82 FR 35528 - Information Collection; Federal Acquisition Regulation: Buy American, Trade Agreements, and Duty-Free Entry
DEPARTMENT OF DEFENSE
GENERAL SERVICES ADMINISTRATION
NATIONAL AERONAUTICS AND SPACE ADMINISTRATION Federal Register Volume 82, Issue 145 (July 31, 2017)
GENERAL SERVICES ADMINISTRATION
NATIONAL AERONAUTICS AND SPACE ADMINISTRATION
Federal Register Volume 82, Issue 145 (July 31, 2017)
| Page Range | 35528-35530 | |
| FR Document | 2017-16022 |
[Federal Register Volume 82, Number 145 (Monday, July 31, 2017)] [Notices] [Pages 35528-35530] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-16022] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF DEFENSE GENERAL SERVICES ADMINISTRATION NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [OMB Control No. 9000-0024; Docket 2017-0053; Sequence 2] Information Collection; Federal Acquisition Regulation: Buy American, Trade Agreements, and Duty-Free Entry 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, the Regulatory Secretariat Division (MVCB) will be submitting to the Office of Management and Budget (OMB) a request for revision and an extension to existing OMB clearances regarding the Buy American statute, Trade Agreements, and duty-free entry. DATES: Submit comments on or before September 29, 2017. ADDRESSES: Submit comments identified by Information Collection 9000- 0024, Buy American, Trade Agreements, and Duty-Free Entry, 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 9000-0024. Select the link ``Comment Now'' that corresponds with ``Information Collection 9000-0024, Buy American, Trade Agreements, and Duty-Free Entry. Follow the instructions provided on the screen. Please include your name, company name (if any), and ``Information Collection 9000-0024, Buy American, Trade Agreements, and Duty-Free Entry'' on your attached document. Mail: General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405. ATTN: Ms. Sosa/IC 9000-0024, Buy American, Trade Agreements, and Duty- Free Entry. Instructions: Please submit comments only and cite Information Collection 9000-0024, Buy American, Trade Agreements, and Duty-Free Entry, 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: Ms. Cecelia L. Davis, Procurement Analyst, Acquisition Policy Division, GSA (202) 219-0202 or email [email protected]. SUPPLEMENTARY INFORMATION: A. This information collection requirement pertains to information that an offeror must submit in response to [[Page 35529]] the requirements of the provisions and clauses in FAR 52.225 that relate to the following: * The Buy American statute (41 U.S.C. chapter 83 and E.O. 10582). * The Trade Agreements Act (19 U.S.C. 2501-2515), including the World Trade Organization Government Procurement Agreement and various free trade agreements. * The American Recovery and Reinvestment Act of 2009 (Pub. L. 111- 5) (Recovery Act). * Subchapters VIII and X of Chapter 98 of the Harmonized Tariff Schedule of the United States (19 U.S.C. 1202). a. 52.225-2, Buy American Certificate, as prescribed in FAR 25.1101 (a)(2), requires the offeror to identify in its proposal supplies that do not meet the definition of domestic end product. The Buy American statute does not apply to acquisitions of commercial information technology. b. 52.225-4, Buy American--Free Trade Agreements--Israeli Trade Act Certificate, as prescribed in FAR 25.1101(b)(2)(i), requires separate listing of foreign products that are eligible under a trade agreement, and listing of all other foreign end products. c. 52.225-6, Trade Agreements Certificate, as prescribed in FAR 25.1101(c)(2), requires the offeror to certify that all end products are either U.S.-made or designated country end products, except as listed in paragraph (b) of the provision. Offerors are not allowed to provide other than a U.S.-made or designated country end product, unless the requirement is waived. d. Construction provisions and clauses: 52.225-9, Buy American-Construction Materials 52.225-10, Notice of Buy American Requirement-- Construction Materials 52.225-11, Buy American--Construction Materials under Trade Agreements 52.225-12, Notice of Buy American Requirement-- Construction Materials under Trade Agreements 52.225-21, Required Use of American Iron, Steel and Manufactured Goods--Buy American--Construction Materials 52.225-23, Required Use of American Iron, Steel and Manufactured Goods--Buy American--Construction Materials under Trade Agreements. The listed provisions and clauses, as prescribed in FAR 25.1102(a) through (e), provide that an offeror/contractor requesting to use foreign construction material due to unreasonable cost of domestic construction material shall provide adequate information to permit evaluation of the request. e. 52.225-8, Duty-Free Entry (formerly OMB clearance 9000-0022), as prescribed in FAR 25.1101(e), requires the contractor to notify the contracting officer when it purchases foreign supplies, in order to determine whether the supplies should be duty-free. In addition, all shipping documents and containers must specify certain information to assure the duty-free entry of the supplies. B. Annual Reporting Burden 1. Buy American and Trade Agreements-Supplies: FAR Clause 52.225-2, Buy American Certificate, requires the offeror to identify in its proposal supplies for use in the United States that do not meet the definition of domestic end product. The Buy American statute does not apply to acquisitions of commercial information technology. Respondents: 3,306. Responses per Respondent: 5. Total Responses: 16,530. Hours per Response: .25. Total Burden Hours: 4,133. FAR Clause 52.225-4, Buy American-Free Trade Agreements-Israeli Trade Act Certificate, requires separate listing of foreign products that are eligible under a trade agreement, and listing of all other foreign end products. Respondents: 1,977. Responses per Respondent: 5. Total Responses: 9,885. Hours per Response: .25. Total Burden Hours: 2,471. FAR Clause 52.225-6, Trade Agreements Certificate, requires the offeror to certify that all end products are either U.S.-made or designated country end products, except as listed in paragraph (b) of the provision. Offerors are not allowed to provide other than a U.S.- made or designated country end product, unless the requirement is waived. Respondents: 397. Responses per Respondent: 2. Total Responses: 794. Hours per Response: .25. Total Burden Hours: 199. 2. Buy American and Trade Agreements--Construction provisions and clauses provide that an offeror/contractor requesting to use foreign construction material due to unreasonable cost of domestic construction material shall provide adequate information to permit evaluation of the request. --52.225-9, Buy American--Construction Materials --52.225-10, Notice of Buy American Requirements--Construction Materials --52.225-11, Buy American--Construction Materials under Trade Agreements --52.225-12, Notice of Buy American Requirements--Construction Materials under Trade Agreements --52.225-21, Required Use of American Iron, Steel and Manufactured Goods--Buy American--Construction Materials --52.225-23, Required Use of American Iron, Steel and Manufactured Goods--Buy American--Construction Materials under Trade Agreements Respondents: 853. Responses per Respondent: 2.3. Total Responses: 1,990. Hours per Response: 5. Total Burden Hours: 10,045. 3. Duty-Free Entry. The clause at FAR 52.225-8, Duty-Free Entry (formerly OMB clearance 9000-0022), is included in solicitations and contracts for supplies that may be imported into the United States and for which duty-free entry may be obtained in accordance with FAR 25.903(a), if the value of the acquisition (1) exceeds the simplified acquisition threshold; or (2) does not exceed the simplified acquisition threshold, but the savings from waiving the duty is anticipated to be more than the administrative cost of waiving the duty. The contracting officer analyzes the information submitted by the contractor to determine whether or not supplies should enter the country duty-free. Respondents: 1,330. Responses per Respondent: 10. Total Responses: 13,300. Hours per Response: 0.5. Total Burden Hours: 6,650. 4. Summary Respondents: 7,863. Responses per Respondent: 5.4. Total Responses: 42,499. Hours per Response: .5. Total Burden Hours: 23,497. 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 [[Page 35530]] 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. 9000-0024, Buy American, Trade Agreements, and Duty-Free Entry in all correspondence. Dated: July 25, 2017. Lorin S. Curit, Director, Federal Acquisition Policy Division, Office of Government- wide Acquisition Policy, Office of Acquisition Policy, Office of Government-wide Policy. [FR Doc. 2017-16022 Filed 7-28-17; 8:45 am] BILLING CODE 6820-EP-P
![35528 Federal Register / Vol. 82, No. 145 / Monday, July 31, 2017 / Notices
saline intravenous bags is a commodity divestitures is not acceptable, the and National Aeronautics and Space
product, and prices typically are proposed Order requires the parties to Administration (NASA).
inversely correlated with the number of unwind the sale of rights to Renaissance ACTION: Notice of request for public
competitors in each market. As the and then divest the products to a comments regarding an extension to an
number of suppliers offering a Commission-approved acquirer within existing OMB clearance.
therapeutically equivalent drug six months of the date the Order
increases, the price for that drug becomes final. The proposed Order SUMMARY: Under the provisions of the
generally decreases due to the direct further allows the Commission to Paperwork Reduction Act, the
competition between the existing appoint a trustee in the event the parties Regulatory Secretariat Division (MVCB)
suppliers and each additional supplier. fail to divest the products as required. will be submitting to the Office of
The Proposed Acquisition would The proposed Consent Agreement and Management and Budget (OMB) a
combine two of only four significant Order contain several provisions to help request for revision and an extension to
companies selling the product, likely ensure that the divestitures are existing OMB clearances regarding the
leading consumers to pay higher prices. successful. Baxter will supply Buy American statute, Trade
Customers also have indicated that the Renaissance with fluconazole in saline Agreements, and duty-free entry.
presence of an independent Claris has intravenous bags and milrinone in DATES: Submit comments on or before
allowed them to negotiate lower prices dextrose intravenous bags for up to five September 29, 2017.
for fluconazole bags. years while the company transfers the ADDRESSES: Submit comments
In addition, the Proposed Acquisition manufacturing technology to identified by Information Collection
likely would cause significant Renaissance or its contract 9000–0024, Buy American, Trade
anticompetitive harm to consumers by manufacturing designee. The proposed Agreements, and Duty-Free Entry, by
eliminating future competition that Order also requires Baxter to provide any of the following methods:
would otherwise have occurred if Baxter transitional services to Renaissance to • Regulations.gov: http://
and Claris remained independent in the assist it in establishing its www.regulations.gov.
market for milrinone in dextrose manufacturing capabilities and securing Submit comments via the Federal
intravenous bags. The evidence shows all of the necessary FDA approvals. eRulemaking portal by searching the
that the Proposed Acquisition, absent a These transitional services include OMB control number 9000–0024. Select
remedy, would eliminate an additional technical assistance to manufacture the link ‘‘Comment Now’’ that
independent entrant in the currently fluconazole in saline intravenous bags corresponds with ‘‘Information
concentrated market for milrinone in and milrinone in dextrose intravenous Collection 9000–0024, Buy American,
dextrose intravenous bags, which would bags in substantially the same manner Trade Agreements, and Duty-Free Entry.
have enabled customers to negotiate and quality employed or achieved by Follow the instructions provided on the
lower prices. Customers and Claris. It also includes advice and screen. Please include your name,
competitors have observed—and pricing training from knowledgeable employees company name (if any), and
data confirms—that the price of these of the parties. Under the proposed ‘‘Information Collection 9000–0024, Buy
pharmaceutical products decreases with Consent Agreement, the Commission American, Trade Agreements, and Duty-
new entry even after several other also will appoint an Interim Monitor. Free Entry’’ on your attached document.
suppliers have entered the market. The purpose of this analysis is to • Mail: General Services
Thus, absent a remedy, the Proposed facilitate public comment on the Administration, Regulatory Secretariat
Acquisition likely will cause U.S. Division (MVCB), 1800 F Street NW.,
proposed Consent Agreement, and it is
consumers to pay significantly higher Washington, DC 20405. ATTN: Ms.
not intended to constitute an official
prices for milrinone in dextrose Sosa/IC 9000–0024, Buy American,
interpretation of the proposed Order or
intravenous bags in the future. Trade Agreements, and Duty-Free Entry.
to modify its terms in any way.
V. The Consent Agreement Instructions: Please submit comments
By direction of the Commission.
only and cite Information Collection
The proposed Consent Agreement Donald S. Clark, 9000–0024, Buy American, Trade
effectively remedies the competitive Secretary. Agreements, and Duty-Free Entry, in all
concerns raised by the acquisition in [FR Doc. 2017–16017 Filed 7–28–17; 8:45 am] correspondence related to this
both markets at issue by requiring Claris BILLING CODE 6750–01–P collection. Comments received generally
to divest all its rights to fluconazole in
will be posted, without change, to
saline intravenous bags and milrinone
http://www.regulations.gov, including
in dextrose intravenous bags to
any personal and/or business
Renaissance. Renaissance is a DEPARTMENT OF DEFENSE
confidential information provided. To
pharmaceutical corporation that
GENERAL SERVICES confirm receipt of your comment(s),
develops, manufacturers, sells, and
ADMINISTRATION please check www.regulations.gov,
distributes injectable pharmaceutical
approximately two to three days after
products in the United States. The
NATIONAL AERONAUTICS AND submission to verify posting (except
parties must accomplish these
SPACE ADMINISTRATION allow 30 days for posting of comments
divestitures no later than ten days after
submitted by mail).
they consummate the Proposed
Acquisition. [OMB Control No. 9000–0024; Docket 2017– FOR FURTHER INFORMATION CONTACT: Ms.
The Commission’s goal in evaluating 0053; Sequence 2] Cecelia L. Davis, Procurement Analyst,
sradovich on DSKBCFCHB2PROD with NOTICES
possible purchasers of divested assets is Acquisition Policy Division, GSA (202)
Information Collection; Federal 219–0202 or email cecelia.davis@
to maintain the competitive Acquisition Regulation: Buy American,
environment that existed prior to the gsa.gov.
Trade Agreements, and Duty-Free
Proposed Acquisition. If the Entry SUPPLEMENTARY INFORMATION:
Commission determines that A. This information collection
Renaissance is not an acceptable AGENCY: Department of Defense (DOD), requirement pertains to information that
acquirer, or that the manner of the General Services Administration (GSA), an offeror must submit in response to
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![35530 Federal Register / Vol. 82, No. 145 / Monday, July 31, 2017 / Notices
information collection documents from recommendations must be submitted in approval. To comply with this
the General Services Administration, any one of the following ways: requirement, CMS is publishing this
Regulatory Secretariat Division (MVCB), 1. Electronically. You may send your notice.
1800 F Street NW., Washington, DC comments electronically to http://
Information Collection
20405, telephone 202–501–4755. www.regulations.gov. Follow the
Please cite OMB Control No. 9000– instructions for ‘‘Comment or 1. Type of Information Collection
0024, Buy American, Trade Agreements, Submission’’ or ‘‘More Search Options’’ Request: Revision of a currently
and Duty-Free Entry in all to find the information collection approved collection;
correspondence. document(s) that are accepting Title of Information Collection:
comments. Manufacturer Submission of Average
Dated: July 25, 2017. Sales Prices (ASP) Data for Medicare
Lorin S. Curit,
2. By regular mail. You may mail
written comments to the following Part B Drugs; Use: In accordance with
Director, Federal Acquisition Policy Division, Section 1847A of the Social Security
Office of Government-wide Acquisition
address: CMS, Office of Strategic
Operations and Regulatory Affairs, Act (the Act), Medicare Part B covered
Policy, Office of Acquisition Policy, Office drugs and biologicals not paid on a cost
of Government-wide Policy. Division of Regulations Development
Attention: Document Identifier/OMB or prospective payment basis are paid
[FR Doc. 2017–16022 Filed 7–28–17; 8:45 am]
Control Number lllRoom C4–26–05, based on the average sales price (ASP)
BILLING CODE 6820–EP–P of the drug or biological, beginning in
7500 Security Boulevard, Baltimore,
Maryland 21244–1850. Calendar Year (CY) 2005. The ASP data
To obtain copies of a supporting reporting requirements are specified in
DEPARTMENT OF HEALTH AND statement and any related forms for the Section 1927 of the Act. The reported
HUMAN SERVICES proposed collection(s) summarized in ASP data are used to establish the
this notice, you may make your request Medicare payment amounts. Form
Centers for Medicare & Medicaid using one of following: Number: CMS–10110 (OMB control
Services 1. Access CMS’ Web site address at number: 0938–0921); Frequency:
http://www.cms.hhs.gov/ Quarterly; Affected Public: Business or
[Document Identifiers: CMS–10110] other For-profits; Number of
PaperworkReductionActof1995.
2. Email your request, including your Respondents: 180; Total Annual
Agency Information Collection Responses: 720; Total Annual Hours:
Activities: Proposed Collection; address, phone number, OMB number,
and CMS document identifier, to 9360. (For policy questions regarding
Comment Request this collection contact Felicia Eggleston
Paperwork@cms.hhs.gov.
AGENCY: Centers for Medicare & 3. Call the Reports Clearance Office at at 410–786–9287.)
Medicaid Services. (410) 786–1326. Dated: July 25, 2017.
ACTION: Notice. FOR FURTHER INFORMATION CONTACT: William N. Parham, III,
William Parham at (410) 786–4669. Director, Paperwork Reduction Staff, Office
SUMMARY: The Centers for Medicare & of Strategic Operations and Regulatory
SUPPLEMENTARY INFORMATION:
Medicaid Services (CMS) is announcing Affairs.
an opportunity for the public to Contents [FR Doc. 2017–16016 Filed 7–28–17; 8:45 am]
comment on CMS’ intention to collect
This notice sets out a summary of the BILLING CODE 4120–01–P
information from the public. Under the
use and burden associated with the
Paperwork Reduction Act of 1995 (the
following information collections. More
PRA), federal agencies are required to DEPARTMENT OF HEALTH AND
detailed information can be found in
publish notice in the Federal Register HUMAN SERVICES
each collection’s supporting statement
concerning each proposed collection of
and associated materials (see Centers for Medicare & Medicaid
information (including each proposed
ADDRESSES).
extension or reinstatement of an existing Services
collection of information) and to allow CMS–10110 Manufacturer Submission [CMS–7045–N]
60 days for public comment on the of Average Sales Prices (ASP) Data for
proposed action. Interested persons are Medicare Part B Drugs Health Insurance MarketplaceSM,
invited to send comments regarding our Under the PRA (44 U.S.C. 3501– Medicare, Medicaid, and Children’s
burden estimates or any other aspect of 3520), federal agencies must obtain Health Insurance Programs;
this collection of information, including approval from the Office of Management Announcement of the Renewal of the
the necessity and utility of the proposed and Budget (OMB) for each collection of Charter for the Advisory Panel on
information collection for the proper information they conduct or sponsor. Outreach and Education (APOE)
performance of the agency’s functions, The term ‘‘collection of information’’ is
the accuracy of the estimated burden, AGENCY: Centers for Medicare &
defined in 44 U.S.C. 3502(3) and 5 CFR Medicaid Services (CMS), HHS.
ways to enhance the quality, utility, and 1320.3(c) and includes agency requests
clarity of the information to be ACTION: Notice.
or requirements that members of the
collected, and the use of automated public submit reports, keep records, or SUMMARY: This notice announces the
collection techniques or other forms of provide information to a third party. renewal of the charter of the Advisory
information technology to minimize the Section 3506(c)(2)(A) of the PRA Panel on Outreach and Education APOE
sradovich on DSKBCFCHB2PROD with NOTICES
information collection burden. requires federal agencies to publish a (the Panel) in accordance with the
DATES: Comments must be received by 60-day notice in the Federal Register Federal Advisory Committee Act. The
September 29, 2017. concerning each proposed collection of Panel advises and makes
ADDRESSES: When commenting, please information, including each proposed recommendations to the Secretary of the
reference the document identifier or extension or reinstatement of an existing U.S. Department of Health and Human
OMB control number. To be assured collection of information, before Services (HHS) and the Administrator of
consideration, comments and submitting the collection to OMB for the Centers for Medicare & Medicaid
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Document Created: 2017-07-29 00:21:26
Document Modified: 2017-07-29 00:21:26
| 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 September 29, 2017. | |
| Contact | Ms. Cecelia L. Davis, Procurement Analyst, Acquisition Policy Division, GSA (202) 219-0202 or email [email protected] | |
| FR Citation | 82 FR 35528 |
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