81 FR 11794 - Information Collection; Quality Assurance Requirements

DEPARTMENT OF DEFENSE
GENERAL SERVICES ADMINISTRATION
NATIONAL AERONAUTICS AND SPACE ADMINISTRATION

Federal Register Volume 81, Issue 44 (March 7, 2016)

Page Range		11794-11795
FR Document		2016-04941

Under the provisions of the Paperwork Reduction Act, Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement concerning quality assurance requirements.

Federal Register, Volume 81 Issue 44 (Monday, March 7, 2016)

[Federal Register Volume 81, Number 44 (Monday, March 7, 2016)]
[Notices]
[Pages 11794-11795]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-04941]


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DEPARTMENT OF DEFENSE

GENERAL SERVICES ADMINISTRATION

NATIONAL AERONAUTICS AND SPACE ADMINISTRATION

[OMB Control No. 9000-0077; Docket 2016-0053; Sequence 13]


Information Collection; Quality Assurance Requirements

AGENCY: Department of Defense (DOD), General Services Administration 
(GSA), and National Aeronautics and Space Administration (NASA).

ACTION: Notice of request for public comments regarding an extension to 
an existing OMB clearance.

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SUMMARY: Under the provisions of the Paperwork Reduction Act, 
Regulatory Secretariat Division will be submitting to the Office of 
Management and Budget (OMB) a request to review and approve an 
extension of a previously approved information collection requirement 
concerning quality assurance requirements.

DATES: Submit comments on or before May 6, 2016.

ADDRESSES: Submit comments identified by Information Collection 9000-
0077, Quality Assurance Requirements, by any of the following methods:
     Regulations.gov: http://www.regulations.gov. Submit 
comments via the Federal eRulemaking portal by searching the OMB 
control number. Select the link ``Submit a Comment'' that corresponds 
with ``Information Collection 9000-0077, Quality Assurance 
Requirements''. Follow the instructions provided at the ``Submit a 
Comment'' screen. Please include your name, company name (if any), and 
``Information Collection 9000-0077, Quality Assurance Requirements'' on 
your attached document.
     Mail: General Services Administration, Regulatory 
Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405. 
ATTN: Ms. Flowers/IC 9000-0077, Quality Assurance Requirements.
    Instructions: Please submit comments only and cite Information 
Collection 9000-0077, Quality Assurance Requirements, in all 
correspondence related to this collection. 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 
(except allow 30 days for posting of comments submitted by mail).

FOR FURTHER INFORMATION CONTACT: Mr. Curtis E. Glover, Sr., Procurement 
Analyst, Contract Policy Division, at 202-501-1448 or email 
[email protected].

SUPPLEMENTARY INFORMATION: 

A. Purpose

    Supplies and services acquired under Government contracts must 
conform to the contract's quality and quantity requirements. FAR Part 
46 prescribes inspection, acceptance, warranty, and other measures 
associated with quality requirements. Standard clauses related to 
inspection require the contractor to provide and maintain an inspection 
system that is acceptable to the Government; gives the Government the 
right to make inspections and test while work is in process; and 
requires the contractor to keep complete, and make available to the 
Government, records of its inspection work.

B. Annual Reporting Burden

    Respondents: 138,292.
    Responses Per Respondent: 1.03226.
    Total Responses: 142,753.
    Hours Per Response: .83511.
    Total Burden hours: 119,214.

C. Public Comments

    Public comments are particularly invited on: Whether this 
collection of information is necessary for the proper performance of 
functions of the FAR, and whether it will have practical utility; 
whether our estimate of the public burden of this collection of 
information is accurate, and based on valid assumptions and 
methodology; ways to enhance the quality, utility, and clarity of the 
information to be collected; and ways in which we can minimize the 
burden of the collection of information on those who are to respond, 
through the use of appropriate technological collection techniques or 
other forms of information technology.
    Obtaining Copies of Proposals: Requesters may obtain a copy of the 
information collection documents from the General Services 
Administration, Regulatory Secretariat Division (MVCB), 1800 F Street 
NW., Washington, DC 20405, telephone 202-501-4755. Please cite OMB 
Control No. 9000-0077, Quality Assurance Requirements, in all 
correspondence.


[[Page 11795]]


    Dated: March 2, 2016.
Lorin S. Curit,
Director, Federal Acquisition Policy, Office of Governmentwide 
Acquisition Policy, Office of Acquisition Policy, Office of 
Governmentwide Policy.
[FR Doc. 2016-04941 Filed 3-4-16; 8:45 am]
 BILLING CODE 6820-EP-P

11794 Federal Register / Vol. 81, No. 44 / Monday, March 7, 2016 / Notices

of the divestitures is not acceptable, the DEPARTMENT OF DEFENSE check www.regulations.gov,
proposed Order requires Hikma to approximately two to three days after
unwind the sale of rights to Renaissance GENERAL SERVICES submission to verify posting (except
and then divest the products to a ADMINISTRATION allow 30 days for posting of comments
Commission-approved acquirer within submitted by mail).
six months of the date the Order NATIONAL AERONAUTICS AND
SPACE ADMINISTRATION FOR FURTHER INFORMATION CONTACT: Mr.
becomes final. The proposed Order
further allows the Commission to Curtis E. Glover, Sr., Procurement
[OMB Control No. 9000–0077; Docket 2016– Analyst, Contract Policy Division, at
appoint a trustee should the parties fail 0053; Sequence 13]
to divest the products as required. 202–501–1448 or email curtis.glover@
The proposed Consent Agreement and gsa.gov.
Information Collection; Quality
Order contain several provisions to help Assurance Requirements SUPPLEMENTARY INFORMATION:
ensure that the divestitures are
successful. The proposed Order requires AGENCY: Department of Defense (DOD), A. Purpose
that Hikma supply Renaissance with 5 General Services Administration (GSA),
mg, 10 mg, and 20 mg generic and National Aeronautics and Space Supplies and services acquired under
prednisone tablets and with generic Administration (NASA). Government contracts must conform to
lithium carbonate capsules for eighteen the contract’s quality and quantity
ACTION: Notice of request for public
months while Hikma transfers the requirements. FAR Part 46 prescribes
comments regarding an extension to an
manufacturing technology to inspection, acceptance, warranty, and
existing OMB clearance.
Renaissance’s facility. The proposed other measures associated with quality
Order also requires Hikma to provide a SUMMARY: Under the provisions of the requirements. Standard clauses related
back-up supply of active pharmaceutical Paperwork Reduction Act, Regulatory to inspection require the contractor to
ingredient for generic prednisone tablets Secretariat Division will be submitting provide and maintain an inspection
should the need for it arise. To ensure to the Office of Management and Budget system that is acceptable to the
the success of these divestitures, the (OMB) a request to review and approve Government; gives the Government the
proposed Order requires Hikma to an extension of a previously approved right to make inspections and test while
provide transitional services to assist information collection requirement work is in process; and requires the
Renaissance in establishing its concerning quality assurance contractor to keep complete, and make
manufacturing capabilities and securing requirements. available to the Government, records of
all of the necessary FDA approvals. The its inspection work.
DATES: Submit comments on or before
transitional services include technical May 6, 2016. B. Annual Reporting Burden
assistance to manufacture the product in
ADDRESSES: Submit comments Respondents: 138,292.
substantially the same manner and
identified by Information Collection
quality employed or achieved by Hikma, Responses Per Respondent: 1.03226.
9000–0077, Quality Assurance
and advice and training from Total Responses: 142,753.
Requirements, by any of the following
knowledgeable employees of the parties.
methods: Hours Per Response: .83511.
In addition, to ensure that Hikma
• Regulations.gov: http://
complies with the terms of the Consent Total Burden hours: 119,214.
www.regulations.gov. Submit comments
Agreement, the Commission has
via the Federal eRulemaking portal by C. Public Comments
appointed Owen Richards of Quantic
searching the OMB control number.
Regulatory Services, LLC as the Interim Public comments are particularly
Select the link ‘‘Submit a Comment’’
Monitor. invited on: Whether this collection of
that corresponds with ‘‘Information
To remedy competitive concerns information is necessary for the proper
Collection 9000–0077, Quality
raised by the acquisition in the market performance of functions of the FAR,
Assurance Requirements’’. Follow the
for generic flecainide tablets, the and whether it will have practical
instructions provided at the ‘‘Submit a
proposed Order requires Hikma to utility; whether our estimate of the
Comment’’ screen. Please include your
divest its approximately 23% ownership public burden of this collection of
name, company name (if any), and
interest in Unimark and to return to information is accurate, and based on
‘‘Information Collection 9000–0077,
Unimark all rights it has to valid assumptions and methodology;
Quality Assurance Requirements’’ on
commercialize generic flecainide tablets ways to enhance the quality, utility, and
your attached document.
in the United States. Unimark has clarity of the information to be
• Mail: General Services
selected another firm, Bion Pharma, of collected; and ways in which we can
Administration, Regulatory Secretariat
Princeton, New Jersey, to market generic minimize the burden of the collection of
Division (MVCB), 1800 F Street NW.,
flecainide tablets in the United States information on those who are to
Washington, DC 20405. ATTN: Ms.
upon the product’s approval by the respond, through the use of appropriate
Flowers/IC 9000–0077, Quality
FDA. technological collection techniques or
The purpose of this analysis is to Assurance Requirements.
Instructions: Please submit comments other forms of information technology.
facilitate public comment on the
proposed Consent Agreement, and it is only and cite Information Collection Obtaining Copies of Proposals:
9000–0077, Quality Assurance Requesters may obtain a copy of the
asabaliauskas on DSK3SPTVN1PROD with NOTICES

not intended to constitute an official
interpretation of the proposed Order or Requirements, in all correspondence information collection documents from
to modify its terms in any way. related to this collection. Comments the General Services Administration,
received generally will be posted Regulatory Secretariat Division (MVCB),
By direction of the Commission. without change to http:// 1800 F Street NW., Washington, DC
Donald S. Clark, www.regulations.gov, including any 20405, telephone 202–501–4755. Please
Secretary. personal and/or business confidential cite OMB Control No. 9000–0077,
[FR Doc. 2016–04884 Filed 3–4–16; 8:45 am] information provided. To confirm Quality Assurance Requirements, in all
BILLING CODE 6750–01–P receipt of your comment(s), please correspondence.

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Federal Register / Vol. 81, No. 44 / Monday, March 7, 2016 / Notices 11795

Dated: March 2, 2016. correspondence related to this timely manner, and include a clause
Lorin S. Curit, collection. Comments received generally requiring each subcontractor to include
Director, Federal Acquisition Policy, Office will be posted without change to http:// these clauses in each of its
of Governmentwide Acquisition Policy, Office www.regulations.gov, including any subcontractors and to require each of its
of Acquisition Policy, Office of personal and/or business confidential subcontractors to include similar
Governmentwide Policy. information provided. To confirm clauses in their subcontracts.
[FR Doc. 2016–04941 Filed 3–4–16; 8:45 am] receipt of your comment(s), please
These requirements are imposed by
BILLING CODE 6820–EP–P check www.regulations.gov,
approximately two to three days after Public Law 100–496, the Prompt
submission to verify posting (except Payment Act Amendments of 1988.
DEPARTMENT OF DEFENSE allow 30 days for posting of comments Contracting officers will be notified if
submitted by mail). the contractor withholds amounts from
GENERAL SERVICES subcontractors/suppliers after the
FOR FURTHER INFORMATION CONTACT: Ms.
ADMINISTRATION Government has already paid the
Kathlyn Hopkins, Procurement Analyst,
Office of Acquisition Policy, GSA 202– contractor the amounts withheld. The
NATIONAL AERONAUTICS AND
969–7226 or email kathlyn.hopkins@ contracting officer must then charge the
SPACE ADMINISTRATION
gsa.gov. contractor interest on the amounts
[OMB Control No. 9000–0102; Docket 2016– withheld from subcontractors/suppliers.
SUPPLEMENTARY INFORMATION:
0053; Sequence 20] Federal agencies could not comply with
A. Purpose the requirements of the law if this
Information Collection; Prompt
Part 32 of the FAR and the clause at information were not collected.
Payment
FAR 52.232–5, Payments Under Fixed-
AGENCY: Department of Defense (DOD), B. Annual Reporting Burden
Price Construction Contracts, require
General Services Administration (GSA), that contractors under fixed-price Respondents: 2,679.
and National Aeronautics and Space construction contracts certify, for every
Administration (NASA). progress payment request, that Responses per Respondent: 18.27.
ACTION: Notice of request for public payments to subcontractors/suppliers Total Responses: 48,950.
comments regarding an extension to an have been made from previous Hours per Response: .11.
existing OMB clearance. payments received under the contract
Total Burden Hours: 5,384.
and timely payments will be made from
SUMMARY: Under the provisions of the the proceeds of the payment covered by C. Public Comments
Paperwork Reduction Act, the the certification, and that this payment
Regulatory Secretariat Division will be request does not include any amount Public comments are particularly
submitting to the Office of Management which the contractor intends to invited on: Whether this collection of
and Budget (OMB) a request to review withhold from a subcontractor/supplier. information is necessary for the proper
and approve an extension to a Part 32 of the FAR and the clause at performance of functions of the FAR,
previously approved information 52.232–27, Prompt Payment for and whether it will have practical
collection requirement concerning Construction Contracts, further require utility; whether our estimate of the
prompt payment. that contractors on construction public burden of this collection of
DATES: Submit comments on or before contracts: information is accurate, and based on
May 6, 2016. (a) Notify subcontractors/suppliers of valid assumptions and methodology;
ADDRESSES: Submit comments any amounts to be withheld and furnish ways to enhance the quality, utility, and
identified by Information Collection a copy of the notification to the clarity of the information to be
9000–0102, Prompt Payment, by any of contracting officer; collected; and ways in which we can
the following methods: (b) Pay interest to subcontractors/ minimize the burden of the collection of
• Regulations.gov: http:// suppliers if payment is not made by 7 information on those who are to
www.regulations.gov. Submit comments days after receipt of payment from the
respond, through the use of appropriate
via the Federal eRulemaking portal by Government, or within 7 days after
technological collection techniques or
searching the OMB control number. correction of previously identified
deficiencies; other forms of information technology.
Select the link ‘‘Submit a Comment’’
that corresponds with ‘‘Information (c) Pay interest to the Government if Obtaining Copies of Proposals:
Collection 9000–0102, Prompt amounts are withheld from Requesters may obtain a copy of the
Payment’’. Follow the instructions subcontractors/suppliers after the information collection documents from
provided at the ‘‘Submit a Comment’’ Government has paid the contractor the the General Services Administration,
screen. Please include your name, amounts subsequently withheld, or if Regulatory Secretariat Division (MVCB),
company name (if any), and the Government has inadvertently paid 1800 F Street NW., Washington, DC
‘‘Information Collection 9000–0102, the contractor for nonconforming 20405, telephone 202–501–4755. Please
Prompt Payment’’ on your attached performance; and cite OMB Control No. 9000–0102,
document. (d) Include a payment clause in each Prompt Payment, in all correspondence.
• Mail: General Services subcontract which obligates the
asabaliauskas on DSK3SPTVN1PROD with NOTICES

Dated: March 2, 2016.
Administration, Regulatory Secretariat contractor to pay the subcontractor for
(MVCB), 1800 F Street NW., satisfactory performance under its Lorin S. Curit,
Washington, DC 20405. ATTN: Ms. subcontract no later than seven days Director, Federal Acquisition Policy Division,
Flowers/IC 9000–0102, Prompt after such amounts are paid to the Office of Governmentwide Acquisition Policy,
Payment. contractor, include an interest penalty Office of Acquisition Policy, Office of
Instructions: Please submit comments clause which obligates the contractor to Governmentwide Policy.
only and cite Information Collection pay the subcontractor an interest [FR Doc. 2016–04942 Filed 3–4–16; 8:45 am]
9000–0102, Prompt Payment, in all penalty if payments are not made in a BILLING CODE 6820–EP–P

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Document Created: 2018-02-02 15:07:36
Document Modified: 2018-02-02 15:07:36

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of request for public comments regarding an extension to an existing OMB clearance.
Dates		Submit comments on or before May 6, 2016.
Contact		Mr. Curtis E. Glover, Sr., Procurement Analyst, Contract Policy Division, at 202-501-1448 or email [email protected]
FR Citation		81 FR 11794

81 FR 11794 - Information Collection; Quality Assurance Requirements

DEPARTMENT OF DEFENSEGENERAL SERVICES ADMINISTRATIONNATIONAL AERONAUTICS AND SPACE ADMINISTRATION

Federal Register Volume 81, Issue 44 (March 7, 2016)

DEPARTMENT OF DEFENSE
GENERAL SERVICES ADMINISTRATION
NATIONAL AERONAUTICS AND SPACE ADMINISTRATION