Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tropical Disease Priority Review Vouchers, 15619-15620 [2019-07464]
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Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Notices
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ website address at
website address at https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.html.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
khammond on DSKBBV9HB2PROD with NOTICES
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–1045 Medicare Uniform
Institutional Provider Bill and
Supporting Regulations in 42 CFR
424.5
Under the PRA (44 U.S.C. 3501–
3520), federal agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
The term ‘‘collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Information Collection
1. Type of Information Collection
Request: Extension without change of a
currently approved collection; Title of
Information Collection: Medicare
Uniform Institutional Provider Bill and
Supporting Regulations in 42 CFR
424.5; Use: Section 42 CFR 424.5(a)(5)
requires providers of services to submit
a claim for payment prior to any
Medicare reimbursement. Charges billed
are coded by revenue codes. The bill
specifies diagnoses according to the
International Classification of Diseases,
Tenth Edition (ICD–10) code. Inpatient
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procedures are identified by ICD–10
codes, and outpatient procedures are
described using the CMS Common
Procedure Coding System (HCPCS).
These are standard systems of
identification for all major health
insurance claims payers. Submission of
information on the UB–04 CMS–1450
permits Medicare Part A MACs to
receive consistent data for proper
payment. Medicare receives over 99.97
percent of the claims submitted by
institutional providers electronically.
CMS only accepts electronic claims in
the Accredited Standards Committee
(ASC) Health Insurance Portability and
Accountability Act (HIPAA) 837 format
for institutional providers unless the
provider meets CMS requirements to
submit paper claims. With the uniform
bill, we have been able to achieve a
more uniform and a more automated bill
processing system for Medicare
institutional and providers. The UB–04
CMS–1450 is managed by the National
Uniform Billing Committee (NUBC),
sponsored by the American Hospital
Association. Most payers are
represented on this body, and the UB–
04 is widely used in the industry.
Medicare Part A MACs use the
information on the UB–04 CMS–1450 to
determine whether to make Medicare
payment for the services provided, the
payment amount, and whether or not to
apply deductibles to the claim. The
same method is also used by other
payers. CMS is also a secondary user of
data. CMS uses the information to
develop a database, which is used to
update, and revise established payment
schedules and other payment rates for
covered services. CMS also uses the
information to conduct studies and
reports. Form Number: CMS–1045
(OMB control number: 0938–0997);
Frequency: Yearly; Affected Public:
State, Local, or Tribal Governments;
Number of Respondents: 53,111; Total
Annual Responses: 204,138,881; Total
Annual Hours: 1,797,958. (For policy
questions regarding this collection
contact Mohammad B Ullah at 410–
786–4143.)
Dated: April 10, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2019–07491 Filed 4–15–19; 8:45 am]
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15619
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0530]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Tropical Disease
Priority Review Vouchers
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by May 16,
2019.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0822. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Tropical Disease Priority Review
Vouchers
OMB Control Number 0910–0822—
Revision
Section 524 of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
360n) is designed to encourage
development of new drug or biological
products for prevention and treatment
of certain tropical diseases affecting
millions of people throughout the world
and makes provisions for awarding
priority review vouchers for future
applications to sponsors of tropical
disease products. By enacting section
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16APN1
15620
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Notices
524 of the FD&C Act, Congress intended
to stimulate new drug development for
drugs to treat certain tropical diseases
for which there are no or few available
treatments by offering additional
incentives for obtaining FDA approval
for pharmaceutical treatments for these
diseases. Under section 524 of the FD&C
Act, a sponsor of a human drug
application for a qualified tropical
disease may be eligible for a voucher
that can be used to obtain a priority
review for any application submitted
under section 505(b)(1) of the FD&C Act
(21 U.S.C. 355(b)(1)) or section 351 of
the Public Health Service Act (the PHS
Act).
Accordingly, we have developed the
guidance document entitled, ‘‘Guidance
for Industry (GFI): Tropical Disease
Priority Review Vouchers.’’ The
guidance explains how FDA will
implement the provisions of section 524
include new information collection
established by section 611 of the FDA
Reauthorization Act of 2017 (FDARA).
As amended, section 524 of the FD&C
Act requires the sponsor of a tropical
disease product application to include
an attestation regarding its eligibility for
a priority review voucher. The guidance
is available at https://www.fda.gov/
downloads/Drugs/Guidances/
UCM080599.pdf.
Description of Respondents: Sponsors
submitting applications under section
505(b)(1) of the FD&C Act or section 351
of the PHS Act.
In the Federal Register of November
7, 2018 (83 FR 55720), we published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
We estimate the burden of the
information collection as follows:
of the FD&C Act, how sponsors may use
priority review vouchers, and how
priority review vouchers may be
transferred to other sponsors. The
guidance also explains eligibility
criteria for tropical disease drug product
applications submitted under section
505(b)(1) of the FD&C Act and section
351 of the PHS Act, and provides
instructions to sponsors on how they
may:
• Request a priority review voucher;
and
• notify FDA of their intent to use a
priority review voucher, including the
date on which the sponsor intends to
submit the application.
The guidance also explains that
transfer of a priority review voucher
from one sponsor to another is
permitted and that each transfer should
be documented with a letter of transfer.
Finally, the guidance will be revised to
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Information collection activity
Total hours
Priority Review Voucher Request ........................................
Notifications of Intent to Use a Voucher ..............................
Letters Indicating the Transfer of a Voucher Letter ............
Acknowledging the Receipt of a Transferred Voucher ........
Attestation of Eligibility .........................................................
5
5
2
2
5
1
1
1
1
1
5
5
2
2
5
8
8
8
8
2
40
40
16
16
10
Total ..............................................................................
........................
........................
........................
........................
122
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
We have increased our burden
estimate since last approval to account
for attestations added by FDARA;
however, all other information
collection elements remain unchanged.
Dated: April 10, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–07464 Filed 4–15–19; 8:45 am]
BILLING CODE 4164–01–P
SUMMARY:
The Food and Drug
Administration (FDA, Agency, or we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
DATES:
Fax written comments on the
collection of information by May 16,
2019.
Oversight of Clinical Investigations: A
Risk-Based Approach to Monitoring—
21 CFR Parts 312 and 812
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0733. Also
include the FDA docket number found
in brackets in the heading of this
document.
OMB Control Number 0910–0733—
Extension
ADDRESSES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0597]
khammond on DSKBBV9HB2PROD with NOTICES
Average
burden per
response
Total annual
responses
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Oversight of
Clinical Investigations: A Risk-Based
Approach to Monitoring
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
PO 00000
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This information collection supports
reporting and recordkeeping found in
Agency guidance. Under parts 312 and
812 (21 CFR parts 312 and 812),
sponsors are required to provide
appropriate oversight of their clinical
investigations to ensure adequate
protection of the rights, welfare, and
safety of human subjects and to ensure
the quality and integrity of the resulting
data submitted to FDA. As part of this
oversight, sponsors of clinical
investigations are required to monitor
the conduct and progress of their
clinical investigations. The regulations
do not specify how sponsors are to
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]]>Agencies
[Federal Register Volume 84, Number 73 (Tuesday, April 16, 2019)]
[Notices]
[Pages 15619-15620]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07464]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0530]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Tropical Disease
Priority Review Vouchers
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by May 16,
2019.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0822.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Tropical Disease Priority Review Vouchers
OMB Control Number 0910-0822--Revision
Section 524 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 360n) is designed to encourage development of new drug or
biological products for prevention and treatment of certain tropical
diseases affecting millions of people throughout the world and makes
provisions for awarding priority review vouchers for future
applications to sponsors of tropical disease products. By enacting
section
[[Page 15620]]
524 of the FD&C Act, Congress intended to stimulate new drug
development for drugs to treat certain tropical diseases for which
there are no or few available treatments by offering additional
incentives for obtaining FDA approval for pharmaceutical treatments for
these diseases. Under section 524 of the FD&C Act, a sponsor of a human
drug application for a qualified tropical disease may be eligible for a
voucher that can be used to obtain a priority review for any
application submitted under section 505(b)(1) of the FD&C Act (21
U.S.C. 355(b)(1)) or section 351 of the Public Health Service Act (the
PHS Act).
Accordingly, we have developed the guidance document entitled,
``Guidance for Industry (GFI): Tropical Disease Priority Review
Vouchers.'' The guidance explains how FDA will implement the provisions
of section 524 of the FD&C Act, how sponsors may use priority review
vouchers, and how priority review vouchers may be transferred to other
sponsors. The guidance also explains eligibility criteria for tropical
disease drug product applications submitted under section 505(b)(1) of
the FD&C Act and section 351 of the PHS Act, and provides instructions
to sponsors on how they may:
Request a priority review voucher; and
notify FDA of their intent to use a priority review
voucher, including the date on which the sponsor intends to submit the
application.
The guidance also explains that transfer of a priority review
voucher from one sponsor to another is permitted and that each transfer
should be documented with a letter of transfer. Finally, the guidance
will be revised to include new information collection established by
section 611 of the FDA Reauthorization Act of 2017 (FDARA). As amended,
section 524 of the FD&C Act requires the sponsor of a tropical disease
product application to include an attestation regarding its eligibility
for a priority review voucher. The guidance is available at https://www.fda.gov/downloads/Drugs/Guidances/UCM080599.pdf.
Description of Respondents: Sponsors submitting applications under
section 505(b)(1) of the FD&C Act or section 351 of the PHS Act.
In the Federal Register of November 7, 2018 (83 FR 55720), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of the information collection as follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Information collection activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Priority Review Voucher Request. 5 1 5 8 40
Notifications of Intent to Use a 5 1 5 8 40
Voucher........................
Letters Indicating the Transfer 2 1 2 8 16
of a Voucher Letter............
Acknowledging the Receipt of a 2 1 2 8 16
Transferred Voucher............
Attestation of Eligibility...... 5 1 5 2 10
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 122
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
We have increased our burden estimate since last approval to
account for attestations added by FDARA; however, all other information
collection elements remain unchanged.
Dated: April 10, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-07464 Filed 4-15-19; 8:45 am]
BILLING CODE 4164-01-P
