Federal Register Vol. 83, No.13,

Background

On November 28, 2017, the Department of Commerce (Commerce) self-initiated a countervailing duty (CVD) investigation of common alloy aluminum sheet (common alloy sheet) from the People's Republic of China.1 Currently, the preliminary determination is due no later than February 1, 2018.

Section 703(b)(1) of the Tariff Act of 1930, as amended (the Act), requires Commerce to issue the preliminary determination in a countervailing duty investigation within 65 days after the date on which Commerce initiated the investigation. However, section 703(c)(1) of the Act permits Commerce to postpone the preliminary determination until no later than 130 days after the date on which Commerce initiated the investigation if: (A) The petitioner makes a timely request for a postponement; or (B) Commerce concludes that the parties concerned are cooperating, and determines that the investigation is extraordinarily complicated, and that additional time is necessary to make a preliminary determination.

As described in the Initiation Notice, Commerce self-initiated this investigation under section 702(a) of the Act on the basis of information available to it pertaining to 26 subsidy programs.2 On December 20, 2017, Commerce selected mandatory respondents to this CVD investigation and issued countervailing duty questionnaires.3 On January 8, 2018, we received responses to the affiliation section of the CVD questionnaire from mandatory respondents Henan Mingtai Aluminum Industrial Co. Ltd. (Henan Mingtai); Yong Jie New Material Co. Ltd. (Yong Jie New Material); and Zhengzhou Mingtai Industry Co Ltd. (Zhengzhou Mingtai).4 In their responses, Henan Mingtai, Yong Jie New Material, and Zhengzhou Mingtai stated that they intend to provide complete questionnaire responses on behalf of themselves and multiple cross-owned entities.5 Given the large number of subsidy programs that Commerce is investigating in this proceeding, many of which involve complex methodological issues, and the large number of mandatory respondents and their cross-owned entities that are participating in this investigation, Commerce determines that this investigation is extraordinarily complicated and additional time is necessary to issue a preliminary determination.

Therefore, in accordance with section 703(c)(1)(B) of the Act, Commerce is postponing the deadline for the preliminary determination to no later than 130 days after the date on which the investigation was initiated, i.e., April 9, 2018.6 Pursuant to section 705(a)(1) of the Act and 19 CFR 351.210(b)(1), the deadline for the final determination of this investigation will continue to be 75 days after the date of the preliminary determination.

This notice is issued and published pursuant to section 703(c)(2) of the Act and 19 CFR 351.205(f)(1).

On December 19, 2017, Commerce published in the Federal Register the preliminary determination of the CVD investigation of cast iron soil pipe fittings from China.1 On December 18, 2017, Wor-Biz International Trading Co., Ltd. (Anhui) (Wor-Biz) timely alleged that Commerce made a significant ministerial error in the Preliminary Determination.

A ministerial error, as defined in section 705(e) of the Tariff Act of 1930, as amended (the Act), includes “errors in addition, subtraction, or other arithmetic function, clerical errors resulting from inaccurate copying, duplication, or the like, and any other type of unintentional error which the administering authority considers ministerial.” 2 With respect to preliminary determinations, 19 CFR 351.224(e) provides that Commerce “will analyze any comments received and, if appropriate, correct any significant ministerial error by amending the preliminary determination. . . .” A significant ministerial error is defined as an error, the correction of which, singly or in combination with other errors, would result in: (1) A change of at least five absolute percentage points in, but not less than 25 percent of, the countervailable subsidy rate calculated in the original (erroneous) preliminary determination; or (2) a difference between a countervailable subsidy rate of zero (or de minimis) and a countervailable subsidy rate of greater than de minimis, or vice versa.3

Wor-Biz alleges that, in the Preliminary Determination, Commerce erred in calculating the benchmark prices for the Provision of Pig Iron for LTAR and the Provision of Ferrous Scrap for LTAR programs by unintentionally double-counting the distance for inland freight. We agree. Therefore, as explained in the Ministerial Error Memorandum issued concurrently with this notice,4 and pursuant to 19 CFR 351.224(e) and (g), Commerce is amending the Preliminary Determination to reflect the correction of a significant ministerial error made in the calculation of the subsidy rate for Wor-Biz.

We are amending the preliminary subsidy rate for Wor-Biz pursuant to 19 CFR 351.224(e). In addition, because the preliminary “All-Others” Rate was based on the weighted average of the subsidy rates calculated for Wor-Biz and Shanxi Xuanshi Industrial Group Co., Ltd,5 we are also amending the “All-Others” rate to account for the change in Wor-Biz's subsidy rate. Further, because the adverse facts available rate assigned to the non-cooperative respondent Shijiazhuang Chengmei Import & Export Co., Ltd. was determined using, in part, the highest calculated program-specific rates determined for the cooperating respondents,6 we are also amending the adverse facts available rate to account for our correction of Wor-Biz's Provision of Pig Iron for LTAR and Provision of Ferrous Scrap for LTAR program rates.7 The revised subsidy rates are as follows:

This amended preliminary determination is published in accordance with sections 705(e) and 777(i)(1) of the Act and 19 CFR 351.224(e) and (g).

On July 3, 2017, the Department of Commerce (Commerce) published a notice of opportunity to request an administrative review of the antidumping duty order on certain pasta from Italy.1 Pursuant to requests from interested parties,2 Commerce published in the Federal Register the notice of initiation of this antidumping duty administrative review with respect to the following companies for the period July 1, 2016, through June 30, 2017: Agritalia S.r.L. (Agritalia), Alessio Panarese Soceieta Agricola (Alessio), Antico Pastificio Morelli 1860 S.r.l. (Antico), Colussi SpA (Colussi), Francesco Tamma S.p.A. (Tamma), Ghigi 1870 S.p.A. (Ghigi), Ghigi Industria Agroalimentare in San Clemente S.r.l.,3 G.R.A.M.M. S.r.l. (GR.A.M.M.), Industria Alimentare Colavita S.p.A. (Indalco), La Molisana S.p.A. (La Molisana), Liguori Pastificio dal 1820 S.p.A. (Liguori), Pasta Zara S.p.A. (Zara), Pastificio Andalini S.p.A. (Andalini), Pastificio Fratelli DeLuca S.r.l. (DeLuca), Pastificio Menucci SpA (Menucci), Pastificio Zaffiri S.r.l. (Zaffiri), and Tesa SrL (Tesa).4

On September 18, 2017, La Molisana timely withdrew its request for a review.5 On November 13, 2017, Tamma timely withdrew its request for a review.6 On December 12, 2017, Andalini, DeLuca, GR.A.M.M., and Zaffiri timely withdrew their respective requests for an administrative review.7 No other party requested an administrative review of these particular companies.

Pursuant to 19 CFR 351.213(d)(1), the Secretary will rescind an administrative review, in whole or in part, if the parties that requested a review withdraw the request within 90 days of the date of publication of the notice of initiation of the requested review. All of the aforementioned withdrawal requests were timely submitted and no other interested party requested an administrative review of these particular companies. Therefore, in accordance with 19 CFR 351.213(d)(1), and consistent with our practice,8 we are rescinding this review of the antidumping duty order on certain pasta from Italy, in part, with respect to Andalini, DeLuca, GR.A.M.M., La Molisana, Tamma, and Zaffiri.

Commerce will instruct Customs and Border Protection (CBP) to assess antidumping duties on all appropriate entries. For the companies for which this review is rescinded, Andalini, DeLuca, GR.A.M.M., La Molisana, Tamma, and Zaffiri, antidumping duties shall be assessed at rates equal to the cash deposit of estimated antidumping duties required at the time of entry, or withdrawal from warehouse, for consumption, during the period July 1, 2016, through June 30, 2017, in accordance with 19 CFR 351.212(c)(1)(i). Commerce intends to issue appropriate assessment instructions directly to CBP 15 days after publication of this notice.

This notice serves as a reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping and/or countervailing duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping and/or countervailing duties occurred and the subsequent assessment of doubled antidumping duties.

This notice serves as a final reminder to parties subject to administrative protective orders (APOs) of their responsibility concerning the disposition of proprietary information disclosed under an APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.

This notice is issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Tariff Act of 1930, as amended, and 19 CFR 351.213(d)(4).

On November 20, 2017, Commerce published the Final Results of this review in the Federal Register.1 On December 1, 2017, Shin Yang Steel Co., Ltd. (Shin Yang) timely filed a ministerial error allegation concerning the Final Results and requested, pursuant to 19 CFR 351.224, that Commerce correct the alleged ministerial error.2

This notice is published pursuant to 41 U.S.C. 8503 (a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.

If the Committee approves the proposed addition, the entities of the Federal Government identified in this notice will be required to procure the product listed below from the nonprofit agency employing persons who are blind or have other severe disabilities.

The following product is proposed for addition to the Procurement List for production by the nonprofit agency listed:

The following products are proposed for deletion from the Procurement List:

On 12/15/2017 (82 FR 240), the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed deletions from the Procurement List.

After consideration of the relevant matter presented, the Committee has determined that the products listed below are no longer suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.

I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:

1. The action will not result in additional reporting, recordkeeping or other compliance requirements for small entities.

2. The action may result in authorizing small entities to furnish the products to the Government.

3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the products deleted from the Procurement List.

Accordingly, the following products are deleted from the Procurement List:

The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

Title of Collection: Teacher Education Assistance for College and Higher Education Grant Eligibility Regulations.

OMB Control Number: 1845-0084.

Type of Review: An extension of an existing information collection.

Respondents/Affected Public: State, Local, and Tribal Governments; Individuals or Households; Private Sector.

Total Estimated Number of Annual Responses: 232,324.

Total Estimated Number of Annual Burden Hours: 36,673.

Abstract: The Teacher Education Assistance for College and Higher Education (TEACH) Grant program is a non-need-based grant program that provides up to $4,000 per year to students who are enrolled in an eligible program and who agree to teach in a high-need field, at a low-income elementary or secondary school for at least four years within eight years of completing the program for which the Teach Grant was awarded. The TEACH Grant program regulations are required to ensure accountability of the program participants, both institutions and student recipients, for proper program administration, to determine eligibility to receive program benefits and to prevent fraud and abuse of program funds. The regulations include both record-keeping and reporting requirements. The record-keeping by the school allows for review of compliance with the regulation during on-site institutional reviews. The Department uses the required reporting to allow for close-out of institutions that are no longer participating or who lose eligibility to participate in the program.

The purpose of this meeting is to hear from informed speakers on environmental finance issues, proposed legislation, and EPA priorities; to discuss activities, progress, and preliminary recommendations with regard to current EFAB work projects; and to consider request for assistance from EPA program offices. Environmental finance discussions and presentations are expected on, but not limited to, the following topics: Predevelopment practices and funding tools that can assist local governments in evaluating public-private partnership as alternatives to current infrastructure delivery methods; developing metrics for measuring success of funding programs for water quality restoration in the Chesapeake Bay Watershed; financing and funding strategies that complement water system regionalization/consolidation; resilience investment and disaster recovery financing mechanisms; scoping and evaluation of a market-based Rural Alaska Waste Backhaul Service Program; and drinking water and clean water SRF funding to address lead fixture replacement projects. The meeting is open to the public; however, seating is limited. All members of the public who wish to attend the meeting must register, in advance, no later than Monday, January 26, 2018.

Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit http://www.epa.gov/dockets.

Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting comments and information to enable it to: (i) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (ii) evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (iii) enhance the quality, utility, and clarity of the information to be collected; and (iv) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval. At that time, EPA will issue another Federal Register notice to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB.

Abstract: The scope of this ICR is the electronic reporting components of CROMERR, which is designed to: (i) Allow EPA to comply with the Government Paperwork Elimination Act of 1998; (ii) provide a uniform, technology-neutral framework for electronic reporting across all EPA programs; (iii) allow EPA programs to offer electronic reporting as they become ready for CROMERR; and (iv) provide states with a streamlined process—together with a uniform set of standards—for approval of their electronic reporting provisions for all their EPA-authorized programs. Responses to the collection of information are voluntary. In order to accommodate CBI, the information collected must be in accordance with the confidentiality regulations set forth in 40 CFR part 2, subpart B. Additionally, EPA will ensure that the information collection procedures comply with the Privacy Act of 1974 and the OMB Circular 108.

Form Numbers: None.

Respondents/Affected Entities: Entities that report electronically to EPA and state or local government authorized programs; and state and local government authorized programs implementing electronic reporting.

Respondent's Obligation To Respond: Voluntary, required to obtain or retain a benefit (Cross-Media Electronic Reporting Rule (CROMERR) established to ensure compliance with the Government Paperwork Elimination Act (GPEA)).

Estimated Number of Respondents: 175,047 (total).

Frequency of Response: On occasion.

Total Estimated Burden: 112,717 hours (per year). Burden is defined at 5 CFR 1320.03(b).

Total Estimated Cost: $5,151,934 (per year), includes $4,615,463 in annualized labor costs and $536,471 in annualized capital or operation & maintenance costs.

Changes in Estimates: There is an increase of 63,113 hours in the total estimated respondent burden compared with the ICR currently approved by OMB. This increase occurred primarily because EPA accounted for the expected burden associated with the implementation of the e-Manifest system. (The e-Manifest Act extends the scope of the federal manifest program to include state hazardous waste, i.e., wastes regulated by a state but not EPA.) Under the e-Manifest system, all respondents that submit manifests electronically must first register with the Central Data Exchange (CDX). In addition, respondents that intend to use a PIN/Password must prepare an electronic subscriber agreement. EPA believes that the estimated number of respondents included in this ICR is a reasonable approximation of the actual respondent universe.

Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit http://www.epa.gov/dockets.

Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting comments and information to enable it to: (i) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (ii) evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (iii) enhance the quality, utility, and clarity of the information to be collected; and (iv) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval. At that time, EPA will issue another Federal Register notice to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB.

Abstract: EPA is seeking to combine multiple ICRs into a single ICR for all the recordkeeping and reporting related to the production, import, export, transformation, destruction, transhipment, and exempted uses of all ODS, and this merged renewal will allow for the option of electronic reporting and improvements to the electronic forms under Title VI of the Clean Air Act (CAA). Thus, for this ICR, EPA is renewing the existing ICR for class I ODS (ICR No. 1432.32; OMB Control No. 2060-0170) and transferring the burden under the ICR for class II ODS (EPA ICR No. 2014.07; OMB Control No. 2060-0498 Reporting and Recordkeeping Requirements of the HCFC Allowance System (Renewal)) and Methyl Bromide Critical Use Exemptions (EPA ICR No. 2031.08; OMB Control No. 2060-0482 Protection of Stratospheric Ozone: Request for Applications from Critical use Exemption for the Phase-out of Methyl Bromide (Renewal)). Both 2060-0498 and 2060-0482 will be discontinued once this ICR is approved.

This ICR covers the requirements under the Montreal Protocol on Substances that Deplete the Ozone Layer (Protocol) and Title VI of the CAA that establish limits on total U.S. production, import, and export of class I and class II controlled ODS (or controlled substances). Under its Protocol commitments, the United States has been obligated to cease production and import of class I controlled substances (chlorofluorocarbons and others) with exemptions for essential uses, critical uses of methyl bromide, quarantine and pre-shipment uses of methyl bromide, previously used material, and material that will be transformed or destroyed. The Protocol also establishes limits and reduction schedules leading to the eventual phaseout of class II controlled substances with limited exemptions for previously used material, and material that will be transformed, destroyed, or exported to developing countries.

Additionally, the CAA limits production and consumption of controlled substances which the EPA must adhere to and enforce. To implement the CAA provisions and satisfy commitments under the Montreal Protocol, the ODS phaseout regulations establish control measures for individual companies. EPA monitors company compliance through the recordkeeping and reporting requirements established in the regulations at 40 CFR part 82, subpart A.

EPA is also removing reporting elements that are no longer needed, revising others to address changes to a new electronic ODS Tracking System, and consolidating forms.

The Government Paperwork Elimination Act (GPEA, Pub. L. 105-277) requires that, when practicable, federal organizations use electronic forms, electronic filings, and electronic signatures to conduct official business with the public. EPA's Cross-Media Electronic Reporting Regulation (CROMERR) (October 13, 2005; 70 FR 59848; FRL-7977-1) provides that any requirement in Title 40 of the Code of Federal Regulations to submit a report directly to EPA can be satisfied with an electronic submission that meets certain conditions once the Agency publishes a notice that electronic document submission is available for that requirement.

In light of GPEA and CROMERR, this action will allow all manufacturers, importers, and processors of class I and class II ODS to use the internet, through EPA's Central Data Exchange (CDX), to submit ODS reports to the Agency. Companies will be able to register with EPA to submit their data electronically to the Agency via CDX and the Agency in turn will be able to communicate back electronically with submitters through a secure system. This promotes efficiency in communications and cost savings in submissions and correspondence. The adoption of electronic communications will reduce the reporting burden on industry by reducing both the cost and the time required to review, edit and transmit data to the Agency. All information sent via CDX will be transmitted securely to protect CBI. The Agency will also benefit from receiving electronic submissions. The electronic submission process through CDX will allow for the import of data into the ODS Tracking System, which will reduce the potential for human error that exists when data are entered by hand. Agency personnel will also be able to communicate more efficiently with submitters electronically, compared to using U.S. mail.

Upon receipt of the reports, the data is currently either entered or electronically imported into the ODS Tracking System. The ODS Tracking System is a secure database that maintains the data submitted to EPA and helps the Agency: (1) Maintain oversight over total production and consumption of controlled substances; (2) monitor compliance with limits and restrictions on production, imports, and trades and specific exemptions from the phaseout for individual U.S. companies; (3) enforce against illegal imports; and (4) assess and report on the U.S. phasedown caps established under the CAA and consistent with the Montreal Protocol.

EPA has implemented an electronic reporting system through CDX that allows regulated entities to prepare and submit data electronically. Coupled with the widespread use of the standardized forms, electronic reporting has improved data quality and made the reporting process efficient for both reporting companies and EPA.

EPA informs the respondents that they may assert claims of business confidentiality for any of the information they submit. Information claimed as confidential will be treated in accordance with the procedures for handling information claimed as confidential under 40 CFR part 2, subpart B, and will be disclosed to the extent, and by means of procedures, set forth in Subpart B. If no claim of confidentiality is asserted when the information is received by EPA, it may be made available to the public without further notice to the respondents (40 CFR 2.203). All information sent by the submitter via CDX is transmitted securely to protect CBI. The reporting tool guides the user through the process of submitting CBI. Documents containing information claimed as CBI must be submitted in an electronic format, in accordance with the recordkeeping requirements.

Form Numbers: Class I Producer Quarterly Report OMB Control No. 2060-0710, Class II Producer Quarterly Report OMB Control No. 2060-0498, Methyl Bromide Producer Quarterly Report OMB Control No. 2060-0482, Class I Importer Quarterly Report OMB Control No. 2060-0170, Class II Importer Quarterly Report OMB Control No. 2060-0498, Methyl bromide Importer Quarterly Report OMB Control No 2060-0482, Class I Exporter Annual Report OMB Control No. 2060-0170, Class II Exporter Quarterly Report OMB Control No. 2060-0498, Methyl Bromide Exporter Quarterly Report OMB Control No. 2060-0482, Second-Party Destruction Annual Report OMB Control No. 2060-0170, Second-Party Transformation Annual Report OMB Control No. 2060-0170, Class I Laboratory Supplier OMB Control No. 2060-0170, Methyl Bromide Pre-2005 Stocks Annual Report OMB Control No 2060-0482, Distributor of QPS Methyl Bromide Quarterly Report OMB Control No 2060-0482, Methyl Bromide Trades Report OMB Control No. 2060-0482, Methyl Bromide Sales of Critical Use Annual Report OMB Control No 2060-0482, Class II Request for Additional Consumption Allowances OMB Control No. 2060-0498, and Class II Trades Report OMB Control No. 2060-0498.

Respondents/Affected Entities: Entities required to comply with reporting and recordkeeping requirements include, chemical producers, importers, and exporters (CFCs and HCFCs); research and development (laboratories); and methyl bromide producers, importers, exporters, distributors, and applicators.

Respondent's Obligation To Respond: Mandatory—Section 603(b) of the Clean Air Act.

Estimated Number of Respondents: 106 (total).

Frequency of Response: Quarterly, annually, and as needed.

Total Estimated Burden: 3,811 hours (per year). Burden is defined at 5 CFR 1320.03(b).

Total Estimated Cost: $448,470 (per year), includes $13,082.00 annualized capital or operation & maintenance costs.

Changes in Estimates: There is a decrease of 1,644 hours in the total estimated respondent burden compared with the ICRs currently approved by OMB. This decrease compared to previous ICRs is because the merged ICR accounts for the transition from paper to electronic reporting and the decrease in the number of respondents. The reporting community continues to change as ODS are phased out. Specifically, we estimate fewer companies reporting on imports and exports of ODS. These updates are based on 2015 reporting activity. While the one-time burden associated with the transition to electronic reporting (i.e., CDX registration and electronic signature) temporarily increases burden, overall burden decreases because of the efficiencies associated with electronic reporting.

Title and Form Number: EIB 92-29 Export-Import Bank Report of Premiums Payable for Exporters Only.

OMB Number: 3048-0017.

Type of Review: Renewal.

Need and Use: The “Report of Premiums Payable for Exporters Only” form is used by exporters to report and pay premiums on insured shipments to various foreign buyers under the terms of the policy and to certify that premiums have been correctly computed and remitted. The `Report of Premiums Payable for Exporters Only' is used by EXIM to determine the eligibility of the shipment(s) and to calculate the premium due to EXIM for its support of the shipment(s) under its insurance program.

Affected Public: This form affects entities involved in the export of U.S. goods and services.

Monthly Number of Respondents: 2,600.

Estimated Time per Respondent: 15 minutes.

Annual Burden Hours: 7,800 hours.

Frequency of Reporting or Use: Monthly.

Reviewing Time per Year: 7,800 hours.

Average Wages per Hour: $42.50.

Average Cost per Year: $331,500.

Benefits and Overhead: 20%.

Total Government Cost: $397,800.

Title and Form Number: EIB 10-05 Notice of Claim and Proof of Loss, Medium Term Guarantee.

OMB Number: 3048-0035.

Type of Review: Regular.

Need and Use: This collection of information is necessary, pursuant to 12 U.S.C. 635(a)(1), to determine eligibility of the applicant for EXIM assistance. The information collected enables EXIM to determine the eligibility of the shipment(s) for insurance and to calculate the premium due to EXIM for its support of the shipment(s) under its insurance program.

Affected Public: This form affects entities involved in the export of U.S. goods and services.

Annual Number of Respondents: 65.

Estimated Time per Respondent: 1 hour.

Annual Burden Hours: 65 hours.

Frequency of Reporting of Use: As needed to request a claim payment.

Reviewing Time per Year: 65 hours.

Average Wages per Hour: $42.50.

Average Cost per Year: $2,762 (time*wages).

Benefits and Overhead: 20%.

Total Government Cost: $3,315.

Title and Form Number: EIB 10-03 Notice of Claim and Proof of Loss, Export Credit Insurance Policies.

OMB Number: 3048-0033.

Type of Review: Regular.

Need and Use: This collection of information is necessary, pursuant to 12 U.S.C. 635(a)(1), to determine if such claim complies with the terms and conditions of the relevant insurance policy.

Affected Public: This form affects entities involved in the export of U.S. goods and services.

Annual Number of Respondents: 300.

Estimated Time per Respondent: 45 minutes.

Annual Burden Hours: 225 hours.

Frequency of Reporting of Use: As needed to request claim payment.

Reviewing Time per Year: 300 hours.

Average Wages per Hour: $42.50.

Average Cost per Year: $12,750 (time*wages).

Benefits and Overhead: 20%.

Total Government Cost: $15,300.

Title and Form Number: EIB 92-27 Report of Overdue Accounts Under Short-Term Policies.

OMB Number: 3048-0027.

Type of Review: Regular.

Need and Use: The collection provides EXIM staff with the information necessary to monitor the borrower's payments for exported goods covered under its short- and medium term export credit insurance policies. It also alerts EXIM staff of defaults, so they can manage the portfolio in an informed manner.

Affected Public: This form affects entities involved in the export of U.S. goods and services.

Annual Number of Respondents: 745.

Estimated Time per Respondent: 15 minutes.

Annual Burden Hours for Respondents: 186.25 hours.

Frequency of Reporting or Use: Monthly, until completed.

Government Expenses:

Reviewing Time per Year: 186.25 hours.

Average Wages per Hour: $42.50.

Average Cost per Year: $7,915.63 (time * wages).

Benefits and Overhead: 20%.

Total Government Cost: $9,498.75.

Title and Form Number: EIB 92-79 Broker Registration Form.

OMB Number: 3048-0024.

Type of Review: Regular.

Need and Use: This form is used by insurance brokers to register with Export Import Bank. The form provides EXIM staff with the information necessary to make a determination of the eligibility of the broker to receive commission payments under Export Import Bank's credit insurance programs.

Affected Public: This form affects entities engaged in brokering export credit insurance policies.

Annual Number of Respondents: 17.

Estimated Time per Respondent: 15 minutes.

Frequency of Reporting or Use: Once every three years.

Annual Public Burden: 4.25 hours.

Reviewing Time/Hours: 2.

Responses per Year: 17.

Review Time per Year: 34 hours.

Average Wages per Hour: $42.5.

Wages per Year: $1,445.

Benefits & Overhead: 20%.

Total Government Cost: $1,734.

Titles and Form Number: EIB 92-34 Application for Short-Term Letter of Credit Insurance Policy.

OMB Number: 3048-0009.

Type of Review: Regular.

Need and Use: The information collected will provide information needed to determine compliance and creditworthiness for transaction requests submitted to the Export Import Bank.

Affected Public: This form affects entities involved in the export of U.S. goods and services.

Annual Number of Respondents: 11.

Estimated Time per Respondent: 1 hours.

Annual Burden Hours: 48 hours.

Frequency of Reporting or Use: As needed.

Reviewing Time per Year: 11 hours.

Average Wages per Hour: $42.50.

Average Cost per Year: $468 (time*wages).

Benefits and Overhead: 20%.

Total Government Cost: $561.

A. Purpose

This information collection requirement, OMB Control No. 9000-0018, currently titled “Certification of Independent Price Determination and Parent Company and Identifying Data,” is proposed to be retitled “Certification of Independent Price Determination, Contractor Code of Business Ethics and Compliance, and Preventing Personal Conflicts of Interest,” due to consolidation with two additional currently approved information collection requirements: OMB Control No. 9000-0164, Contractor Business Ethics Compliance Program and Disclosure Requirements; and OMB Control No. 9000-0183, Preventing Personal Conflicts of Interest for Contractor Employees Performing Acquisition Functions.

DoD, GSA and NASA analyzed the FY 2016 data from the Federal Procurement Data System (FPDS) to develop the estimated burden hours for this information collection.

This information collection requirement pertains to information that an offeror contractor must submit in response to the requirements of the following provisions and clauses in FAR 52.203:

1. Certification of Independent Price Determination (FAR 52.203-2). This clause requires the offeror to certify that the prices in the offer have been arrived at independently. Agencies are required to report under 41 U.S.C. 3101 (formerly 41 U.S.C. 252(b)(i)) and 10 U.S.C. 2305(d) suspected violations of the antitrust laws (e.g., collusive bidding, identical bids, uniform estimating systems, etc.) to the Attorney General.

As a first step in assuring that Government contracts are not awarded to firms violating such antitrust laws, offerors on Government contracts must complete the certificate of independent price determination. An offer will not be considered for award where the certificate has been deleted or modified. Deletions or modifications of the certificate and suspected false certificates are reported to the Attorney General (see FAR 3.103-2 Evaluating the Certification).

The information collection is required each time an offeror responds to a solicitation for firm-fixed price contract or fixed-price economic price adjustment contract unless the acquisition is: (1) Made under the simplified acquisition threshold; (2) at the request for technical proposals under two-step sealed bidding procedures; or (3) for utility services for which rates are set by law or regulation. The FAR rule requires a Certificate of Independent Price Determination so that contractors certify that the prices in their offer have been arrived at independently, have not been or will not be knowingly disclosed, and have not been submitted for the purpose of restricting competition. This clause does not apply to commercial items.

2. Contractor Code of Business Ethics and Conduct (FAR 52.203-13). This clause implements Government policy and Public Law 110-252, Title VI (Close the Contractor Fraud Loophole Act). It requires contractors to notify the respective agency Office of Inspector General when the contractor has credible evidence that the contractor's principal, employee, agent, or subcontractor committed a violation of certain Federal criminal laws, or a violation of the Civil False Claims Act.

The objective of the notification requirement is to emphasize the critical importance of integrity in contracting and reduce the occurrence of improper or criminal conduct in connection with the award and performance of Federal contracts and subcontracts. Information obtained from the notification requirements will be provided to the agency Inspector General by the contractor.

3. Preventing Personal Conflicts of Interest (FAR 52.203-16). In accordance with 41 U.S.C. 2303, this clause requires contractors and subcontractors to: (a) Identify and prevent personal conflicts of interest of their covered employees; and (b) prohibit covered employees who have access to non-public information by reason of performance on a Government contract from using such information for personal gain. Contractors are required to notify contracting officers whenever they become aware of any personal conflict of interest violations by a covered employee. The objective of the notification requirement is to emphasize the critical importance of integrity in contracting and reduce the occurrence of improper or criminal conduct in connection with the award and performance of Federal contracts and subcontracts. Information obtained from the notification requirements will be provided to the agency Inspector General by the contractor. In addition, contractors have the opportunity, in exceptional circumstances, to request mitigation or waiver of the personal conflict-of-interest standards. The information is used by the Government to evaluate the requested mitigation/waiver.

The information provided to and by contractors in accordance with the clause at FAR 52.203-16 is used by the contractor and the contracting officer to identify and mitigate personal conflicts of interest in compliance with Government policy to (a) identify and prevent personal conflicts of interest of covered employees; and (b) prohibit covered employees who have access to non-public information by reason of performance on a Government contract from using such information for personal gain (FAR 3.1102). A notice was published in the Federal Register at 82 FR 40582 on August 25, 2017. No comments were received.

1. Certification of Independent Price Determination (FAR 52.203-2).

Respondents: 24,270.

Responses annually: 30.

Total annual responses: 721,200.

Estimated hrs/response: .25.

Estimated total burden/hrs: 180,300.

2. Contractor Code of Business Ethics and Conduct (FAR 52.203-13).

Respondents: 278.

Responses per respondent: 1.

Total annual responses: 278.

Preparation hours per response: 60.

Total response burden hours: 16,680.

3. Preventing Personal Conflicts of Interest (FAR 52.203-16).

Respondents: 120.

Responses per respondent: 1.

Total responses: 120.

Burden hours per response: 30.

Total response burden hours: 3,600.

Recordkeeping burden:

Number of recordkeepers: 8,598.

Records per recordkeeper per year: 25.

Total annual records: 214,950.

Estimated hours per record: 2.0.

Total recordkeeping burden hours: 429,900.

4. Total (counting recordkeepers with respondents)

Recordkeepers and respondents: 33,266.

Responses: 721,598.

Hours (reporting and recordkeeping): 707,862.

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. 9000-0018, Certification of Independent Price Determination, Contractor Code of Business Ethics and Compliance, and Preventing Personal Conflicts of Interest, in all correspondence.

When the Government awards a cost-reimbursement construction contract, the contractor must submit to the contracting officer—and keep current a chart showing the general executive and administrative organization—the personnel to be employed in connection with the work under the contract, and their respective duties. The chart is used in the administration of the contract and as an aid in determining cost. The chart is used by contract administration personnel to assure the work is being properly accomplished at reasonable prices.

The burden hours under FAR 52.236-19 were reduced based on FY 2017 FPDS data that showed the actual number of respondents for this type of requirement. A notice published in the Federal Register at 82 FR 51254 on November 3, 2017. No comments were received.

Respondents: 19.

Responses per Respondent: 1.

Annual Responses: 19.

Hours per Response: .75.

Total Burden Hours: 14.

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. 9000-0064, Organization and Direction of Work, in all correspondence.

In accordance with 5 U.S.C. 4314(c)(4), the persons named below have been selected to serve on the PRB:

Gulf Coast Ecosystem Restoration Council, Scaggs, Benjamin, Acting Executive Director.

Environmental Protection Agency, Walker, Mary, Director Water Protection Division, EPA Region 4.

United States Coast Guard, Dana S. Tulis, Director of Incident Management & Preparedness Policy.

State of Mississippi, Rikard, Gary, Executive Director of the Mississippi Department of Environmental Quality.

State of Louisiana, Barnes, Chris, Legal Advisor, Coastal Activities.

Under the Paperwork Reduction Act of 1995 (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. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The OMB is particularly interested in comments that will help:

1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

3. Enhance the quality, utility, and clarity of the information to be collected; and

4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses.

5. Assess information collection costs.

DELTA Impact Recipient Monitoring and Assessment Tools—New—National Center for Injury Prevention and Control (NCIPC), Centers for Disease Control and Prevention (CDC).

The Centers for Disease Control and Prevention (CDC) seeks a three-year OMB approval for a new information collection project that involves 10 recipients (State Domestic Violence Coalitions) funded through CDC's Domestic Violence Prevention Enhancements and Leadership Through Alliances (DELTA) Impact Program cooperative agreement (NOFO CDC-RFA-CE18-1801). DELTA Impact recipients will report activity information to CDC annually. The Annual Progress Report (APR) tool and Prevention Infrastructure Assessment are designed to address four key program evaluation questions as well as performance reporting requirements established by CDC's Office of Financial Resources (OFR, formerly the Procurement and Grants Office).

Monitoring allows CDC to determine whether a recipient is meeting performance and budget goals and to make adjustments in the type and level of technical assistance provided to them, as needed, to support attainment of their performance measures. Program monitoring and program evaluation activities also allow CDC to identify and disseminate information about successful prevention strategies implemented by recipients.

These functions are central to the NCIPC's broad mission of protecting Americans from violence and injury threats. This information collection will enable the accurate, reliable, uniform, and timely submission to CDC of each recipient's work plan and progress reports, including strategy implementation, program evaluation and performance measures. It will also enable CDC to evaluate the program across all funded recipients.

CDC will use the information collected to look at the aggregate impact of program activities on program outcomes across all 10 recipients. The information collection will allow CDC to monitor the increased emphasis on strategies that affect health outcomes and impact, and is expected to reduce duplication of effort, enhance program impact and maximize the use of federal funds. CDC will be able to generate reports that summarize their activities and progress towards meeting work plan strategies and performance measure targets. In addition to CDC's tracking of program goals and outcomes, the data collected will provide a way for recipients to track their own activities and funding to local organizations as required by legislation. CDC will also have the capacity to generate reports that describe activities across multiple recipients and will be able to provide this information back to recipients or to respond to inquiries from HHS, the White House, Congress and other stakeholders about the national DELTA Impact Program activities and their impact.

The total estimated annualized time burden for this collection is 123 hours. The only cost to respondents will be time spent responding to the surveys.

Under the Paperwork Reduction Act of 1995 (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 (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-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 that summarizes the following proposed collection(s) of information for public comment:

1. Type of Information Collection Request: Reinstatement without change of a previously approved collection; Title of Information Collection: New Technology Payments for APCs Under the Outpatient Prospective Payment System; Use: CMS needs to keep pace with emerging new technologies and make them accessible to Medicare beneficiaries in a timely manner. It is necessary that we continue to collect appropriate information from interested parties such as hospitals, medical device manufacturers, pharmaceutical companies and others that bring to our attention specific services that they wish us to evaluate for New Technology APC payment. We are making no changes to the information that we collect. The information that we seek to continue to collect is necessary to determine whether certain new services are eligible for payment in New Technology APCs, to determine appropriate coding and to set an appropriate 4 payment rate for the new technology service. The intent of these provisions is to ensure timely beneficiary access to new and appropriate technologies. Form Number: CMS-10054 (OMB control number: 0938-0860); Frequency: Annually; Affected Public: Private Sector (Business or other For-profits); Number of Respondents: 10; Total Annual Responses: 10; Total Annual Hours: 160. (For policy questions regarding this collection contact Joshua McFeeters at 410-786-9732).

2. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Report of a Hospital Death Associated with Restraint or Seclusion; Use: The regulation that was published on May, 16, 2012 (77 FR 29074) included a reduction in the reporting requirement related to hospital deaths associated with the use of restraint or seclusion, § 482.13(g). Hospitals must use Form CMS-10455 to report those deaths associated with restraint and/or seclusion directly to the Centers for Medicare & Medicaid Services (CMS) Regional Office (RO). This requirement also applies to rehabilitation or psychiatric distinct part units (DPUs) in Critical Access Hospitals (CAHs). The RO must provide hospitals with instructions for submitting the form fax and/or email, based on RO preference. Hospitals are no longer required to report to CMS those deaths where there was no use of seclusion and the only restraint was 2-point soft wrist restraints beginning in May 9, 2014. This reporting requirement change resulted in no necessary edits to the form CMS-10455 as soft wrist restraints may be used in combination with other types of restraints. It was estimated that this would reduce the volume of reports that must be submitted by 90 percent for hospitals. In addition, the final rule replaced the previous requirement for reporting via telephone to CMS, which proved to be cumbersome for both CMS and hospitals, with a requirement that allows submission of reports via telephone, facsimile or electronically, as determined by CMS.

Form CMS-10455 is being revised in order to obtain the necessary information for the ROs to make a determination whether or not to authorize an on-site investigation related to the details surrounding the death of individuals associated with restraint and/or seclusion. Form Number: CMS-10455 (OMB control number: 0938-1210); Frequency: Occasionally; Affected Public: Private Sector; Number of Respondents: 6,389; Number of Responses: 6,389; Total Annual Hours: 2,619. (For policy questions regarding this collection contact Karina Meushaw at 410-786-1000.)

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).

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.

Type of Information Collection Request: Extension of a currently approved collection without change; Title of Information Collection: Hospice Quality Reporting Program; Use: The Hospice Item Set (HIS) is a standardized, patient-level data collection tool developed specifically for use by hospices. It is currently used for the collection of quality measure data pertaining to the Hospice Quality Reporting Program (HQRP). Since April 1, 2017, hospices have been using the HIS V2.00.0 which specifies the collection of data items that support eight National Quality Forum (NQF) endorsed Quality Measures (QMs) and an additional measure pair for hospice. All Medicare-certified hospice providers are required to submit HIS admission and discharge records to CMS for each patient admission and discharge. The HIS contains data elements that are used by the CMS to calculate these measures and also allows CMS to collect quality data from hospices in compliance with Section 3004 of the Affordable Care Act. Form Number: CMS-10390 (OMB control number: 0938-1153); Frequency: On Occasion; Affected Public: State, Local, or Tribal Governments, Private Sector (not-for-profit institutions); individuals or households; Number of Respondents: 4,259; Total Annual Responses: 4,259; Total Annual Hours: 686,630. For policy questions regarding this collection contact Cindy Massuda at (410) 786-0652.

I. Background

FDA is announcing the availability of a guidance for industry entitled “Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” In 2013, the Drug Quality and Security Act, created new section 503B of the FD&C Act (21 U.S.C. 353b), which describes a new category of compounders called outsourcing facilities. Section 503B of the FD&C Act describes the conditions that must be satisfied for human drug products compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility to qualify for exemptions from the following three sections of the FD&C Act:

• Section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning labeling of drugs with adequate directions for use);

• Section 505 (21 U.S.C. 355) (concerning the approval of drugs under new drug applications or abbreviated new drug applications); and

• Section 582 (21 U.S.C. 360eee-1) (concerning drug supply chain security requirements).

One of the conditions that must be met for a compounded drug product to qualify for the exemptions under section 503B of the FD&C Act is that the drug is not essentially a copy of one or more approved drugs (section 503B(a)(5)).

Section 503B(d)(2) defines essentially a copy of an approved drug as:

• A drug that is identical or nearly identical to an approved drug, or a marketed drug not subject to section 503(b) and not subject to approval in an application submitted under section 505, unless, in the case of an approved drug, the drug appears on the drug shortage list in effect under section 506E at the time of compounding, distribution, and dispensing (section 503B(d)(2)(A)) or

• a drug, a component of which is a bulk drug substance that is a component of an approved drug or a marketed drug that is not subject to section 503(b) and not subject to approval in an application submitted under section 505, unless there is a change that produces for an individual patient a clinical difference, as determined by the prescribing practitioner, between the compounded drug and the comparable approved drug (section 503B(d)(2)(B)).

This guidance sets forth FDA's policies concerning the “essentially a copy” provision of section 503B of the FD&C Act.

In the Federal Register of July 11, 2016 (81 FR 44879), FDA issued a notice announcing the availability of the draft version of this guidance. The comment period on the draft guidance ended on October 11, 2016. FDA received 29 comments on the draft guidance. In response to received comments or on its own initiative, FDA made several changes. For example, in response to requests in comments for direction on records retention, FDA added a recommendation that compounders maintain the records described in the guidance for at least 3 years. In addition, to address questions raised in comments, FDA clarified that the Agency does not intend to take action against an outsourcing facility for failing to compound in accordance with section 503B(a)(5) if it fills orders for a compounded drug that is essentially a copy of an approved drug that has been discontinued and is no longer marketed.

FDA received comments from hospital organizations regarding the potential implications of proposed policies for the preparation of compounded drugs used in in-patient settings. The final guidance notes that FDA is considering the applicability of the policies described in this guidance to hospitals and health systems. We recognize that this issue is of interest to many stakeholders and will publicly convey our further thinking on the applicability of these policies to hospitals and health systems with an opportunity for comment.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). This guidance represents the current thinking of FDA on “Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

This guidance contains collections of information that are subject to review by OMB under the PRA (44 U.S.C. 3501-3520). Under the PRA, Federal Agencies must obtain approval from OMB for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3 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 (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, in the Federal Register of July 11, 2016, we gave interested persons 60 days to comment on the information collection provisions in the draft guidance.

The information collection provisions in this guidance have been submitted to OMB for review as required by section 3507(d) of the PRA. These provisions are not in effect until they display a currently valid OMB control number. FDA will publish a notice in the Federal Register announcing OMB's decision regarding the information collection provisions in this guidance.

Persons with access to the internet may obtain the guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

I. Background

FDA is announcing the availability of a final guidance for industry entitled “Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application.” Certain licensed biological products may sometimes be mixed, diluted, or repackaged in a way not described in the approved labeling for the product to meet the needs of a specific patient. For example, for some biological products there is no licensed pediatric strength and/or dosage form. In addition, there may be certain circumstances when a person would remove a licensed biological product from its original container and place it into a different container(s) (repackage it), in a manner that is not within the scope of the approved labeling for the product. As described in the guidance, mixed, diluted, or repackaged biological products are not eligible for the statutory exemptions available to certain compounded drugs under sections 503A and 503B of the FD&C Act (21 U.S.C. 353a and 353b). In addition, a biological product that is mixed, diluted, or repackaged outside the scope of an approved BLA is considered an unlicensed biological product under section 351 of the Public Health Service (PHS) Act (42 U.S.C. 262).

This guidance describes the conditions under which FDA does not intend to take action for violations of section 351 of the PHS Act, and section 502(f)(1) (21 U.S.C. 352(f)(1)), section 582 (21 U.S.C. 360eee-1), and where specified, section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) of the FD&C Act, when a state-licensed pharmacy, a Federal facility, or an outsourcing facility dilutes, mixes, or repackages certain biological products outside the scope of an approved BLA.

In the Federal Register of January 13, 2017 (82 FR 4358), FDA issued a notice announcing the availability of the revised draft version of this guidance. The comment period on the draft guidance ended on March 14, 2017. FDA received 11 comments on the revised draft guidance. In response to received comments or on its own initiative, FDA made revisions to clarify certain points. For example, FDA added a footnote indicating that the Agency is considering the applicability of the policies described in this guidance to hospitals and health systems and intends to address these issues in separate guidance. FDA also clarified that one of the conditions under which the Agency does not intend to take action for the violations listed above is that any components used in mixing or diluting a licensed biological product are sterile, pharmaceutical grade, and otherwise appropriate for such use.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on mixing, diluting, or repackaging biological products outside the scope of an approved BLA. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

This guidance contains collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520). Under the PRA, Federal Agencies must obtain approval from OMB for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3 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 (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, in the Federal Register of January 13, 2017, we gave interested persons 60 days to comment on the information collection provisions in the draft guidance (82 FR 4358 at 4359).

The information collection provisions in this guidance will be submitted to OMB for review as required by section 3507(d) of the PRA. These provisions are not in effect until they display a currently valid OMB control number. FDA will publish a notice in the Federal Register announcing OMB's decision regarding the information collection provisions in this guidance.

The guidance also references registration and adverse event reporting for outsourcing facilities. The collections of information for outsourcing facility registration have been approved by OMB under OMB control number 0910-0777. The collections of information for adverse event reporting by outsourcing facilities have been approved by OMB under OMB control number 0910-0800.

Persons with access to the internet may obtain the guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or https://www.regulations.gov.

I. Background

FDA recognizes that the IEC is a global organization that prepares and publishes international standards for electrical, electronic, and related technologies, including laser products. This means that manufacturers distributing products in the United States and other countries might have to ensure conformance of their products with IEC standards as well as comply with FDA regulatory requirements. Complying with FDA regulations and conforming to the identified IEC standards may cause manufacturers to duplicate their efforts.

FDA acknowledges the advantages of a universal set of device-specific criteria and requirements. Moreover, FDA believes that under the circumstances described in this guidance, conformance with certain IEC standards would provide adequate protection of the public health and safety for laser products similar to FDA's performance standards in §§ 1040.10 and 1040.11 (21 CFR 1040.10 and 1040.11). FDA eventually intends to amend its standards for laser products at §§ 1040.10 and 1040.11 to harmonize many of its requirements with those of the IEC because FDA acknowledges the advantages of one set of criteria and requirements worldwide.

On June 24, 2007, FDA's Center for Devices and Radiological Health (CDRH) published a guidance entitled “Laser Products—Conformance with IEC 60825-1 and IEC 60601-2-22; Guidance for Industry and FDA Staff (Laser Notice No. 50)” (https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm094366.pdf). This draft guidance, when finalized, will not replace the recommendations provided in that 2007 guidance, and upon finalization of this guidance, manufacturers can follow either Laser Notice No. 50 or this guidance.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Laser Products—Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed.3.1 (Laser Notice No. 56)”. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the internet. A search capability for all CDRH guidance documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This guidance document is also available at https://www.regulations.gov. Persons unable to download an electronic copy of “Laser Products—Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed.3.1 (Laser Notice No. 56)” may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1500024 to identify the guidance you are requesting.

This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR 1002.10, 1010.2, 1010.3, 1040.10, and 1040.11 have been approved under OMB control number 0910-0025.

I. Background

FDA is announcing the availability of a final guidance for industry entitled “Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act.” Section 503A (21 U.S.C. 353a), added to the FD&C Act by the Food and Drug Administration Modernization Act of 1997, describes the conditions that must be satisfied for human drug products compounded by a licensed pharmacist in a State-licensed pharmacy or Federal facility, or by a licensed physician, to be exempt from the following three sections of the FD&C Act:

• Section 501(a)(2)(B) (21 U.S.C. 351 (a)(2)(B)) (concerning current good manufacturing practice requirements);

• Section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate directions for use); and

• Section 505 (21 U.S.C. 355) (concerning the approval of drugs under new drug applications (NDAs) or abbreviated new drug applications (ANDAs)).

One of the conditions that must be met for a compounded drug product to qualify for the exemptions under section 503A of the FD&C Act is that it must be compounded by a licensed pharmacist or a licensed physician that does not compound regularly or in inordinate amounts (as defined by the Secretary of Health and Human Services) any drug products that are essentially copies of a commercially available drug product (section 503A(b)(1)(D)).

The statute further states that the term “essentially a copy of a commercially available drug product” does not include a drug product in which there is a change, made for an identified individual patient, which produces for that patient a significant difference, as determined by the prescribing practitioner, between the compounded drug and the comparable commercially available drug product (section 503A(b)(2) of the FD&C Act).

This guidance sets forth FDA's policies concerning the “essentially a copy” provision under section 503A of the FD&C Act, including the terms “commercially available,” “essentially a copy of a commercially available drug product,” and “regularly or in inordinate amounts.”

In the Federal Register of July 11, 2016 (81 FR 44881), FDA issued a notice announcing the availability of the draft version of this guidance. The comment period on the draft guidance ended on October 11, 2016. FDA received approximately 88 comments on the draft guidance. In response to received comments or on its own initiative, FDA made several changes. For example, in response to requests in comments for direction on records retention, FDA added a recommendation that compounders maintain the records described in the guidance for a period of at least 3 years. In addition, to address questions raised in comments, FDA clarified that the policies in this guidance apply to a compounded drug product without regard to the source(s) of the active pharmaceutical ingredient (API) in that product, for example, the policies would apply regardless of whether the compounder used an API that was purchased as an isolate, or if the compounder modified a finished drug product containing an API.

FDA received comments on the draft guidance from hospital organizations regarding the potential implications of the proposed policies in the draft guidance for the preparation of compounded drugs used in in-patient settings. The final guidance notes that FDA is considering the applicability of the policies described in this guidance to hospitals and health systems. We recognize that this issue is of interest to many stakeholders and will convey our further thinking on the applicability of these policies to hospitals and health systems publicly with an opportunity for comment.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). This guidance represents the current thinking of FDA on “Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

This guidance contains collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520). Under the PRA, Federal Agencies must obtain approval from OMB for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3 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 (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, in the Federal Register of July 11, 2016, we gave interested persons 60 days to comment on the information collection provisions in the draft guidance (81 FR 44881).

The information collection provisions in this guidance have been submitted to OMB for review as required by section 3507(d) of the PRA. These provisions are not in effect until they display a currently valid OMB control number. FDA will publish a notice in the Federal Register announcing OMB's decision regarding the information collection provisions in this guidance.

Persons with access to the internet may obtain the guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

This information collection supports the above captioned Agency guidance document. In the Federal Register of July 11, 2016 (81 FR 44881), FDA announced the availability of a draft guidance for industry entitled “Guidance for Industry on Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act,” and included an analysis of the associated information collection.

Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353a) describes conditions that must be met in order for compounded drugs to receive exemptions from certain sections of the FD&C Act, including section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning current good manufacturing practice for drugs); section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate directions for use) and section 505 (21 U.S.C. 355) (concerning the approval of human drug products under new drug applications or abbreviated new drug applications).

One condition of section 503A is that a compounder “does not compound regularly or in inordinate amounts (as defined by the Secretary) any drug products that are essentially copies of a commercially available drug product” (section 503A(b)(1)(D)). However, for the purposes of this section, “essentially a copy of a commercially available drug product” does not include a drug product “in which there is a change, made for an identified individual patient, which produces for that patient a significant difference, as determined by the prescribing practitioner, between the compounded drug and the comparable commercially available drug product” (section 503A(b)(2)).

The draft guidance states that if a compounder intends to rely on such a determination to establish that a compounded drug is not essentially a copy of a commercially available drug product, the compounder should ensure that the determination is documented on a prescription. If a prescription does not make clear that the prescriber made the determination required by section 503A(b)(2), or a compounded drug is substituted for the commercially available product at the pharmacy, the compounder may contact the prescriber and if the prescriber confirms it, make a notation on the prescription that the compounded product contains a change that makes a significant difference for the patient. The notations should be as specific as those described in this document, and the date of the conversation with the prescriber should be included on the prescription.

In addition, if the drug was compounded because the approved product was not commercially available because it was on the FDA drug shortage list, the prescription or a notation on the prescription should note that it was on the drug shortage list and the date the list was checked.

Finally, compounders under section 503A should maintain records of the frequency in which they have compounded drug products that are essentially copies of commercially available drug products and the number of prescriptions that they have filled for compounded drug products that are essentially copies of commercially available drug products to document that such compounding has not been done “regularly” or in “inordinate amounts.”

FDA received 88 comments on the draft guidance, several of which raised issues pertaining to the information collection provisions in the draft guidance. The issues raised are addressed below.

Issue One: One commenter proposed that any compounded drug with the same Active Pharmaceutical Ingredient (API) as a commercially available drug product should be considered to be “essentially a copy” of the commercially available drug product.

FDA Response to Issue One: FDA has not made this proposed change. A compounded drug with the same API as a commercially available drug product may be very different from that commercially available drug product. For example, it may have a different route of administration and a substantially different strength. In such cases, a prescriber determination is not needed because the compounded drug would not be considered to be “essentially a copy” of the commercially available drug product, even if it had the same API.

Issue Two: Several individuals submitted comments requesting the collection of additional information than what was proposed in the draft guidance.

• One commenter requested that the medical record maintained by the prescriber should include additional scientific rationale for prescribing the compounded product.

• Another commenter requested documentation to justify the use of a bulk drug substance to compound a product that could have been made starting with FDA-approved products.

FDA Response to Issue Two: Regarding the first comment, this recommendation regarding what information a prescriber should maintain is outside the scope of this guidance. Regarding the second comment, the proposal is beyond the scope of the current guidance and we express no opinion on the proposed analysis and documentation.

Issue Three: Several individuals submitted comments regarding collection of the prescriber determination in the hospital setting.

• Some commenters noted the prescriber determination is not necessary in the hospital setting because pharmacists often determine when a compounded drug is needed for a patient and not the prescriber. For example, one commenter noted that hospitals may have standing policies that specify use of compounded drugs in certain scenarios.

• Other commenters suggested use of a template or “blanket” prescriber determination statement when certain drugs are needed for a patient population on a consistent basis.

• Another commenter noted that State scope of practice acts or hospital policy may prohibit pharmacists from writing in the patient chart or altering the electronic health record.

FDA Response to Issue Three: FDA is considering the applicability of the policies described in this guidance to hospitals and health systems and intends to address these issues in separate guidance.

Issue Four: Several individuals commented that it would be burdensome to document the prescriber determination, as well as to call a prescriber to document a prescriber determination when such determination is not evident on the original prescription. Individuals felt a prescriber determination should not be necessary in certain cases, such as when a prescription indicates a compounded drug.

FDA Response to Issue Four: Section 503A(b)(2) provides that a compounded drug is not essentially a copy of a commercially available drug product if there is a change, made for an identified individual patient, which produces for that patient a significant difference, as determined by the prescribing practitioner, between the compounded drug and the comparable commercially available drug. If a prescription already documents the prescriber's determination of significant difference, there is no additional documentation burden for the compounder. However, if a prescription does not make clear that the prescriber made the determination required by section 503A(d)(2), or a compounded drug is substituted for the commercially available product at the pharmacy, the compounder may contact the prescriber, and if the prescriber confirms it, make a notation on the prescription that the compounded product contains a change that makes a significant difference for the patient. FDA estimates this contact will take 3 minutes and should not present significant burden. Maintaining prescription records that may include such notations should not present any additional burden, as FDA understands that maintaining records of prescriptions for compounded drug products is part of the usual course of the practice of compounding and selling drugs and is required by States' pharmacy laws and other State laws governing recordkeeping by health care professionals and health care facilities. Finally, FDA notes that calling a prescriber to document a prescriber determination of significant difference is not a requirement. For example, the compounder has the option of not filling a prescription with a compounded drug if a prescriber determination is not provided.

Issue Five: One commenter stated that requiring a notation on the prescription that a compounded drug was on the drug shortage list when compounded, and the date the list was checked, would be overly burdensome.

FDA Response to Issue Five: FDA does not believe this presents a significant burden, as a compounder that wants to rely on a drug shortage to establish that a compounded drug is not essentially a copy of a commercially available drug would need to check FDA's shortage website. Noting the date the list was checked is not onerous, and is necessary for FDA to verify compliance during inspections. FDA estimates this activity would take 2 minutes.

Issue Six: One commenter requested clarity on how long records should be maintained; what specific information should be maintained; and when such records should be presented to FDA.

FDA Response to Issue Six: FDA has revised the guidance to include a recommended duration of 3 years for maintaining records. The guidance describes the records that can be retained to demonstrate compliance. FDA may request to review such records during establishment inspections.

FDA estimates the burden of this collection of information as follows:

We estimate that annually a total of approximately 6,888 compounders (“number of respondents” in table 1, line 1) will consult a prescriber to determine whether he or she has made a determination that the compounded drug has a change that produces a significant difference for a patient as compared to the comparable commercially available drug, and that the compounders will document this determination on approximately 172,200 prescription orders for compounded drugs (“total annual disclosures” in table 1, line 1). We estimate that the consultation between the compounder and the prescriber and adding a notation to each prescription that does not already document this determination will take approximately 3 minutes per prescription order.

In addition, we estimate that a total of approximately 6,888 compounders (“number of respondents” in table 1, line 2) will document this information on approximately 344,400 prescription orders for compounded drugs (“total annual disclosures” in table 1, line 2). We estimate that checking FDA's drug shortage list and documenting this information will take approximately 2 minutes per prescription order.

We estimate that a total of approximately 3,444 compounders (“number of recordkeepers” in table 2) will keep approximately 165,312 records (“total annual records”). We estimate that maintaining the records will take approximately 2 minutes per record.

Agenda: The committee will discuss supplemental new drug application (sNDA) 203214 supplement 18, XELJANZ (tofacitinib) tablets, submitted by Pfizer Inc., proposed for the treatment of adult patients with moderately to severely active ulcerative colitis who have demonstrated an inadequate response, loss of response, or intolerance to corticosteroids, azathioprine, 6-mercaptopurine, or tumor necrosis factor inhibitor therapy.

FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's website after the meeting. Background material is available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link.

Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before March 7, 2018. Oral presentations from the public will be scheduled between approximately 12:40 p.m. and 1:40 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before February 13, 2018. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by February 14, 2018.

Persons attending FDA's advisory committee meetings are advised that FDA is not responsible for providing access to electrical outlets.

For press inquiries, please contact the Office of Media Affairs at [email protected] or 301-796-4540.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Jay R. Fajiculay (See, FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the meeting.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

I. Background

FDA is announcing the availability of a draft guidance for industry entitled “Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products—Content and Format.”

On January 24, 2006, FDA published a final rule amending the requirements for the content and format of labeling for human prescription drug and biological products (71 FR 3922, January 24, 2006). This rule is known as the physician labeling rule because it addresses prescription drug labeling that is used by physicians and other health care providers. Under this rule, the prescribing information of new and more recently approved prescription drug and biological products contains the following three sections: Highlights, Full Prescribing Information: Contents, and Full Prescribing Information (§ 201.56(d)(1) (21 CFR 201.56(d)(1))).

Highlights is required to contain the drug names (proprietary name and nonproprietary name (established name of the drug or, for biological products, the proper name)), dosage form, route of administration, and, if applicable, controlled substance symbol of the drug or biological product (§ 201.57(a)(2) (21 CFR 201.57(a)(2))). This set of information is referred to as the “product title” and follows the Highlights Limitation Statement. Highlights also must include the year of initial U.S. approval of the drug or biological product (§ 201.57(a)(3)). The initial U.S. approval must be placed immediately beneath the product title and is the four-digit year in which FDA initially approved the new molecular entity, new biological product, or new combination of active ingredients.

This draft guidance provides recommendations on the content and format of the product title in Highlights. Recommended sources for product title terminology also are provided. Appendix A, “Dosage Form Terms for Use in Human Drug Product Labeling” and Appendix B, “Route of Administration Terms for Use in Human Drug Product Labeling” contain lists of recommended dosage form and route of administration terms, respectively, for use in the product title. This draft guidance contains recommendations for products with special nomenclature considerations, recommendations for what not to include in the product title, and implications for container and carton labeling.

The draft guidance also provides recommendations on the content and format of the initial U.S. approval in Highlights. Items to consider when determining the year of initial U.S. approval are included and drug products requiring special consideration are described.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on the content and format of the product title and initial U.S. approval in Highlights for human prescription drug and biological products. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

This draft guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in §§ 201.56 and 201.57 have been approved under OMB control number 0910-0572.

Persons with access to the internet may obtain the draft guidance at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov.

I. Background

FDA is announcing the availability of a draft guidance for industry entitled, “Material Threat Medical Countermeasure Priority Review Vouchers.” Section 3086 of the Cures Act adds new section 565A to the FD&C Act. Section 565A of the FD&C Act (21 U.S.C. 360bbb-4a) was designed to encourage development of medical countermeasures by offering additional incentives for obtaining approval of new drug or biological medical products for the prevention and treatment of harm from a biological, chemical, radiological, or nuclear agent identified as a material threat. Under section 565A of the FD&C Act, a sponsor of a human drug application for a material threat medical countermeasure application 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 (PHS) Act (42 U.S.C. 262). The draft guidance also provides information on using the priority review vouchers and on transferring priority review vouchers to other sponsors.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance represents the current thinking of FDA on obtaining a material threat medical countermeasure priority review voucher. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

Under the Paperwork Reduction Act of 1995 (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 that they conduct or sponsor. “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, 44 U.S.C. 3506(c)(2)(A), requires Federal agencies to provide a 60-day notice in the Federal Register for each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing this notice of the proposed collection of information set forth in this document.

With respect to the collection of information associated with this draft guidance, FDA invites comment on the following topics: (1) Whether the proposed information collected is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimated burden of the proposed information collected, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information collected; and (4) ways to minimize the burden of information collected on the respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Under the draft guidance, sponsors of certain medical countermeasure product applications submitted under section 505(b)(1) of the FD&C Act and section 351 of the PHS Act may request a priority review voucher. Based on inquiries FDA has received on section 565A and related discussions with sponsors, we estimate that we will receive annually approximately 2 requests from 2 sponsors, and that each request will take approximately 8 hours to prepare and submit to FDA.

The draft guidance also states that sponsors should notify FDA of their intent to use a priority review voucher, including the date on which the sponsor intends to submit the application, at least 90 days before use. We estimate that we will receive annually approximately 2 notifications of intent to use a voucher from 2 sponsors, and that each notification will take approximately 8 hours to prepare and submit to FDA. The draft guidance also permits the transfer of a priority review voucher from one sponsor to another, and states that each transfer should be documented with a letter of transfer. We estimate that we will receive approximately 1 letter indicating the transfer of a voucher from 1.5 application holders, and 1 letter acknowledging the receipt of a transferred voucher from 1.5 new voucher owners acknowledging the transfer, and that it will take approximately 8 hours to prepare and submit each letter to FDA.

FDA estimates the burden of this collection of information as follows:

Persons with access to the internet may obtain the draft guidance at https://www.fda.gov/RegulatoryInformation/Guidances/default.htm, https://www.regulations.gov, or https://www.fda.gov/medicalcountermeasures.

When submitting comments or requesting information, please include the information request collection title for reference, in compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995.

Information Collection Request Title: National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners—45 CFR part 60 Regulations and Forms, OMB No. 0915-0126—Revision.

Abstract: This is a request for a revision of OMB approval of the information collection contained in regulations found at 45 CFR part 60 governing the National Practitioner Data Bank (NPDB) and the forms to be used in registering with, reporting information to, and requesting information from the NPDB. Administrative forms are also included to aid in monitoring compliance with Federal reporting and querying requirements. Responsibility for NPDB implementation and operation resides in HRSA's Bureau of Health Workforce.

The intent of the NPDB is to improve the quality of health care by encouraging hospitals, State licensing boards, professional societies, and other entities providing health care services to identify and discipline those who engage in unprofessional behavior, and to restrict the ability of incompetent health care practitioners, providers, or suppliers to move from State to State without disclosure of previous damaging or incompetent performance. It also serves as a fraud and abuse clearinghouse for the reporting and disclosing of certain final adverse actions (excluding settlements in which no findings of liability have been made) taken against health care practitioners, providers, or suppliers by health plans, Federal agencies, and State agencies.

The reporting forms, request for information forms (query forms), and administrative forms (used to monitor compliance) are accessed, completed, and submitted to the NPDB electronically through the NPDB website at https://www.npdb.hrsa.gov/. All reporting and querying is performed through the secure portal of this website. This revision proposes changes to eliminate redundant and unnecessary forms, improve user error recovery, and improve overall data integrity. There is no change to the average burden per response. The total estimated number of respondents has increased from 5 million in 2015 to over 6 million in 2017, primarily attributable to increases in use of the “One-Time Query for an Individual” and “Continuous Query” forms. The increase in total respondents resulted in an estimated increase of approximately 47,000 total burden hours.

Need and Proposed Use of the Information: The NPDB acts primarily as a flagging system; its principal purpose is to facilitate comprehensive review of practitioners' professional credentials and background. Information is collected from, and disseminated to, eligible entities (entities that are entitled to query and/or report to the NPDB as authorized in Title 45 CFR part 60) on the following: (1) Medical malpractice payments, (2) licensure actions taken by Boards of Medical Examiners, (3) State licensure and certification actions, (4) Federal licensure and certification actions, (5) negative actions or findings taken by peer review organizations or private accreditation entities, (6) adverse actions taken against clinical privileges, (7) Federal or State criminal convictions related to the delivery of a health care item or service, (8) civil judgments related to the delivery of a health care item or service, (9) exclusions from participation in Federal or State health care programs, and (10) other adjudicated actions or decisions. It is intended that NPDB information should be considered with other relevant information in evaluating credentials of health care practitioners, providers, and suppliers.

Likely Respondents: Eligible entities or individuals that are entitled to query and/or report to the NPDB as authorized in regulations found at 45 CFR part 60.

Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose, or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install, and utilize technology and systems for the purpose of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below.

HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment was established under Section 222 of the Public Health Service (PHS) Act, [42 U.S.C. Section 217a], as amended.

The purpose of the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment is to advise the Secretary, HHS; the Director, CDC; and the Administrator, HRSA regarding objectives, strategies, policies, and priorities for HIV, viral hepatitis, and other STDs; prevention and treatment efforts including surveillance of HIV infection, AIDS, viral hepatitis, and other STDs, and related behaviors; epidemiologic, behavioral, health services, and laboratory research on HIV, viral hepatitis, and other STDs; identification of policy issues related to HIV/viral hepatitis/STD professional eduction, patient healthcare delivery, and prevention services; Agency policies about prevention of HIV, viral hepatitis and other STDs; treatment, healthcare delivery, and research and training; strategic issues influencing the ability of CDC and HRSA to fulfill their missions of providing prevention and treatment services; programmatic efforts to prevent and treat HIV, viral hepatitis, and other STDs; and support to the Agencies in their developoment of responses to emerging health needs related to HIV, viral hepatitis, and other STDs. Information about the Committee and the meeting agenda is available by contacting CDR Holly Berilla at the contact information above.

During the meeting, the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment will discuss workgroup reports and updates, information regarding the National Ryan White HIV/AIDS Program Conference, and Committee business-related items. Agenda items are subject to change as priorities dictate.

Due to the nature and time limitations of the meeting, members of the public will not have an opportunity to provide oral comments, although written comments may be submitted to CDR Holly Berilla at the contact information listed above at least 10 days prior to the meeting. Individuals who need special assistance should notify CDR Holly Berilla at the contact information listed above at least 10 days prior to the meeting.

In accordance with Executive Order 13798 Promoting Free Speech and Religious Liberty (May 4, 2017), 82 FR 21675, and the Attorney General's Guidance on Federal Law Protections for Religious Liberty (October 6, 2017), Part A, Office of the Secretary, Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services (HHS), as last amended at 81 FR 95622 (December 28, 2016), is being amended at Chapter AT, Office for Civil Rights (OCR) to reflect the restructuring of OCR as follows:

The Coast Guard requires marine employers to establish random drug testing programs for covered crewmembers on inspected and uninspected vessels in accordance with 46 CFR 16.230. Every marine employer is required by 46 CFR 16.500 to collect and maintain a record of drug testing program data for each calendar year, and submit this data by 15 March of the following year to the Coast Guard in an annual MIS report.

Each year, the Coast Guard will publish a notice reporting the results of random drug testing for the previous calendar year's MIS data and the minimum annual percentage rate for random drug testing for the next calendar year. The purpose of setting a minimum random drug testing rate is to assist the Coast Guard in analyzing its current approach for deterring and detecting illegal drug abuse in the maritime industry.

The Coast Guard announces that the minimum random drug testing rate for calendar year 2018 is 25 percent. The Coast Guard may increase this rate if MIS data indicates a qualitative deficiency of reported data or the positive random testing rate is greater than 1.0 percent in accordance with 46 CFR part 16.230(f)(2). MIS data for the most recent reporting year indicates that the positive rate is less than one percent.

For 2018, the minimum random drug testing rate will continue at 25 percent of covered employees for the period of January 1, 2018 through December 31, 2018 in accordance with 46 CFR 16.230(e).

CBP invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). This process is conducted in accordance with 5 CFR 1320.8. Written comments and suggestions from the public and affected agencies should address one or more of the following four points: (1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) suggestions to enhance the quality, utility, and clarity of the information to be collected; and (4) suggestions to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. The comments that are submitted will be summarized and included in the request for approval. All comments will become a matter of public record.

Title: Drawback Process Regulations.

OMB Number: 1651-0075.

Form Number: CBP Forms 7551, 7552 and 7553.

Current Actions: This submission is being made to extend the expiration date of this information collection with a decrease to the burden hours due to updated agency estimates. There is no change CBP Forms 7551, 7552, 7553, or to the information being collected.

Type of Review: Extension (without change).

Abstract: The collections of information related to the drawback process are required to implement the provisions of 19 CFR part 191, and certain provisions of part 181 (regarding NAFTA drawback claims), which provide for refunds of duties, as well as taxes and fees in certain situations, imposed merchandise where there is a subsequent related exportation or destruction. The claims referred to in this notice are limited to drawback claims filed in compliance with the regulations in parts 181 and 191 and under 19 U.S.C. 1313, as it was in effect prior to the amendments made by the Trade Facilitation and Trade Enforcement Act of 2015 (TFTEA) (Pub. L. 114-125, 130 stat. 122, February 24, 2016). If the requirements set forth in Parts 181 and 191 are met, claimants may file for a refund using CBP Form 7551, Drawback Entry. CBP Form 7552, Delivery Certificate for Purposes of Drawback, is used to record transfers of merchandise and is also used each time a change to the merchandise occurs as a result of a manufacturing operation. CBP Form 7553, Notice of Intent to Export, Destroy or Return Merchandise for Purposes of Drawback, is used to notify CBP if an exportation, destruction, or return of the imported merchandise will take place. The information collected on these forms is authorized by 19 U.S.C. 1313(l). The drawback forms are accessible at http://www.cbp.gov/newsroom/publications/forms.