Information Collection; Quality Assurance Requirements, 11794-11795 [2016-04941]

Download as PDF asabaliauskas on DSK3SPTVN1PROD with NOTICES 11794 Federal Register / Vol. 81, No. 44 / Monday, March 7, 2016 / Notices of the divestitures is not acceptable, the proposed Order requires Hikma to unwind the sale of rights to Renaissance and then divest the products to a Commission-approved acquirer within six months of the date the Order becomes final. The proposed Order further allows the Commission to appoint a trustee should the parties fail to divest the products as required. The proposed Consent Agreement and Order contain several provisions to help ensure that the divestitures are successful. The proposed Order requires that Hikma supply Renaissance with 5 mg, 10 mg, and 20 mg generic prednisone tablets and with generic lithium carbonate capsules for eighteen months while Hikma transfers the manufacturing technology to Renaissance’s facility. The proposed Order also requires Hikma to provide a back-up supply of active pharmaceutical ingredient for generic prednisone tablets should the need for it arise. To ensure the success of these divestitures, the proposed Order requires Hikma to provide transitional services to assist Renaissance in establishing its manufacturing capabilities and securing all of the necessary FDA approvals. The transitional services include technical assistance to manufacture the product in substantially the same manner and quality employed or achieved by Hikma, and advice and training from knowledgeable employees of the parties. In addition, to ensure that Hikma complies with the terms of the Consent Agreement, the Commission has appointed Owen Richards of Quantic Regulatory Services, LLC as the Interim Monitor. To remedy competitive concerns raised by the acquisition in the market for generic flecainide tablets, the proposed Order requires Hikma to divest its approximately 23% ownership interest in Unimark and to return to Unimark all rights it has to commercialize generic flecainide tablets in the United States. Unimark has selected another firm, Bion Pharma, of Princeton, New Jersey, to market generic flecainide tablets in the United States upon the product’s approval by the FDA. The purpose of this analysis is to facilitate public comment on the proposed Consent Agreement, and it is not intended to constitute an official interpretation of the proposed Order or to modify its terms in any way. By direction of the Commission. Donald S. Clark, Secretary. [FR Doc. 2016–04884 Filed 3–4–16; 8:45 am] BILLING CODE 6750–01–P VerDate Sep<11>2014 18:37 Mar 04, 2016 Jkt 238001 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). 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 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. AGENCY: 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. SUMMARY: 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 DATES: PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 Mr. Curtis E. Glover, Sr., Procurement Analyst, Contract Policy Division, at 202–501–1448 or email curtis.glover@ gsa.gov. FOR FURTHER INFORMATION CONTACT: 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. E:\FR\FM\07MRN1.SGM 07MRN1 Federal Register / Vol. 81, No. 44 / Monday, March 7, 2016 / Notices 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 DEPARTMENT OF DEFENSE GENERAL SERVICES ADMINISTRATION NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [OMB Control No. 9000–0102; Docket 2016– 0053; Sequence 20] 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. AGENCY: Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension to a previously approved information collection requirement concerning prompt payment. DATES: Submit comments on or before May 6, 2016. ADDRESSES: Submit comments identified by Information Collection 9000–0102, Prompt Payment, 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 9000–0102, Prompt Payment’’. Follow the instructions provided at the ‘‘Submit a Comment’’ screen. Please include your name, company name (if any), and ‘‘Information Collection 9000–0102, Prompt Payment’’ on your attached document. • Mail: General Services Administration, Regulatory Secretariat (MVCB), 1800 F Street NW., Washington, DC 20405. ATTN: Ms. Flowers/IC 9000–0102, Prompt Payment. Instructions: Please submit comments only and cite Information Collection 9000–0102, Prompt Payment, in all asabaliauskas on DSK3SPTVN1PROD with NOTICES VerDate Sep<11>2014 18:37 Mar 04, 2016 Jkt 238001 SUPPLEMENTARY INFORMATION: A. Purpose Information Collection; Prompt Payment SUMMARY: 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: Ms. Kathlyn Hopkins, Procurement Analyst, Office of Acquisition Policy, GSA 202– 969–7226 or email kathlyn.hopkins@ gsa.gov. Part 32 of the FAR and the clause at FAR 52.232–5, Payments Under FixedPrice Construction Contracts, require that contractors under fixed-price construction contracts certify, for every progress payment request, that payments to subcontractors/suppliers have been made from previous payments received under the contract and timely payments will be made from the proceeds of the payment covered by the certification, and that this payment request does not include any amount which the contractor intends to withhold from a subcontractor/supplier. Part 32 of the FAR and the clause at 52.232–27, Prompt Payment for Construction Contracts, further require that contractors on construction contracts: (a) Notify subcontractors/suppliers of any amounts to be withheld and furnish a copy of the notification to the contracting officer; (b) Pay interest to subcontractors/ suppliers if payment is not made by 7 days after receipt of payment from the Government, or within 7 days after correction of previously identified deficiencies; (c) Pay interest to the Government if amounts are withheld from subcontractors/suppliers after the Government has paid the contractor the amounts subsequently withheld, or if the Government has inadvertently paid the contractor for nonconforming performance; and (d) Include a payment clause in each subcontract which obligates the contractor to pay the subcontractor for satisfactory performance under its subcontract no later than seven days after such amounts are paid to the contractor, include an interest penalty clause which obligates the contractor to pay the subcontractor an interest penalty if payments are not made in a PO 00000 Frm 00058 Fmt 4703 Sfmt 9990 11795 timely manner, and include a clause requiring each subcontractor to include these clauses in each of its subcontractors and to require each of its subcontractors to include similar clauses in their subcontracts. These requirements are imposed by Public Law 100–496, the Prompt Payment Act Amendments of 1988. Contracting officers will be notified if the contractor withholds amounts from subcontractors/suppliers after the Government has already paid the contractor the amounts withheld. The contracting officer must then charge the contractor interest on the amounts withheld from subcontractors/suppliers. Federal agencies could not comply with the requirements of the law if this information were not collected. B. Annual Reporting Burden Respondents: 2,679. Responses per Respondent: 18.27. Total Responses: 48,950. Hours per Response: .11. Total Burden Hours: 5,384. 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. 9000–0102, Prompt Payment, in all correspondence. Dated: March 2, 2016. Lorin S. Curit, Director, Federal Acquisition Policy Division, Office of Governmentwide Acquisition Policy, Office of Acquisition Policy, Office of Governmentwide Policy. [FR Doc. 2016–04942 Filed 3–4–16; 8:45 am] BILLING CODE 6820–EP–P E:\FR\FM\07MRN1.SGM 07MRN1

Agencies

[Federal Register Volume 81, Number 44 (Monday, March 7, 2016)]
[Notices]
[Pages 11794-11795]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

-----------------------------------------------------------------------

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 
curtis.glover@gsa.gov.

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