December 29, 2015 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is establishing a public docket to receive input on clinical trial designs in emerging infectious diseases. Interested parties are invited to submit comments, supported by research and data, regarding clinical trial designs.

The National Science Foundation (NSF) has submitted the following information collection requirement to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. This is the second notice for public comment; the first was published in the Federal Register at 80 FR 64024, and one comment was received. NSF is forwarding the proposed renewal submission to the Office of Management and Budget (OMB) for clearance simultaneously with the publication of this second notice. The full submission may be found at: https://www.reginfo.gov/public/do/PRAMain. Comments regarding (a) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility and clarity of the information to be collected; or (d) ways 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 should be addressed to: Office of Information and Regulatory Affairs of OMB, Attention: Desk Officer for National Science Foundation, 72517th Street, NW. Room 10235, Washington, DC 20503, and to Suzanne H. Plimpton, Reports Clearance Officer, National Science Foundation, 4201 Wilson Boulevard, Suite 1265, Arlington, Virginia 22230 or send email to splimpto@nsf.gov. Comments regarding these information collections are best assured of having their full effect if received within 30 days of this notification. Copies of the submission(s) may be obtained by calling 703-292-7556.

In accordance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which provides opportunity for public comment on new or revised data collections, the Railroad Retirement Board (RRB) will publish periodic summaries of proposed data collections. Comments are invited on: (a) Whether the proposed information collection is necessary for the proper performance of the functions of the agency, including whether the information has practical utility; (b) the accuracy of the RRB's estimate of the burden of the collection of the information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden related to the collection of information on respondents, including the use of automated collection techniques or other forms of information technology. 1. Title and purpose of information collection: Employer Reporting; 3220-0005. Under Section 9 of the Railroad Retirement Act (RRA), and Section 6 of the Railroad Unemployment Insurance Act (RUIA), railroad employers are required to submit reports of employee service and compensation to the RRB as needed for administering the RRA and RUIA. To pay benefits due on a deceased employee's earnings records or determine entitlement to, and amount of annuity applied for, it is necessary at times to obtain from railroad employers current (lag) service and compensation not yet reported to the RRB through the annual reporting process. The reporting requirements are specified in 20 CFR 209.6 and 209.7. The RRB currently utilizes Form G-88A.1, Notice of Retirement and Verification of Date Last Worked, Form G-88A.2, Notice of Retirement and Request for Service Needed for Eligibility, and Form AA-12, Notice of Death and Compensation, to obtain the required lag service and related information from railroad employers. Form G-88A.1 is sent by the RRB via a computer-generated listing or transmitted electronically via the RRB's Employer Reporting System (ERS) to employers. ERS consists of a series of screens with completion instructions and collects essentially the same information as the approved manual version. Form G-88A.1 is used for the specific purpose of verifying information previously provided to the RRB regarding the date last worked by an employee. If the information is correct, the employer need not reply. If the information is incorrect, the employer is asked to provide corrected information. Form G-88A.2 is used by the RRB to secure lag service and compensation information when it is needed to determine benefit eligibility. Form AA-12 obtains a report of lag service and compensation from the last railroad employer of a deceased employee. This report covers the lag period between the date of the latest record of employment processed by the RRB and the date an employee last worked, the date of death or the date the employee may have been entitled to benefits under the Social Security Act. The information is used by the RRB to determine benefits due on the deceased employee's earnings record. The RRB proposes no changes to Forms G-88A.1, G-88A.2 or AA-12. In addition, 20 CFR 209.12(b) requires all railroad employers to furnish the RRB with the home addresses of all employees hired within the last year (new-hires). Form BA-6a, Form BA-6 Address Report, is used by the RRB to obtain home address information of employees from railroad employers who do not have the home address information computerized and who submit the information in a paper format. The form also serves as an instruction sheet to railroad employers who submit the information electronically by magnetic tape, cartridge, or CD ROM. The RRB proposes no changes to Form BA-6a. Completion of the forms is mandatory. Multiple responses may be filed by respondent.

The Export-Import Bank of the United States (Ex-Im Bank), as a part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal Agencies to comment on the proposed information collection, as required by the Paperwork Reduction Act of 1995. This collection of information is necessary, pursuant to 12 U.S.C. Sec. 635 (a) (1), to determine whether or not a company has a good payment history. This form will enable Ex-Im Bank to make a credit decision on a foreign buyer credit limit request submitted by a new or existing policy holder. Additionally, this form is used by those Ex-Im Bank policy holders granted delegated authority to commit the Bank to a foreign buyer credit limit. The form can be viewed at https://www.exim.gov/sites/default/files/ pub/pending/eib99-14.pdf.

The New England Fishery Management Council (Council) is scheduling a public meeting of its Herring Committee to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.

In accordance with the Paperwork Reduction Act of 1995 and its implementing regulations, the Federal Railroad Administration (FRA) hereby announces that it is seeking renewal of the following currently approved information collection activities. Before submitting these information collection requests (ICRs) for clearance by the Office of Management and Budget (OMB), FRA is soliciting public comment on specific aspects of the activities identified below.

The Commission is noticing a recent Postal Service filing concerning the addition of Priority Mail Contract 171 to the competitive product list. This notice informs the public of the filing, invites public comment, and takes other administrative steps.

FMCSA announces receipt of applications from 55 individuals for exemption from the prohibition against persons with insulin-treated diabetes mellitus (ITDM) operating commercial motor vehicles (CMVs) in interstate commerce. If granted, the exemptions would enable these individuals with ITDM to operate CMVs in interstate commerce.

The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently the Bureau of the Fiscal Service within the Department of the Treasury is soliciting comments concerning the Regulations Governing U.S. Treasury SecuritiesState and Local Government Series.

The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently the Bureau of the Fiscal Service within the Department of the Treasury is soliciting comments concerning the Request by Owner or Person Entitled to Payment or Reissue of United States Savings Bonds/Notes Deposited in Safekeeping When Original Custody Receipts Are Not Available.

The Administration for Children and Families (ACF), Office of Child Support Enforcement, Division of Program Innovation announces the award of a cooperative agreement in the amount of $700,000 to the Wisconsin Department for Children and Families in Madison, WI to support the evaluation of the Child Support Noncustodial Parent Employment Demonstration. In FY 2012, the Office of Child Support Enforcement (OCSE) competitively awarded a cooperative agreement to the Wisconsin Department of Children and Families to conduct a 5-year evaluation of OCSE's national demonstration called Child Support Noncustodial Parent Employment Demonstration (CSPED) under Funding Opportunity Announcement (FOA) number HHS-2012-ACF-OCSE-FD-0537. Under this FOA, a total of $4.5 million of 1115 funds were made available to the Wisconsin Department of Children and Families to conduct this evaluation. The award of $700,000 the Wisconsin Department of Children and Families is required to cover the unanticipated costs of conducting the CSPED evaluation. The CSPED evaluation includes an impact evaluation using random assignment, an implementation study and a benefit-cost analysis. The evaluator is also providing evaluation-related technical assistance to the grantees implementing CSPED. A baseline and 12 month follow-up survey are being conducted. Administrative data from multiple sources are also being collected and evaluated. A grants management information system was developed for grantees to use to conduct random assignment, enroll individuals into the project, and document service delivery.

The Department of Veterans Affairs (VA) is amending its regulations concerning the payment of fees for representation by agents and attorneys in proceedings before VA. Specifically, this rule removes the requirement that an agent or attorney file a direct-pay fee agreement with both the VA Office of the General Counsel and the agency of original jurisdiction. The intended effect of this final rule is to require that direct-pay fee agreements be submitted only to the agency of original jurisdiction, thereby eliminating duplicate filings by agents and attorneys.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection contained in FDA's regulations on current good manufacturing practice (CGMP) for positron emission tomography (PET) drugs.

The Environmental Protection Agency has submitted an information collection request (ICR), ``NESHAP for Secondary Aluminum Production (40 CFR part 63, subpart RRR) (Renewal)'' (EPA ICR No. 1894.08, OMB Control No. 2060-0433) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). This is a proposed extension of the ICR, which is currently approved through December 31, 2015. Public comments were previously requested via the Federal Register (80 FR 32116) on June 5, 2015 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

The United States Copyright Office is undertaking a public study to assess the operation of section 1201 of Title 17, including the triennial rulemaking process established under the DMCA to adopt exemptions to the prohibition against circumvention of technological measures that control access to copyrighted works. To aid this effort, and to ensure thorough assistance to Congress, the Office is seeking public input on a number of key questions.

In accordance with the Federal Advisory Committee Act (5 U.S.C. Appendix 1-16), notice is hereby given of the 2016 meeting schedule of the Gateway National Recreation Area Fort Hancock 21st Century Federal Advisory Committee. Agenda: The Committee will offer expertise and advice regarding the preservation of historic Army buildings at Fort Hancock and Sandy Hook Proving Ground National Historic Landmark into a viable, vibrant community with a variety of uses for visitors, not-for-profit organizations, residents and others. All meetings will begin at 9:00 a.m., with a public comment period at 11:30 a.m. (EASTERN). All meetings are open to the public.

The Department of Defense is publishing this notice to announce that it is renewing the charter for the Secretary of the Navy Advisory Panel (``the Panel'').

In compliance with the Paperwork Reduction Act of 1995, the Land Buy-Back Program for Tribal Nations (Buy-Back Program), Office of the Secretary, Department of the Interior announces the proposed extension of a public information collection and seeks public comments on the provisions thereof.