April 20, 2016 – Federal Register Recent Federal Regulation Documents

Reader Aids
Document Number: FR-2016-04-20-ReaderAids
Type: Reader Aids
Date: 2016-04-20
National Park Week, 2016
Document Number: 2016-09342
Type: Proclamation
Date: 2016-04-20
Agency: Executive Office of the President
Establishment of the Lewis-Clark Valley Viticultural Area and Realignment of the Columbia Valley Viticultural Area
Document Number: 2016-09264
Type: Rule
Date: 2016-04-20
Agency: Alcohol and Tobacco Tax and Trade Bureau, Department of Treasury, Department of the Treasury
The Alcohol and Tobacco Tax and Trade Bureau (TTB) establishes the approximately 306,650-acre Lewis-Clark Valley viticultural area in portions of Nez Perce, Lewis, Clearwater, and Latah Counties in Idaho and Asotin, Garfield, and Whitman Counties in Washington. TTB is also modifying the boundary of the existing Columbia Valley viticultural area to eliminate a partial overlap with the Lewis-Clark Valley viticultural area. The boundary modification will decrease the size of the approximately 11,370,320-acre Columbia Valley viticultural area by approximately 57,020 acres. The Lewis-Clark Valley viticultural area is not located within and does not overlap any other viticultural area. TTB designates viticultural areas to allow vintners to better describe the origin of their wines and to allow consumers to better identify wines they may purchase.
Sunshine Act Meeting Notice
Document Number: 2016-09256
Type: Notice
Date: 2016-04-20
Agency: Department of Energy, Federal Energy Regulatory Commission
Government in the Sunshine Act Meeting Notice
Document Number: 2016-09232
Type: Notice
Date: 2016-04-20
Agency: International Trade Commission, Agencies and Commissions
Sunshine Act Meeting
Document Number: 2016-09210
Type: Notice
Date: 2016-04-20
Agency: Securities and Exchange Commission, Agencies and Commissions
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-09209
Type: Notice
Date: 2016-04-20
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-09195
Type: Notice
Date: 2016-04-20
Agency: Department of Health and Human Services, National Institutes of Health
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-09190
Type: Notice
Date: 2016-04-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Eligibility of the Republic of Poland To Export Poultry Products to the United States
Document Number: 2016-09185
Type: Proposed Rule
Date: 2016-04-20
Agency: Department of Agriculture, Food Safety and Inspection Service
The Food Safety and Inspection Service (FSIS) is proposing to add the Republic of Poland (Poland) to the list of countries in the regulations eligible to export poultry products to the United States. FSIS has reviewed Poland's poultry laws, regulations, and inspection system as implemented and has tentatively determined that they are equivalent to the Poultry Products Inspection Act (PPIA), the regulations implementing this statute, and the U.S. food safety system for poultry. Should this rule become final, slaughtered poultry, or parts or other products thereof, processed in certified Polish establishments, would be eligible for export to the United States. Although Poland may be listed in FSIS's regulations as eligible to export poultry products to the United States, the products must also comply with all other applicable requirements of the United States, including those of USDA's Animal and Plant Health Inspection Service (APHIS), before any products can enter the United States. All such products would be subject to re- inspection at U.S. ports-of-entry by FSIS inspectors.
Mississippi; Amendment No. 1 to Notice of a Major Disaster Declaration
Document Number: 2016-09180
Type: Notice
Date: 2016-04-20
Agency: Federal Emergency Management Agency, Department of Homeland Security
This notice amends the notice of a major disaster declaration for the State of Mississippi (FEMA-4268-DR), dated March 25, 2016, and related determinations.
Texas; Amendment No. 2 to Notice of a Major Disaster Declaration
Document Number: 2016-09179
Type: Notice
Date: 2016-04-20
Agency: Federal Emergency Management Agency, Department of Homeland Security
This notice amends the notice of a major disaster declaration for the State of Texas (FEMA-4266-DR), dated March 19, 2016, and related determinations.
District of Columbia; Amendment No. 1 to Notice of a Major Disaster Declaration
Document Number: 2016-09178
Type: Notice
Date: 2016-04-20
Agency: Federal Emergency Management Agency, Department of Homeland Security
This notice amends the notice of a major disaster declaration for the District of Columbia (FEMA-4260-DR), dated March 4, 2016, and related determinations.
Louisiana; Amendment No. 4 to Notice of a Major Disaster Declaration
Document Number: 2016-09177
Type: Notice
Date: 2016-04-20
Agency: Federal Emergency Management Agency, Department of Homeland Security
This notice amends the notice of a major disaster declaration for the State of Louisiana (FEMA-4263-DR), dated March 13, 2016, and related determinations.
Proposed Collection; Comment Request
Document Number: 2016-09176
Type: Notice
Date: 2016-04-20
Agency: Department of Defense, Office of the Secretary
In compliance with the Paperwork Reduction Act of 1995, the Office of the Under Secretary of Defense for Acquisition, Technology and Logistics 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.
Section 512 Study: Notice of Location Change for New York Public Roundtables
Document Number: 2016-09175
Type: Notice
Date: 2016-04-20
Agency: Library of Congress, Agencies and Commissions
The United States Copyright Office has changed the location of the May 2 and 3, 2016 public roundtables on the section 512 study. The public roundtables in New York and California were originally announced in the Office's Notice of Inquiry on March 18, 2016. See 81 FR 14896. The May 2 and 3, 2016 public roundtables in New York will now be held in Room 506 of the Thurgood Marshall United States Courthouse, 40 Centre Street, New York, New York, 10007.
Mississippi; Amendment No. 2 to Notice of a Major Disaster Declaration
Document Number: 2016-09174
Type: Notice
Date: 2016-04-20
Agency: Federal Emergency Management Agency, Department of Homeland Security
This notice amends the notice of a major disaster declaration for the State of Mississippi (FEMA-4268-DR), dated March 25, 2016, and related determinations.
Texas; Amendment No. 3 to Notice of a Major Disaster Declaration
Document Number: 2016-09173
Type: Notice
Date: 2016-04-20
Agency: Federal Emergency Management Agency, Department of Homeland Security
This notice amends the notice of a major disaster declaration for the State of Texas (FEMA-4266-DR), dated March 19, 2016, and related determinations.
National Vaccine Injury Compensation Program; List of Petitions Received
Document Number: 2016-09172
Type: Notice
Date: 2016-04-20
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Anchorage Regulations; Special Anchorage Areas, Marina del Rey Harbor, California
Document Number: 2016-09171
Type: Proposed Rule
Date: 2016-04-20
Agency: Coast Guard, Department of Homeland Security
The Coast Guard announces a public meeting to receive comments on a supplemental notice of proposed rulemaking (NPRM) to revise the special anchorage in Marina del Rey Harbor, California. Based on the comments received in response to the NPRM that was published in the Federal Register on May 28, 2014, we published a supplemental NPRM proposing to amend the shape and reduce the size of the special anchorage in Marina del Rey Harbor, California. Additionally, we propose to clarify the language in the note section of the existing regulation.
Request for Public Comment: 60 Day Information Collection: Indian Health Service Medical Staff Credentials and Privileges Files
Document Number: 2016-09170
Type: Notice
Date: 2016-04-20
Agency: Department of Health and Human Services, Indian Health Service
In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to comment on the information collection titled, ``Indian Health Service Medical Staff Credentials and Privileges Files,'' OMB Control Number 0917-0009, which expires August 31, 2016.
Technical Mapping Advisory Council
Document Number: 2016-09169
Type: Notice
Date: 2016-04-20
Agency: Federal Emergency Management Agency, Department of Homeland Security
The Federal Emergency Management Agency (FEMA) Technical Mapping Advisory Council (TMAC) will meet in person on May 9-10, 2016 in Reston, VA. The meeting will be open to the public.
Magnuson-Stevens Act Provisions; General Provisions for Domestic Fisheries; Application for Exempted Fishing Permits
Document Number: 2016-09168
Type: Notice
Date: 2016-04-20
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The Assistant Regional Administrator for Sustainable Fisheries, Greater Atlantic Region, NMFS, has made a preliminary determination that an Exempted Fishing Permit application contains all of the required information and warrants further consideration. This Exempted Fishing Permit would allow eight commercial fishing vessels to fish outside of the limited access sea scallop regulations in support of bycatch reduction research by using a bi-directional extended link apron. Regulations under the Magnuson-Stevens Fishery Conservation and Management Act require publication of this notification to provide interested parties the opportunity to comment on applications for proposed Exempted Fishing Permits.
Final Revised Vaccine Information Materials for 9-valent HPV (Human Papillomavirus) Vaccine
Document Number: 2016-09167
Type: Notice
Date: 2016-04-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Under the National Childhood Vaccine Injury Act (NCVIA)(42 U.S.C. 300aa-26), CDC must develop vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. On October 22, 2015, CDC published a notice in the Federal Register (80 FR 64002) seeking public comments on proposed updated vaccine information materials for 9-valent HPV (Human Papillomavirus) Gardasil[supreg]-9 vaccine. Following review of comments submitted and consultation as required under the law, CDC has finalized the materials. Copies of the final vaccine information materials for 9-valent HPV Gardasil[supreg]-9 vaccine are available to download from http://www.cdc.gov/vaccines/hcp/vis/index.html or http:// www.regulations.gov (see Docket Number CDC-2015-0089).
Final Revised Vaccine Information Materials for Meningococcal ACWY Vaccines
Document Number: 2016-09166
Type: Notice
Date: 2016-04-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. 300aa-26), CDC must develop vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. On October 14, 2015, CDC published a notice in the Federal Register (80 FR 61819) seeking public comments on proposed updated vaccine information materials for Meningococcal ACWY and Serogroup B Meningococcal vaccines. Following review of comments submitted and consultation as required under the law, CDC has finalized the materials for Meningococcal ACWY vaccines. Copies of the final vaccine information materials for Meningococcal ACWY vaccines are available to download from http://www.cdc.gov/ vaccines/hcp/vis/index.html or http://www.regulations.gov (see Docket Number CDC-2015-0059). CDC will publish the final vaccine information materials for Serogroup B Meningococcal vaccines when they are completed.
Certain New Pneumatic Off-the-Road Tires From the People's Republic of China: Final Results of Antidumping Duty Administrative Review; 2013-2014
Document Number: 2016-09165
Type: Notice
Date: 2016-04-20
Agency: Department of Commerce, International Trade Administration
On October 9, 2015, the Department of Commerce (``Department'') published the preliminary results of the administrative review of the antidumping duty order on certain new pneumatic off-the-road tires (``OTR tires'') from the People's Republic of China (``PRC'').\1\ The period of review (``POR'') is September 1, 2013, through August 31, 2014. Based on our analysis of the comments received, we made certain changes in the margin calculations. The final dumping margins for this review are listed in the ``Final Results'' section below.
Meeting of the Community Preventive Services Task Force
Document Number: 2016-09164
Type: Notice
Date: 2016-04-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) announces the next meeting of the Community Preventive Services Task Force (Task Force). The Task Force is an independent, nonpartisan, nonfederal, and unpaid panel. Its members represent a broad range of research, practice, and policy expertise in prevention, wellness, health promotion, and public health, and are appointed by the CDC Director. The Task Force was convened in 1996 by the Department of Health and Human Services (HHS) to identify community preventive programs, services, and policies that increase healthy longevity, save lives and dollars and improve Americans' quality of life. CDC is mandated to provide ongoing administrative, research, and technical support for the operations of the Task Force. During its meetings, the Task Force considers the findings of systematic reviews on existing research and issues recommendations. Task Force recommendations are not mandates for compliance or spending. Instead, they provide information about evidence-based options that decision makers and stakeholders can consider when determining what best meets the specific needs, preferences, available resources, and constraints of their jurisdictions and constituents. The Task Force's recommendations, along with the systematic reviews of the scientific evidence on which they are based, are compiled in the Guide to Community Preventive Services (Community Guide).
Secretary of State's Determination Under the International Religious Freedom Act of 1998
Document Number: 2016-09163
Type: Notice
Date: 2016-04-20
Agency: Department of State
The Secretary of State's designation of ``countries of particular concern'' for religious freedom violations. Pursuant to Section 408(a) of the International Religious Freedom Act of 1998 (Pub. L. 105-292), as amended (the Act), notice is hereby given that, on February 29, 2016, the Secretary of State, under authority delegated by the President, has designated each of the following as a ``country of particular concern'' (CPC) under sec. 402(b) of the Act, for having engaged in or tolerated particularly severe violations of religious freedom: Burma, China, Eritrea, Iran, the Democratic People's Republic of Korea, Saudi Arabia, Sudan, Tajikistan, Turkmenistan, and Uzbekistan. The Secretary simultaneously designated the following Presidential Actions for these CPCs: For Burma, the existing ongoing arms embargo referenced in 22 CFR 126.1(a), pursuant to sec. 402(c)(5) of the Act; For China, the existing ongoing restriction on exports to China of crime control and detection instruments and equipment, under the Foreign Relations Authorization Act of 1990 and 1991 (Pub. L. 101-246), pursuant to sec. 402(c)(5) of the Act; For Eritrea, the existing ongoing arms embargo referenced in 22 CFR 126.1(a), pursuant to sec. 402(c)(5) of the Act; For Iran, the existing ongoing travel restrictions based on serious human rights abuses under sec. 221(a)(1)(C) of the Iran Threat Reduction and Syria Human Rights Act of 2012, pursuant to sec. 402(c)(5) of the Act; For the Democratic People's Republic of Korea, the existing ongoing restrictions to which the Democratic People's Republic of Korea is subject, pursuant to sec. 402 and 409 of the Trade Act of 1974 (the Jackson-Vanik Amendment), pursuant to sec. 402(c)(5) of the Act; For Saudi Arabia, a waiver as required in the ``important national interest of the United States,'' pursuant to sec. 407 of the Act; For Sudan, the restriction in the annual Department of State, Foreign Operations, and Related Programs Appropriations Act on making certain appropriated funds available for assistance to the Government of Sudan, currently set forth in sec. 7042(k) of the Department of State, Foreign Operations, and Related Programs Appropriations Act, 2015 (Div. J, Pub. L. 113-235), and any provision of law that is the same or substantially the same as this provision, pursuant to sec. 402(c)(5) of the Act; For Tajikistan, a waiver as required in the ``important national interest of the United States,'' pursuant to sec. 407 of the Act; For Turkmenistan, a waiver as required in the ``important national interest of the United States,'' pursuant to sec. 407 of the Act; For Uzbekistan, a waiver as required in the ``important national interest of the United States,'' pursuant to sec. 407 of the Act.
U.S. Advisory Commission on Public Diplomacy
Document Number: 2016-09162
Type: Notice
Date: 2016-04-20
Agency: Department of State
Culturally Significant Objects Imported for Exhibition Determinations: “Turner's Whaling Pictures” Exhibition
Document Number: 2016-09161
Type: Notice
Date: 2016-04-20
Agency: Department of State
Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), E.O. 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681, et seq.; 22 U.S.C. 6501 note, et seq.), Delegation of Authority No. 234 of October 1, 1999, Delegation of Authority No. 236-3 of August 28, 2000 (and, as appropriate, Delegation of Authority No. 257-1 of December 11, 2015), I hereby determine that the objects to be included in the exhibition ``Turner's Whaling Pictures,'' imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to a loan agreement with the foreign owner or custodian. I also determine that the exhibition or display of the exhibit objects at The Metropolitan Museum of Art, New York, New York, from on or about May 10, 2016, until on or about August 7, 2016, and at possible additional exhibitions or venues yet to be determined, is in the national interest. I have ordered that Public Notice of these Determinations be published in the Federal Register.
Clarification of Requirements for Method 303 Certification Training
Document Number: 2016-09157
Type: Rule
Date: 2016-04-20
Agency: Environmental Protection Agency
Because the Environmental Protection Agency (EPA) received adverse comment, we are withdrawing the direct final rule for Clarification of Requirements for Method 303 Certification Training, published on February 25, 2016.
Proposed Information Collection Request; Comment Request; Control of Evaporative Emissions From New and In-Use Portable Gasoline Containers (Renewal), ICR 2213.05, OMB 2060-0597
Document Number: 2016-09156
Type: Notice
Date: 2016-04-20
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is planning to submit an information collection request (ICR), '' Control of Evaporative Emissions from New and In-Use Portable Gasoline Containers (Renewal)'', ICR 2213.05, OMB 2060-0597 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.). Before doing so, EPA is soliciting public comments on specific aspects of the proposed information collection request as described below. This notice is a proposed extension of the Portable Fuel Container ICR, which is currently approved through August 31, 2016. 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.
Aquashade, Nithiazine, d-limonene, and 2H-Cyclopent(d)isothiazol-3(4H)-one, 5,6-dihydro-2-methyl- (MTI) Registration Review Interim Decisions; Notice of Availability
Document Number: 2016-09155
Type: Notice
Date: 2016-04-20
Agency: Environmental Protection Agency
This notice announces the availability of EPA's interim registration review decisions for the pesticides aquashade, nithiazine, d-limonene, and 2H-Cyclopent(d)isothiazol-3(4H)-one, 5,6-dihydro-2- methyl- (MTI). Registration review is EPA's periodic review of pesticide registrations to ensure that each pesticide continues to satisfy the statutory standard for registration, that is, that the pesticide can perform its intended function without causing unreasonable adverse effects on human health or the environment. Through this program, EPA is ensuring that each pesticide's registration is based on current scientific and other knowledge, including its effects on human health and the environment.
Notice of Availability of a Draft Programmatic Environmental Assessment for Fisheries and Ecosystem Research Conducted and Funded by the National Marine Fisheries Service, Southeast Fisheries Science Center
Document Number: 2016-09154
Type: Notice
Date: 2016-04-20
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS announces the availability of the ``Draft Programmatic Environmental Assessment (DPEA) for Fisheries and Ecosystem Research Conducted and Funded by the Southeast Fisheries Science Center (SEFSC).'' Publication of this notice begins the official public comment period for this DPEA. The purpose of the DPEA is to evaluate, in compliance with the National Environmental Policy Act (NEPA), the potential direct, indirect, and cumulative impacts of conducting and funding fisheries and ecosystem research in the southeastern coast of the U.S., the Gulf of Mexico, and the Caribbean Sea marine waters of Puerto Rico and the U.S. Virgin Islands.
Enhanced-Use Lease of Department of Veterans Affairs Real Property for the Development of Affordable Housing Facility in Minneapolis, Minnesota
Document Number: 2016-09153
Type: Notice
Date: 2016-04-20
Agency: Department of Veterans Affairs
The Secretary of Veterans Affairs intends to enter into an Enhanced-Use Lease (EUL) on approximately 3 acres of land for the purpose of developing 100 units of affordable housing for Veterans. The EUL lessee, CHDC Veterans Limited Partnership, will finance, design, develop, manage, maintain, and operate housing for eligible homeless Veterans, or Veterans at risk of homelessness, on a priority placement basis, and provide services that guide resident Veterans toward attaining long-term self-sufficiency.
Animal Generic Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Generic Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate
Document Number: 2016-09152
Type: Notice
Date: 2016-04-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is issuing this notice to request that public stakeholders notify FDA of their intent to participate in periodic consultation meetings on reauthorization of the Animal Generic Drug User Fee Act (AGDUFA). The statutory authority for AGDUFA expires September 30, 2018. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA consult with a range of stakeholdersincluding patient and consumer advocacy groups, veterinary professionals, and scientific and academic experts in developing recommendations for the next AGDUFA program, and hold discussions with these stakeholders at least once every 4 months during FDA's negotiations with the regulated industry. The purpose of this request for notification is to ensure continuity and progress in these regular discussions by establishing consistent stakeholder representation.
Animal Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate
Document Number: 2016-09151
Type: Notice
Date: 2016-04-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is issuing this notice to request that public stakeholders notify FDA of their intent to participate in periodic consultation meetings on reauthorization of the Animal Drug User Fee Act (ADUFA). The statutory authority for ADUFA expires September 30, 2018. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA consult with a range of stakeholdersincluding patient and consumer advocacy groups, veterinary professionals, and scientific and academic expertsin developing recommendations for the next ADUFA program, and hold discussions with these stakeholders at least once every 4 months during FDA's negotiations with the regulated industry. The purpose of this request for notification is to ensure continuity and progress in these regular discussions by establishing consistent stakeholder representation.
Animal Generic Drug User Fee Act; Public Meeting; Request for Comments
Document Number: 2016-09150
Type: Notice
Date: 2016-04-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public meeting on the Animal Generic Drug User Fee Act (AGDUFA). FDA invites public comment on the AGDUFA program and suggestions regarding the features FDA should propose for the next AGDUFA program.
Agency Information Collection Activities; Proposed Collection; Comment Request; Agreement for Shipment of Devices for Sterilization
Document Number: 2016-09149
Type: Notice
Date: 2016-04-20
Agency: Food and Drug Administration, Department of Health and Human Services
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 information collection requirements relating to shipment of nonsterile devices that are to be sterilized elsewhere or are shipped to other establishments for further processing, labeling, or repacking.
Animal Drug User Fee Act; Public Meeting; Request for Comments
Document Number: 2016-09148
Type: Notice
Date: 2016-04-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public meeting on the Animal Drug User Fee Act (ADUFA). FDA invites public comment on the ADUFA program and suggestions regarding the features FDA should propose for the next ADUFA program.
Notice of Agreements Filed
Document Number: 2016-09146
Type: Notice
Date: 2016-04-20
Agency: Federal Maritime Commission, Agencies and Commissions
Diablo Canyon Power Plant, Units 1 and 2
Document Number: 2016-09145
Type: Notice
Date: 2016-04-20
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) is giving notice that Friends of the Earth (FOE or petitioner) filed a Petition to Intervene and Request for Hearing concerning Diablo Canyon Power Plant (DCPP) on August 26, 2014, asserting, in part, its concerns about DCPP's operational safety and ability to safely shut down in the event of a nearby earthquake. The Commission referred those concerns to the NRC's Executive Director for Operations (EDO) for consideration. The petitioner's requests are included in the SUPPLEMENTARY INFORMATION section of this document.
Preparation for International Cooperation on Cosmetics Regulation
Document Number: 2016-09143
Type: Notice
Date: 2016-04-20
Agency: Food and Drug Administration, Department of Health and Human Services
Distributor Labeling for New Animal Drugs; Guidance for Industry; Availability
Document Number: 2016-09141
Type: Notice
Date: 2016-04-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of guidance for industry #231 entitled ``Distributor Labeling for New Animal Drugs.'' This guidance discusses FDA's current thinking with respect to the factors it considers in determining whether to take regulatory action against distributor labeling for a new animal drug that differs from the labeling approved as part of a new animal drug application or abbreviated new animal drug application in ways other than those permitted by regulation.
Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2016-09140
Type: Notice
Date: 2016-04-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance entitled ``Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices.'' This guidance provides industry and Agency staff with recommendations regarding the technical performance assessment data for the evaluation of a digital whole slide imaging (WSI) system. The guidance provides suggestions on how to best characterize the technical aspects that are relevant to WSI performance for their intended use and determine any possible limitations that might affect their safety and effectiveness.
Amendment to the Definition of “Condition” and Prerequisite Requirement for Shell Eggs Eligible for Grading and Certification Stated in the Regulations Governing the Voluntary Grading of Shell Eggs
Document Number: 2016-09139
Type: Proposed Rule
Date: 2016-04-20
Agency: Agricultural Marketing Service, Department of Agriculture
The Agricultural Marketing Service (AMS) proposes to amend the Regulations Governing the Voluntary Grading of Shell Eggs to clarify the definition of ``condition'' and revise the prerequisite requirement for shell eggs eligible for voluntary USDA grading and certification. The proposed revision to the prerequisite requirement will prohibit the use of Salmonella Enteritidis-adulterated or recalled shell eggs from being presented to USDA for grading and certification. AMS is proposing to revise the definition of ``condition'' to remove any food safety implications resulting from the use of the term ``wholesomeness'' and clarify that AMS' role in grading and certification of shell eggs is solely for a quality determination.
Submission for Review: 3206-0226, It's Time To Sign Up for Direct Deposit or Direct Express, RI 38-128
Document Number: 2016-09138
Type: Notice
Date: 2016-04-20
Agency: Office of Personnel Management
The Retirement Services, Office of Personnel Management (OPM) offers the general public and other federal agencies the opportunity to comment on an extension without change of a currently approved information collection request (ICR) 3206-0226, It's Time To Sign Up for Direct Deposit or Direct Express. As required by the Paperwork Reduction Act of 1995, (Pub. L. 104-13, 44 U.S.C. chapter 35) as amended by the Clinger-Cohen Act (Pub. L. 104-106), OPM is soliciting comments for this collection. The information collection was previously published in the Federal Register on February 22, 2016, at Volume 81 Issue 34 Page 8760 allowing for a 60-day public comment period. No comments were received for this information collection. The purpose of this notice is to allow an additional 30 days for public comments. The Office of Management and Budget is particularly interested in comments that: 1. Evaluate whether the proposed collection of information is necessary for the proper performance of 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.
Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information; Draft Guidance for Industry; Availability
Document Number: 2016-09137
Type: Notice
Date: 2016-04-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information.'' This document is a revised version of a draft guidance that published in February 2003 entitled ``Comparability Protocols: Chemistry, Manufacturing, and Controls Information.'' A related draft guidance entitled ``Comparability ProtocolsProtein Drug Products and Biological ProductsChemistry, Manufacturing, and Controls Information,'' that published in September 2003, was withdrawn on May 6, 2015. The revised draft guidance provides recommendations to human drug and biologics manufacturers on implementing a chemistry, manufacturing, and controls (CMC) postapproval change(s) through the use of a comparability protocol (CP). By using a CP, manufacturers who fall within the scope of this guidance will not have to submit commercial- scale CMC information on postchange products to FDA before making the proposed change. This draft guidance is intended to establish a framework to promote manufacturing of quality drug products.