0.50 0.25 496 2,660 6,202 Registrations and Recertifications for Entities Other Than Hospitals 340B Registrations for Community Health Centers * .......... 340B Registrations for STD/TB Clinics * ............................. 340B Registrations for Various Other Eligible Entity Types * .............................................................................. Community Health Center Annual Recertifications ............. STD & TB Annual Recertifications ...................................... Annual Recertification for entities other than Hospitals, Community Health Centers, and STD/TB Clinics ............ 360 535 3 1 1,080 535 1.00 1.00 1,080 535 392 1,277 4,033 1 7 1 392 8,939 4,033 1.00 0.25 0.25 392 1,008 1,008 4,472 1 4,472 0.25 1,118 Contracted Pharmacy Services Registration & Recertifications Contracted Pharmacy Services Registration ....................... 2,048 11 22,528 1.00 22,528 19,322 1 19,322 ** 0.25 4,831 350 200 1 1 350 200 0.50 1 175 200 600 4 2,400 0.50 1,200 36,983 ........................ 94,629 ........................ 43,433 jspears on DSK3GMQ082PROD with NOTICES Other Information Collections Submission of Administrative Changes for any Covered Entity ................................................................................. Submission of Administrative Changes for any Manufacturer .................................................................................. Pharmaceutical Pricing Agreement and PPA Addendum ... Manufacturer Data Required to Verify the 340B Ceiling Price ................................................................................. Total .............................................................................. * Revised since last OMB submission, but burden was not affected. ** Burden changed from .50 to .25 due to the 340B OPAIS improvement. VerDate Sep<11>2014 16:49 Aug 06, 2019 Jkt 247001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\07AUN1.SGM 07AUN1 38642 Federal Register / Vol. 84, No. 152 / Wednesday, August 7, 2019 / Notices During the first public review of the ICR, HRSA inadvertently omitted the burden estimate for the instrument pertaining to manufacturer data required to verify the 340B ceiling price. The estimate for that instrument has been included here and HRSA invites comments to be submitted to OMB for consideration during the review and approval period. Maria G. Button, Director, Division of the Executive Secretariat. [FR Doc. 2019–16872 Filed 8–6–19; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review Advisory Council: Notice of Charter Renewal In accordance with Title 41 of the U.S. Code of Federal Regulations, Section 102–3.65(a), notice is hereby given that the Charter for the Center for Scientific Review Advisory Council was renewed for an additional two-year period on March 31, 2019. It is determined that the Center for Scientific Review Advisory Council is in the public interest in connection with the performance of duties imposed on the National Institutes of Health by law, and that these duties can best be performed through the advice and counsel of this group. Inquiries may be directed to Claire Harris, Director, Office of Federal Advisory Committee Policy, Office of the Director, National Institutes of Health, 6701 Democracy Boulevard, Suite 1000, Bethesda, Maryland 20892 (Mail code 4875), Telephone (301) 496– 2123, or harriscl@mail.nih.gov. Dated: August 1, 2019. Ronald J. Livingston, Jr., Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–16825 Filed 8–6–19; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES jspears on DSK3GMQ082PROD with NOTICES Substance Abuse and Mental Health Services Administration Advisory Committee for Women’s Services (ACWS); Notice of Meeting Pursuant to Public Law 92–463, notice is hereby given of a meeting of the Substance Abuse and Mental Health Services Administration’s (SAMHSA) VerDate Sep<11>2014 16:49 Aug 06, 2019 Jkt 247001 Advisory Committee for Women’s Services (ACWS) on August 20, 2019. The meeting will include discussions on assessing SAMHSA’s current strategies, including the mental health and substance use needs of the women and girls population. Additionally, the ACWS will be speaking with the Assistant Secretary of Mental Health and Substance Use regarding priorities and directions around behavioral health services and access for women and children. The meeting is open to the public and will be held at SAMHSA, 5600 Fishers Lane, Rockville, MD 20857. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions should be forwarded to the contact person by August 13, 2019. Oral presentations from the public will be scheduled at the conclusion of the meeting. Individuals interested in making oral presentations are encouraged to notify the contact person on or before August 13, 2019. Five minutes will be allotted for each presentation. The meeting may be accessed via telephone or web meeting. To obtain the call-in number and access code, submit written or brief oral comments, or request special accommodations for persons with disabilities, please register on-line at http:// snacregister.samhsa.gov/ MeetingList.aspx, or communicate with SAMHSA’s Designated Federal Officer, Ms. Valerie Kolick. Substantive meeting information and a roster of ACWS members may be obtained either by accessing the SAMHSA Committees’ Web https:// www.samhsa.gov/about-us/advisorycouncils/meetings, or by contacting Ms. Kolick. Committee Name: Substance Abuse and Mental Health Services Administration, Advisory Committee for Women’s Services (ACWS). Date/Time/Type: Tuesday, August 20, 2019, from: 9:00 a.m. to 3:00 p.m. EDT (OPEN). Place: SAMHSA, 5600 Fishers Lane, Rockville, MD 20857. Contact: Valerie Kolick, Designated Federal Officer, SAMHSA’s Advisory Committee for Women’s Services, 5600 Fishers Lane, Rockville, MD 20857, Telephone: (240) 276–1738, Email: Valerie.kolick@samhsa.hhs.gov. PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 Dated: August 1, 2019. Carlos Castillo, CAPT, USPHS, Committee Management Officer, Substance Abuse and Mental Health, Services Administration. [FR Doc. 2019–16831 Filed 8–6–19; 8:45 am] BILLING CODE 4162–20–P DEPARTMENT OF THE INTERIOR Bureau of Land Management [LLORW00000.10200000. DF0000.LXSSH1080000.19X.HAG 19–0096] Notice of Public Meetings for the San Juan Islands National Monument Advisory Committee Bureau of Land Management, Interior. ACTION: Notice of public meeting. AGENCY: In accordance with the Federal Land Policy and Management Act and the Federal Advisory Committee Act of 1972, the U.S. Department of the Interior, Bureau of Land Management’s (BLM), San Juan Islands National Monument Advisory Committee (MAC) will meet as indicated below: DATES: The MAC will hold a public meeting on Tuesday, Sept. 24, 2019. This meeting will run from 10 a.m. to 3:30 p.m. The public comment period is scheduled for 2 p.m. ADDRESSES: The meeting will be held at the Lopez Community Center for the Arts, 204 Village Rd, Lopez Island, WA 98261. The public may send written comments to the MAC at BLM Spokane District, Attn. MAC, 1103 N Fancher, Spokane Valley, WA 99212. FOR FURTHER INFORMATION CONTACT: Jeff Clark, Spokane District Public Affairs Officer, 1103 N Fancher, Spokane Valley, WA 99212, (509) 536–1297, or jeffclark@blm.gov. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Relay Service at 1(800) 877–8339 to contact the above individual during normal business hours. This service is available 24 hours a day, 7 days a week, to leave a message or question with the above individual. You will receive a reply during normal business hours. SUPPLEMENTARY INFORMATION: The San Juan Islands MAC is comprised of 12 members representing a wide array of interests, including recreation, tribal interests, education, environmental organizations, and landowners. The MAC advises the Secretary of the Interior with respect to the preparation and implementation of the San Juan SUMMARY: E:\FR\FM\07AUN1.SGM 07AUN1

Agencies

[Federal Register Volume 84, Number 152 (Wednesday, August 7, 2019)]
[Notices]
[Pages 38639-38642]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16872]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


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, 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 the Paperwork Reduction Act of 1995, HRSA 
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.

DATES: Comments on this ICR should be received no later than September 
6, 2019.

ADDRESSES: Submit your comments, including the ICR Title, to the desk 
officer for HRSA, either by email to [email protected] or by 
fax to 202-395-5806.
    A 60-day notice was published in the Federal Register on May 9, 
2019, vol. 84, No. 90; pp. 20373-75. There were four public comments 
received. Some comments addressed policy issues that are outside of the 
scope of this information collection request. HRSA responded to 
technical comments that pertain to the ICR and revised the draft 
instruments based on technical comments received.

FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance 
requests submitted to OMB for review, email Lisa Wright-Solomon, the 
HRSA Information Collection Clearance Officer at [email protected] or 
call (301) 443-1984.

SUPPLEMENTARY INFORMATION:
    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 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

[[Page 38640]]

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 address specific statutory 
mandates. 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 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 that HRSA has transitioned completely to online 
versus hardcopy instruments. In doing so, some of the instruments have 
been revised to increase program efficiency and integrity. Below are 
descriptions of each of the instruments and any resulting revisions 
captured in both the registration and pricing component of the 340B 
Office of Pharmacy Affairs Information System (OPAIS).

Enrollment/Registration

    To enroll and certify the eligible federally funded grantees and 
other safety net health care providers, HRSA requires 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. The purpose of this registration information is to determine 
eligibility for the 340B Program. To maintain accurate records, HRSA 
requests entities to submit modifications to any administrative 
information that they submitted when initially enrolling into the 
Program. 340B covered entities 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, entities must 
certify the accuracy of the information provided and continued 
maintenance of their eligibility and comply with statutory mandates of 
the Program.
    Registration and annual recertification information is entered into 
the 340B OPAIS by entities and verified by HRSA staff according to 340B 
Program requirements. In response to the comments received, HRSA has 
made technical revisions to the draft instruments and explains the 
revisions below.
    1. 340B Program Registrations & Certifications for Hospitals 
(applies to all hospital types): With the launch of 340B OPAIS in 
September 2017, HRSA removed the requirement for a Government Official 
to attest to the hospital classification of a parent hospital. HRSA 
would like to require parent hospitals to attach documents supporting 
the hospital classification that they select during registration. This 
is a more accurate and efficient way to determine the eligibility of 
parent hospital registrations, without increasing the burden, since the 
Government Official attestation has been removed. In response to 
comments, HRSA notes that the 340B Program Hospital Registration 
Instructions lists examples of the types of documentation that supports 
the hospital's classification. The instructions are located at https://www.hrsa.gov/sites/default/files/hrsa/opa/340b-hospital-registration-instructions.pdf.
    2. 340B Program Registrations for STD/TB Clinics: HRSA is 
requesting that any STD and TB entity provide its Notice of Funding 
Opportunity (NOFO) number at the time of registration. HRSA is also 
requesting that an entity describe the type of in-kind funding it 
receives, as well as the period of the funding. This will assist HRSA 
in accurately determining the eligibility of the covered entity 
registration. This requirement would impose minimal burden on the 
public, as the NOFO number correlates to the Federal Grant Number, 
which is already required during registration.
    In response to comments submitted during the first public review of 
this ICR, HRSA continues to believe there will be no additional burden 
associated with providing what type of in-kind funding they receive as 
it is expected to be provided as part of an audit of a covered entity. 
The draft instruments explain that in-kind contributions may be in the 
form of real property, equipment, supplies and other expendable 
property, and goods and services directly benefiting and specifically 
identifiable to the project or program.
    3. 340B Registrations for Ryan White Entities: HRSA is requesting 
that any Ryan White entity provide its NOFO number at the time of 
registration. HRSA is also requesting that an entity provide the period 
of assistance. This will assist HRSA in accurately determining the 
eligibility of the registration. This requirement would impose minimal 
burden on the public, as the NOFO number correlates to the Federal 
Grant Number, which is already required during registration.
    4. Medicaid Billing: HRSA is making a minor change to clarify the 
question about Medicaid billing. In response to comments received, HRSA 
has made general technical and editorial revisions to this instrument.
    Accurate records are critical to the prevention of drug diversion 
to non-eligible individuals as well as duplicate discounts in the 340B 
Program. To maintain accurate records, HRSA also requires that covered 
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. HRSA expects that 
the burden imposed these processes is low for recertification and 
minimal for submitting change requests.

Contract Pharmacy Self-Certification

    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 the arrangements and certify that signed agreements 
are in place with those contract pharmacies. In response to comments, 
HRSA has made several technical corrections to this instrument.

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

[[Page 38641]]

outpatient drugs to eligible entities must sign a PPA with the 
Secretary of HHS 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

    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, 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: Average manufacturer price, 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. One commenter suggested that HRSA list 
FDA ``ingredient names'' in the 340B OPAIS to simplify the search 
process for covered entities. HRSA will consider this for future 
collections due to system changes that would need to occur to 
operationalize this suggestion.
    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 &                 248               1             248            2.00             496
 Certifications for Hospitals *.
Certifications to Enroll                     665               8           5,320            0.50           2,660
 Hospital Outpatient Facilities.
Hospital Annual Recertifications           2,481              10          24,810            0.25           6,202
----------------------------------------------------------------------------------------------------------------
                      Registrations and Recertifications for Entities Other Than Hospitals
----------------------------------------------------------------------------------------------------------------
340B Registrations for Community             360               3           1,080            1.00           1,080
 Health Centers *...............
340B Registrations for STD/TB                535               1             535            1.00             535
 Clinics *......................
340B Registrations for Various               392               1             392            1.00             392
 Other Eligible Entity Types *..
Community Health Center Annual             1,277               7           8,939            0.25           1,008
 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.................
----------------------------------------------------------------------------------------------------------------
                          Contracted Pharmacy Services Registration & Recertifications
----------------------------------------------------------------------------------------------------------------
Contracted Pharmacy Services               2,048              11          22,528            1.00          22,528
 Registration...................
----------------------------------------------------------------------------------------------------------------
                                          Other Information Collections
----------------------------------------------------------------------------------------------------------------
Submission of Administrative              19,322               1          19,322         ** 0.25           4,831
 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             200
 and PPA Addendum...............
Manufacturer Data Required to                600               4           2,400            0.50           1,200
 Verify the 340B Ceiling Price..
                                 -------------------------------------------------------------------------------
    Total.......................          36,983  ..............          94,629  ..............          43,433
----------------------------------------------------------------------------------------------------------------
* Revised since last OMB submission, but burden was not affected.
** Burden changed from .50 to .25 due to the 340B OPAIS improvement.


[[Page 38642]]

    During the first public review of the ICR, HRSA inadvertently 
omitted the burden estimate for the instrument pertaining to 
manufacturer data required to verify the 340B ceiling price. The 
estimate for that instrument has been included here and HRSA invites 
comments to be submitted to OMB for consideration during the review and 
approval period.

Maria G. Button,
Director, Division of the Executive Secretariat.
[FR Doc. 2019-16872 Filed 8-6-19; 8:45 am]
BILLING CODE 4165-15-P