Agency Information Collection Activities: Proposed Collection; Comment Request
| Citation | 85 FR 71653 |
| Published date | 10 November 2020 |
| Record Number | 2020-24948 |
| Section | Notices |
| Court | Centers For Medicare & Medicaid Services,Health And Human Services Department |
71653
Federal Register / Vol. 85, No. 218 / Tuesday, November 10, 2020 / Notices
Control No. 9000–0135, Prospective
Subcontractor Requests for Bonds.
William F. Clark,
Director, Federal Acquisition Policy Division,
Office of Governmentwide Acquisition Policy,
Office of Acquisition Policy, Office of
Governmentwide Policy.
[FR Doc. 2020–24931 Filed 11–9–20; 8:45 am]
BILLING CODE 6820–EP–P
DEPARTMENT OF DEFENSE
GENERAL SERVICES
ADMINISTRATION
NATIONAL AERONAUTICS AND
SPACE ADMINISTRATION
[OMB Control No. 9000–0011; Docket No.
2020–0053; Sequence No. 8]
Submission for OMB Review;
Preaward Survey Forms (Standard
Forms 1403, 1404, 1405, 1406, 1407,
and 1408)
AGENCY
: Department of Defense (DOD),
General Services Administration (GSA),
and National Aeronautics and Space
Administration (NASA).
ACTION
: Notice.
SUMMARY
: Under the provisions of the
Paperwork Reduction Act, the
Regulatory Secretariat Division has
submitted to the Office of Management
and Budget (OMB) a request to review
and approve a revision and renewal of
a previously approved information
collection requirement regarding
preaward survey forms.
DATES
: Submit comments on or before
December 10, 2020.
ADDRESSES
: Written comments and
recommendations for this information
collection should be sent within 30 days
of publication of this notice to
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function.
Additionally submit a copy to GSA
through http://www.regulations.gov and
follow the instructions on the site. This
website provides the ability to type
short comments directly into the
comment field or attach a file for
lengthier comments.
Instructions: All items submitted
must cite OMB Control No. 9000–0011,
Preaward Survey Forms (Standard
Forms 1403, 1404, 1405, 1406, 1407,
and 1408). Comments received generally
will be posted without change to http://
www.regulations.gov, including any
personal and/or business confidential
information provided. To confirm
receipt of your comment(s), please
check www.regulations.gov,
approximately two-to-three days after
submission to verify posting. If there are
difficulties submitting comments,
contact the GSA Regulatory Secretariat
Division at 202–501–4755 or
GSARegSec@gsa.gov.
FOR FURTHER INFORMATION CONTACT
:
Zenaida Delgado, Procurement Analyst,
at telephone 202–969–7207, or
zenaida.delgado@gsa.gov.
SUPPLEMENTARY INFORMATION
:
A. OMB Control Number, Title, and
Any Associated Form(s)
9000–0011, Preaward Survey Forms
(Standard Forms 1403, 1404, 1405,
1406, 1407, and 1408).
B. Needs and Uses
Contracting officers, prior to award,
must make an affirmative determination
that the prospective contractor is
responsible, i.e., capable of performing
the contract. Before making such a
determination, the contracting officer
must have or obtain sufficient
information to establish that the
prospective contractor: Has adequate
financial resources; or the ability to
obtain such resources; is able to comply
with required delivery schedule; has a
satisfactory record of performance; has a
satisfactory record of integrity; and is
otherwise qualified and eligible to
receive an award under appropriate
laws and regulations. If such
information is not readily available to
the contracting officer, it is obtained
through a preaward survey conducted
by the contract administration office or
another organization designated by the
agency to conduct the surveys. The
necessary data is collected from
available data or through plant visits,
phone calls, and correspondence in
detail commensurate with the dollar
value and complexity of the
procurement. This clearance covers the
information that prospective contractors
must provide to ensure proper
completion of the following preaward
survey forms prescribed by the Federal
Acquisition Regulation (FAR):
•Standard Form 1403 Preaward
Survey of Prospective Contractor
(General)
•Standard Form 1404 Preaward
Survey of Prospective Contractor
(Technical)
•Standard Form 1405 Preaward
Survey of Prospective Contractor
(Production)
•Standard Form 1406 Preaward
Survey of Prospective Contractor
(Quality Assurance)
•Standard Form 1407 Preaward
Survey of Prospective Contractor
(Financial Capability)
•Standard Form 1408 Preaward
Survey of Prospective Contractor
(Accounting System)
C. Common Form
This information collection is being
converted into a common form. The
General Services Administration is the
sponsor agency of this common form.
All executive agencies covered by the
Federal Acquisition Regulation will use
this common form. Each executive
agency will report their agency burden
separately, and the reported information
will be available at Reginfo.gov.
D. Annual Burden
General Services Administration
Respondents: 107.
Total Annual Responses: 107.
Total Burden Hours: 2,568.
E. Public Comment
A 60-day notice was published in the
Federal Register at 85 FR 55290 on
September 4, 2020. No comments were
received.
Obtaining Copies: Requesters may
obtain a copy of the information
collection documents from the GSA
Regulatory Secretariat Division, by
calling 202–501–4755 or emailing
GSARegSec@gsa.gov. Please cite OMB
Control No. 9000–0011, Preaward
Survey Forms (Standard Forms 1403,
1404, 1405, 1406, 1407, and 1408).
William F. Clark,
Director, Federal Acquisition Policy Division,
Office of Governmentwide Acquisition Policy,
Office of Acquisition Policy, Office of
Governmentwide Policy.
[FR Doc. 2020–24932 Filed 11–9–20; 8:45 am]
BILLING CODE 6820–EP–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–2552–10]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
AGENCY
: Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION
: Notice.
SUMMARY
: The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
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71654
Federal Register / Vol. 85, No. 218 / Tuesday, November 10, 2020 / Notices
information from the public. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information (including each proposed
extension or reinstatement of an existing
collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates or any other aspect of
this collection of information, including
the necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions,
the accuracy of the estimated burden,
ways to enhance the quality, utility, and
clarity of the information to be
collected, and the use of automated
collection techniques or other forms of
information technology to minimize the
information collection burden.
DATES
: Comments must be received by
January 11, 2021.
ADDRESSES
: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to http://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number ll, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
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/PRA-
Listing.html.
2. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT
:
William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION
:
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–2552–10 Hospital and Health
Health Care Complex Cost Report
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: Revision of a currently
approved collection; Title of
Information Collection: Hospital and
Health Health Care Complex Cost
Report; Use: CMS requires the Form
CMS–2552–10 to determine a hospital’s
reasonable cost incurred in furnishing
medical services to Medicare
beneficiaries and calculate the hospital
reimbursement. Hospitals paid under a
prospective payment system (PPS) may
receive reimbursement in addition to
the PPS for hospital-specific
adjustments such as Medicare
reimbursable bad debts,
disproportionate share, uncompensated
care, direct and indirect medical
education costs, and organ acquisition
costs.
CMS uses the Form CMS–2552–10 for
rate setting; payment refinement
activities, including developing a
hospital market basket; and Medicare
Trust Fund projections; and to support
program operations. Additionally, the
Medicare Payment Advisory
Commission (MedPAC) uses the
hospital cost report data to calculate
Medicare margins (a measure of the
relationship between Medicare’s
payments and providers’ Medicare
costs) and analyze data to formulate
Medicare Program recommendations to
Congress.
We welcome comments on our
burden estimates for the information
collection request. Form Number: CMS–
2552–10 (OMB control number: 0938–
0050); Frequency: Occasionally;
Affected Public: Private Sector; Business
or other for-profit and not-for-profit
institutions; Number of Respondents:
6.013; Total Annual Responses: 6,013;
Total Annual Hours: 4,173,022. (For
policy questions regarding this
collection contact Gail Duncan at 410–
786–7278.)
Dated: November 4, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2020–24948 Filed 11–9–20; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–1264]
Enhancing the Diversity of Clinical
Trial Populations—Eligibility Criteria,
Enrollment Practices, and Trial
Designs; Guidance for Industry;
Availability
AGENCY
: Food and Drug Administration,
HHS.
ACTION
: Notice of availability.
SUMMARY
: The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled
‘‘Enhancing the Diversity of Clinical
Trial Populations—Eligibility Criteria,
Enrollment Practices, and Trial
Designs.’’ This guidance recommends
approaches that sponsors of clinical
trials intended to support a new drug
application or a biologics license
application can take to increase
enrollment of underrepresented
populations in their clinical trials. This
guidance is being issued, in part, to
satisfy the mandates of the FDA
Reauthorization Act of 2017 (FDARA).
This guidance finalizes the draft
guidance of the same title issued on
June 7, 2019.
DATES
: The announcement of the
guidance is published in the Federal
Register on November 10, 2020.
ADDRESSES
: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
Electronic Submissions
Submit electronic comments in the
following way:
•Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
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