January 2016 – Federal Register Recent Federal Regulation Documents

We, the U.S. Fish and Wildlife Service (Service or USFWS), have received an application from the Massachusetts Division of Fisheries and Wildlife (MADFW) for an incidental take permit (ITP) under the Endangered Species Act of 1973, as amended (ESA). We are considering issuing a 25-year permit to the applicant that would authorize take of the federally threatened piping plover incidental to otherwise lawful activities, specifically recreational activities and beach operations on piping plover breeding beaches in Massachusetts. Pursuant to the ESA and the National Environmental Policy Act (NEPA), we announce the availability of the MADFW's ITP application and draft habitat conservation plan (HCP), as well as the Service's draft environmental assessment (EA), for public review and comment. We provide this notice to seek comments from the public and Federal, Tribal, State, and local governments.

The Legal Services Corporation (LSC) issues this Notice describing the conditions under which Letters of Intent to Apply for 2016 funding will be received for the Pro Bono Innovation Fund. On December 18, 2015, Congress provided $4 million for the Pro Bono Innovation Fund through the Consolidated Appropriations Act for 2016.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

On October 26, 2015, the Coast Guard published a direct final rule, which notified the public of our intent to amend merchant mariner manning regulations to align them with statutory changes made by the Howard Coble Coast Guard and Maritime Transportation Act of 2014. The Act allows oilers serving on certain offshore support vessels, towing vessels, and barges to be divided into at least two watches. The change would increase the sea service credit affected mariners are permitted to earn for each 12-hour period of work from one day to one and a half days. The rule will go into effect as scheduled.

The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.

We, the U.S. Fish and Wildlife Service, invite the public to comment on the following application to conduct certain activities with endangered species. With some exceptions, the Endangered Species Act (ESA) prohibits activities with listed species unless Federal authorization is acquired that allows such activities.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.'' This guidance updates and clarifies the information regarding sterilization processes that FDA recommends sponsors include in 510(k)s for devices labeled as sterile. This guidance document also provides details about the pyrogenicity information that FDA recommends sponsors include in a 510(k) submission.

Notice is hereby given that the U.S. International Trade Commission has determined to review in part the presiding administrative law judge's (``ALJ'') final initial determination (``final ID'') issued on October 27, 2015 finding a violation of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337 (``section 337'') in the above-captioned investigation.

The Commission is noticing a recent Postal Service filing concerning a modification to a Global Reseller Expedited Package Services 4 negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.

NASA is making technical amendments to the NASA FAR Supplement (NFS) to provide needed editorial changes.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute on Minority Health and Health Disparities (NIMHD), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function 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) 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 the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Nathan Stinson, Jr., Ph.D., MD, MPH, Director, Division of Extramural Scientific Programs, National Institute on Minority Health and Health Disparities, National Institutes of Health, 6707 Democracy Blvd., Suite 800, Bethesda, MD 20892-5465, or call non-toll free number (301-594-8704 or email your request including your address to: stinsonn@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received March 21, 2016. Proposed Collection: National Institute on Minority Health and Health Disparities Research Endowments0925NEWExisting Collection In Use without an OMB Number- National Institute on Minority Health and Health Disparities (NIMHD), National Institutes of Health (NIH). Need and Use of Information Collection: The NIMHD Research Endowment Program builds research capacity and research infrastructure in order to facilitate minority health research and research regarding other health disparity populations at eligible institutions under sections 736 and 464z-4 of the Public Health Service Act (PHS Act). NIH regulations contains requirements that are subject to OMB approval under the Paperwork Reduction Act of 1995, as amended (44 U.S.C. chapter 35). Title 45 of the CFR, sections 52i.3(b)(2), 52i.4(a), 52i.4(c), 52i.5(a), 52i.9(b), 52i.11(b), and 52i.11(d) contain reporting and information collection requirements that are subject to OMB approval under the Paperwork Reduction Act. Title 45 of the CFR, sections 52i.10, 52i.11(a)(1), 52i.11(a)(2), 52i.11(a)(3), 52i.11(a)(4), and 52i.11(b) contain recordkeeping requirements that are subject to OMB review under the Paperwork Reduction Act. The respondents for this notice consist of institutions currently funded under Section 736 or Section 464z-4 of the PHS Act. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 548.

The US African Development Foundation (USADF) will hold its quarterly meeting of the Board of Directors to discuss the agency's programs and administration.

In compliance with the Paperwork Reduction Act of 1995, the Army Family Advocacy Program Office, US Army announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.

The National Park Service is soliciting comments on the significance of properties nominated before January 2, 2016, for listing or related actions in the National Register of Historic Places.