Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: COVID-19 Provider Relief Programs Application and Attestation Portal, and Claims Reimbursement Submission Activities, 47119-47120 [2021-18018]

Download as PDF Federal Register / Vol. 86, No. 160 / Monday, August 23, 2021 / Notices Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product. To obtain approval, the ANDA applicant must show, among other things, that the generic drug product: (1) Has the same active ingredient(s), dosage form, route of administration, strength, conditions of use, and, with certain exceptions, labeling as the listed drug, which is a version of the drug that was previously approved and (2) is bioequivalent to the listed drug. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). Section 505(j)(7) of the FD&C Act requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the ‘‘Approved Drug Products with Therapeutic Equivalence Evaluations,’’ which is known generally as the ‘‘Orange Book.’’ Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug’s NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug. ORTHO-CEPT (desogestrel-ethinyl estradiol) 21- and 28-day oral tablets, 0.15 mg/0.03 mg, is the subject of NDA 020301, held by Janssen Pharmaceuticals, Inc., and initially approved on December 14, 1992. ORTHO-CEPT is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. In a letter dated October 7, 2014, Janssen Pharmaceuticals, Inc., notified FDA that ORTHO-CEPT (desogestrelethinyl estradiol) 21- and 28-day oral tablets, 0.15 mg/0.03 mg, were being discontinued, and FDA moved the drug product to the ‘‘Discontinued Drug Product List’’ section of the Orange Book. Arnall Golden Gregory LLP submitted a citizen petition dated March 11, 2021 (Docket No. FDA–2021–P–0292), under jbell on DSKJLSW7X2PROD with NOTICES SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 18:11 Aug 20, 2021 Jkt 253001 21 CFR 10.30, requesting that the Agency determine whether ORTHOCEPT (desogestrel-ethinyl estradiol) oral tablets, were withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that ORTHO-CEPT (desogestrel-ethinyl estradiol) 21- and 28-day oral tablets, 0.15 mg/0.03 mg, were not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that ORTHOCEPT (desogestrel-ethinyl estradiol) 21and 28-day oral tablets, 0.15 mg/0.03 mg, were withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of ORTHOCEPT (desogestrel-ethinyl estradiol) 21and 28-day oral tablets, 0.15 mg/0.03 mg, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that this drug product was withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list ORTHO-CEPT (desogestrel-ethinyl estradiol) 21- and 28-day oral tablets, 0.15 mg/0.03 mg, in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. FDA will not begin procedures to withdraw approval of approved ANDAs that refer to this drug product. Additional ANDAs for this drug product may also be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: August 17, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–17990 Filed 8–20–21; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 47119 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration [OMB No. 0906–XXXX] Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: COVID–19 Provider Relief Programs Application and Attestation Portal, and Claims Reimbursement Submission Activities Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: 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 October 22, 2021. ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail 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 Lisa Wright-Solomon, the HRSA Information Collection Clearance Officer at (301) 443–1984. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the information request collection title for reference. Information Collection Request Title: COVID–19 Provider Relief Programs Application and Attestation Portal, and Claims Reimbursement Submission Activities, OMB No. 0906–XXXX. Abstract: HRSA administers the Provider Relief Programs (which includes the Provider Relief Fund (PRF), the American Rescue Plan Act Rural (ARPA–R) payments, the COVID–19 Coverage Assistance Fund (CAF), and the COVID–19 Claims Reimbursement to Health Care Providers and Facilities for Testing, Treatment, and Vaccine Administration for the Uninsured (Uninsured Program or UIP). The SUMMARY: E:\FR\FM\23AUN1.SGM 23AUN1 47120 Federal Register / Vol. 86, No. 160 / Monday, August 23, 2021 / Notices Provider Relief Programs disbursed, and are continuing to disburse, funds to eligible healthcare providers through two pathways: (1) Direct provider payments via the PRF and ARPA–R payments, and (2) claims reimbursement via the CAF and the UIP. This information collection includes four components: (1) The PRF and ARPA–R application portal; (2) the PRF and ARPA–R attestation portal; (3) the CAF application portal; and (4) the UIP application portal. To date, information for these programs has been collected under a Paperwork Reduction Act waiver executed pursuant to public health emergency authorities. HRSA is seeking comments regarding the CAF and the UIP for the first time. These information collections support administration of the Provider Relief Programs including the PRF, the Uninsured Program, and the CAF (funds for these three programs were appropriated under the Coronavirus Aid, Relief, and Economic Security Act (Pub. L. 116–136), Paycheck Protection Program and Health Care Enhancement Act (Pub. L. 116–139), Coronavirus Response and Relief Supplemental Appropriations Act (Division M of Pub. L. 116–260)), and the ARPA–R payments (funds were appropriated under the American Rescue Plan Act of 2021, Pub. L. 117–2). Need and Proposed Use of the Information: Providers who apply for Provider Relief Programs (i.e., PRF, ARPA–R, CAF, and UIP payments) must apply for direct provider payments or claims reimbursement and attest to a set of Terms and Conditions to enable HRSA’s appropriate disbursement and oversight of recipients’ use of funds. Information collected will allow for (1) assessing if recipients have met statutory and programmatic requirements; (2) conducting audits; (3) gathering data required to calculate, disburse, and report on PRF, ARPA–R, CAF, and UIP payments; and (4) program evaluation. HRSA staff may also use information collected to identify and report on trends in the effect of the COVID–19 pandemic on health care providers and uninsured or underinsured patients throughout the United States. HHS makes publicly available the names of payment recipients and the aggregate amounts received, for all providers who attest to receipt of a payment and acceptance of the Terms and Conditions or who retain payments for more than 90 days and are deemed Number of respondents Form name Average burden per response (in hours) Total responses Total burden hours Attestation Portal .................................................................. Application Portal ................................................................. CAF Application ................................................................... UIP Application .................................................................... 130,000 130,000 15,000 280,000 1 1 1 1 130,000 130,000 15,000 280,000 0.25 1.00 1.00 5.60 32,500 130,000 15,000 1,568,000 Total .............................................................................. 555,000 ........................ 555,000 ........................ 1,745,500 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. 2021–18018 Filed 8–20–21; 8:45 am] jbell on DSKJLSW7X2PROD with NOTICES Number of responses per respondent to have accepted the Terms and Conditions. By accepting funds, the recipient consents to HHS publicly disclosing the payments that recipient has received. Likely Respondents: Health care providers that apply to receive, or have applied to receive, PRF, ARPA–R, CAF, or UIP payments, and attested to the associated Terms and Conditions. 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: BILLING CODE 4165–15–P VerDate Sep<11>2014 18:11 Aug 20, 2021 Jkt 253001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Information Technology Advisory Committee 2021 Schedule of Meetings Office of the National Coordinator for Health Information Technology (ONC), HHS. AGENCY: ACTION: Notice of meetings. The Health Information Technology Advisory Committee (HITAC) was established in accordance with the 21st Century Cures Act and the Federal Advisory Committee Act. The HITAC, among other things, identifies priorities for standards adoption and makes recommendations to the National Coordinator for Health Information Technology (National Coordinator). The HITAC will hold public meetings SUMMARY: PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 throughout 2021. See list of public meetings below. FOR FURTHER INFORMATION CONTACT: Michael Berry, Designated Federal Officer, at Michael.Berry@hhs.gov, (202) 701–0795. Section 4003(e) of the 21st Century Cures Act (Pub. L. 114–255) establishes the Health Information Technology Advisory Committee (referred to as the ‘‘HITAC’’). The HITAC will be governed by the provisions of the Federal Advisory Committee Act (FACA) (Pub. L. 92– 463), as amended, (5 U.S.C. App.), which sets forth standards for the formation and use of federal advisory committees. SUPPLEMENTARY INFORMATION: Composition The HITAC is comprised of at least 25 members, of which: E:\FR\FM\23AUN1.SGM 23AUN1

Agencies

[Federal Register Volume 86, Number 160 (Monday, August 23, 2021)]
[Notices]
[Pages 47119-47120]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-18018]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration

[OMB No. 0906-XXXX]


Agency Information Collection Activities: Proposed Collection: 
Public Comment Request Information Collection Request Title: COVID-19 
Provider Relief Programs Application and Attestation Portal, and Claims 
Reimbursement Submission Activities

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 October 
22, 2021.

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

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
draft instruments, email [email protected] or call Lisa Wright-
Solomon, the HRSA Information Collection Clearance Officer at (301) 
443-1984.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the information request collection title 
for reference.
    Information Collection Request Title: COVID-19 Provider Relief 
Programs Application and Attestation Portal, and Claims Reimbursement 
Submission Activities, OMB No. 0906-XXXX.
    Abstract: HRSA administers the Provider Relief Programs (which 
includes the Provider Relief Fund (PRF), the American Rescue Plan Act 
Rural (ARPA-R) payments, the COVID-19 Coverage Assistance Fund (CAF), 
and the COVID-19 Claims Reimbursement to Health Care Providers and 
Facilities for Testing, Treatment, and Vaccine Administration for the 
Uninsured (Uninsured Program or UIP). The

[[Page 47120]]

Provider Relief Programs disbursed, and are continuing to disburse, 
funds to eligible healthcare providers through two pathways: (1) Direct 
provider payments via the PRF and ARPA-R payments, and (2) claims 
reimbursement via the CAF and the UIP. This information collection 
includes four components: (1) The PRF and ARPA-R application portal; 
(2) the PRF and ARPA-R attestation portal; (3) the CAF application 
portal; and (4) the UIP application portal. To date, information for 
these programs has been collected under a Paperwork Reduction Act 
waiver executed pursuant to public health emergency authorities. HRSA 
is seeking comments regarding the CAF and the UIP for the first time. 
These information collections support administration of the Provider 
Relief Programs including the PRF, the Uninsured Program, and the CAF 
(funds for these three programs were appropriated under the Coronavirus 
Aid, Relief, and Economic Security Act (Pub. L. 116-136), Paycheck 
Protection Program and Health Care Enhancement Act (Pub. L. 116-139), 
Coronavirus Response and Relief Supplemental Appropriations Act 
(Division M of Pub. L. 116-260)), and the ARPA-R payments (funds were 
appropriated under the American Rescue Plan Act of 2021, Pub. L. 117-
2).
    Need and Proposed Use of the Information: Providers who apply for 
Provider Relief Programs (i.e., PRF, ARPA-R, CAF, and UIP payments) 
must apply for direct provider payments or claims reimbursement and 
attest to a set of Terms and Conditions to enable HRSA's appropriate 
disbursement and oversight of recipients' use of funds.
    Information collected will allow for (1) assessing if recipients 
have met statutory and programmatic requirements; (2) conducting 
audits; (3) gathering data required to calculate, disburse, and report 
on PRF, ARPA-R, CAF, and UIP payments; and (4) program evaluation. HRSA 
staff may also use information collected to identify and report on 
trends in the effect of the COVID-19 pandemic on health care providers 
and uninsured or underinsured patients throughout the United States.
    HHS makes publicly available the names of payment recipients and 
the aggregate amounts received, for all providers who attest to receipt 
of a payment and acceptance of the Terms and Conditions or who retain 
payments for more than 90 days and are deemed to have accepted the 
Terms and Conditions. By accepting funds, the recipient consents to HHS 
publicly disclosing the payments that recipient has received.
    Likely Respondents: Health care providers that apply to receive, or 
have applied to receive, PRF, ARPA-R, CAF, or UIP payments, and 
attested to the associated Terms and Conditions.
    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                    Average burden
            Form name                Number of     responses per       Total       per response    Total burden
                                    respondents     respondent       responses      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
Attestation Portal..............         130,000               1         130,000            0.25          32,500
Application Portal..............         130,000               1         130,000            1.00         130,000
CAF Application.................          15,000               1          15,000            1.00          15,000
UIP Application.................         280,000               1         280,000            5.60       1,568,000
                                 -------------------------------------------------------------------------------
    Total.......................         555,000  ..............         555,000  ..............       1,745,500
----------------------------------------------------------------------------------------------------------------

    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. 2021-18018 Filed 8-20-21; 8:45 am]
BILLING CODE 4165-15-P