Department of Health and Human Services 2018 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.'' This guidance concerns FDA's implementation of the Biosimilar User Fee Amendments of 2017 (BsUFA II) and certain changes in policies and procedures surrounding its application.

The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) in the Food and Drug Administration (FDA or Agency) are announcing a 2018 CDER and CBER staff experiential learning site visit program specific to FDA's Quality Metrics Program. FDA is proposing this program, in part, in response to input from a variety of stakeholders over the past couple of years. The purpose of this 2018 Quality Metrics Site Visit Program is to provide experiential and firsthand learning opportunities to FDA staff involved in the development of the FDA Quality Metrics Program and to provide stakeholders with an opportunity to explain the advantages and challenges associated with implementing and managing a robust Quality Metrics Program. This notice invites pharmaceutical companies interested in participating in this program to submit a Quality Metrics Site Visit proposal.

This gives notice under (the Federal Advisory Committee Act of October 6, 1972, that the Healthcare Infection Control Practices Advisory Committee (HICPAC), Centers for Disease Control and Prevention, Department of Health and Human Services, has amended their charter to increase the number and meetings from approximately three times per year to up to eight times per year. Also, this amendment gives notice to change the name of the DNV Healthcare to DNV-GL; to add the American Society of Nephrology (ASN), the American Association of Kidney Patients (AAKP), the Pediatric Infectious Disease Society (PIDS), and the National Association of Directors of Nursing Administration (NADONA) as non-voting liaison organizations to the committee, and to include expertise in environmental microbiology; and increase the number of meetings up to eight times a year. The amended filing date is May 4, 2018.

This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Board of Scientific Counselors, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry (BSC, NCEH/ATSDR), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through May 21, 2020.

In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

Notice is hereby given of the meetings on July 22-23, 2018, of the Substance Abuse and Mental Health Services Administration's (SAMHSA) Tribal Technical Advisory Committee (TTAC); on July 23 and July 25, 2018, of the Centers for Disease Control and Prevention (CDC)/ Agency for Toxic Substances and Disease Registry (ATSDR) Tribal Advisory Committee (TAC); and on July 24, 2018, of the Joint Tribal Advisory Committee (JTAC).

This action removes outmoded regulations for the National Health Service Corps (NHSC) Program. The regulations were promulgated to implement Section 338G of the Public Health Service (PHS) Act, relating to private practice loans. The regulations have not been updated since they were issued in 1986. The regulations are no longer relevant or needed as the NHSC has not made private practice loan opportunities available since the 1980s, and does not plan to do so in the foreseeable future. The removal of these regulations will not create any challenges for other programs, as the law and regulations apply solely to NHSC clinicians.

This action removes the outmoded regulations for the Rural Physician Training Grant Program, Definition of ``Underserved Rural Community.'' Funding was authorized at section 749B(i) Public Health Service Act for fiscal years 2010-2013, but never appropriated for the Rural Physician Training Grant Program, and the program was not implemented. Therefore, this regulation is no longer relevant, and HRSA suggested the regulations defining underserved rural communities for the Rural Physician Training Grant Program be removed.

The Department of Health and Human Services (HHS) announces the seventh meeting of the Tick-Borne Disease Working Group (Working Group) on July 24, 2018, from 10:00 a.m. to 4:00 p.m., Eastern Time. The seventh meeting will be an on-line meeting held via webcast. The Working Group will review and vote on the content of the five chapters that will be included in the Working Group's Report to Congress.

The Agency for Toxic Substances and Disease Registry (ATSDR), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Environmental Health and Land Reuse Certification'' This certification is a joint collaboration with National Environmental Health Association (NEHA); ATSDR will jointly co-produce the course with NEHA.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Antimicrobial Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

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.

HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS 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.

In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. The ICR is for reinstatement with change of a previously approved information collection, assigned OMB control number 0915-0290, which expired on March 31, 2015. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

This request for information seeks input from the public on how to address any undue regulatory impact and burden of the physician self-referral law.

National Center for Advancing Translational Sciences, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in the Patent Applications listed in the Summary Information section of this notice to Apexx Oncology, Inc., located in New York, NY.

The National Institute of Dental and Craniofacial Research, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patent Applications listed in the Supplementary Information section of this notice to ERYTHRYx Therapeutics, located in Los Angeles, California.

This proposed notice acknowledges the receipt of an application from the American Association for Accreditation of Ambulatory Surgery Facilities, Inc. for continued recognition as a national accrediting organization for Ambulatory Surgical Centers that wish to participate in the Medicare or Medicaid programs.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Tobacco Products Scientific Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.

The National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention announces the availability of a draft NORA Agenda entitled National Occupational Research Agenda for Healthcare and Social Assistance (HCSA) for public comment. To view the notice and related materials, visit https:// www.regulations.gov and enter CDC-2018-0050 in the search field and click ``Search.''

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Antimicrobial Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (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 adverse event reporting for outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry entitled ``Mitigation Strategies to Protect Food Against Intentional Adulteration: Guidance for Industry.'' This draft guidance document, when finalized, will help food facilities that manufacture, process, pack, or hold food, and that are required to register under the Federal Food, Drug, and Cosmetic Act (FD&C Act) comply with the requirements of our regulation entitled ``Mitigation Strategies to Protect Food Against Intentional Adulteration.''

In a final rule published on January 19, 2017, a number of federal departments and agencies revised to the Federal Policy for the Protection of Human Subjects (often referred to as the ``Common Rule''), which each department and agency adopted into regulations in its part of the Code of Federal Regulations (CFR). The Consumer Product Safety Commission (CPSC) adopted the same changes in a final rule published on September 18, 2017. The revised Common Rule was scheduled to become effective on January 19, 2018, with a general compliance date of the same date. By an interim final rule issued on January 17, 2018 and published in the Federal Register on January 22, 2018, federal departments and agencies delayed the effective date and the general compliance date for the revised Common Rule for a 6-month period, until July 19, 2018. The Department of Housing and Urban Development (HUD) published an interim final rule adopting the same regulatory changes on January 26, 2018. The revised Common Rule, including technical amendments made by the January 22, 2018 interim final rule, is referred to here as the ``2018 Requirements.'' On April 20, 2018, the federal departments and agencies listed here published a notice of proposed rulemaking (NPRM) proposing and seeking comments as to whether the general compliance date for the 2018 Requirements should be delayed for an additional 6-month period. The NPRM also proposed and sought comments on whether to allow regulated entities to implement certain burden-reducing provisions of the 2018 Requirements in specified circumstances during such continued delay period. Through this final rule, we are adopting the proposals described in the April 20, 2018 NPRM. This rule delays the general compliance date for the 2018 Requirements for an additional 6-month period, until January 21, 2019. As a result of this delay, regulated entities will be required, with an exception, to continue to comply with the requirements of the pre-2018 version of the Federal Policy for the Protection of Human Subjects (the ``pre-2018 Requirements'') until January 21, 2019. The one exception to this general rule is that institutions will be permitted (but not required) to implement, for certain research, three burden-reducing provisions of the 2018 Requirements during the delay period (July 19, 2018, through January 20, 2019). Those three provisions are: The revised definition of ``research,'' which deems certain activities not to be research covered by the Common Rule; the elimination of the requirement for annual continuing review with respect to certain categories of research; and the elimination of the requirement that institutional review boards (IRBs) review grant applications or other funding proposals related to the research. Institutions taking advantage of the three-burden reducing provisions must comply with all other pre-2018 Requirements during the delay period. The three burden-reducing provisions of the 2018 Requirements can only be implemented during the delay period with respect to studies initiated prior to January 21, 2019 that will transition to compliance with the revised Common Rule. Any study that implements these three burden-reducing provisions during the delay period must, beginning on January 21, 2019, comply with all of the 2018 Requirements for the balance of the study's duration.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Epidermolysis Bullosa: Developing Drugs for Treatment of Cutaneous Manifestations.'' The purpose of this draft guidance is to assist sponsors with the development of drugs for treatment or prevention of the serious cutaneous manifestations of the heterogeneous group of disorders collectively known as epidermolysis bullosa (EB). There is an unmet medical need for EB patients due to the paucity of effective treatment options.

The Food and Drug Administration (FDA or Agency) is establishing a public docket to receive information, recommendations, and comments on matters related to the Agency's publication of technical specifications, which explain, clarify, and define the specific use of data standards in new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and certain investigational new drug applications (INDs) to the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). This docket is intended for general comments related to technical specifications that are not specific to documents or issues that are the subject of other dockets, or for comments specific to electronic submission guidances.

The Food and Drug Administration (FDA or we) is announcing a public meeting entitled ``Foods Produced Using Animal Cell Culture Technology.'' FDA is holding the public meeting to provide the public with an opportunity to provide comments related to the production of foods using animal cell culture technology.

The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled ``The Declaration of Certain Isolated or Synthetic Non-Digestible Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts Labels; Guidance for Industry.'' The guidance identifies eight specific, additional isolated or synthetic non-digestible carbohydrates that we intend to add to our regulatory definition of ``dietary fiber'' through our regular rulemaking process. In the interim, the guidance also advises manufacturers of our policy for when one or more of these eight non-digestible carbohydrates, present in a food, are included in the declared amount of ``dietary fiber,'' and for the use of a caloric value for polydextrose of 1 kilocalorie per gram (kcal/g).

This proposed notice acknowledges the receipt of an application from the Community Health Accreditation Partner (CHAP) for continued recognition as a national accrediting organization for hospices that wish to participate in the Medicare or Medicaid programs.

The National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, on behalf of the Centers for Disease Control and Prevention, Department of Health and Human Services, is contemplating the grant of an exclusive patent commercialization license to The University of Liverpool, located in Liverpool, UK, to practice the inventions embodied in the patent applications listed in the Supplementary Information section of this notice.

The Food and Drug Administration (FDA or we) is classifying the fluid jet system for prostate tissue removal into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the fluid jet system for prostate tissue removal's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Coronary, Peripheral, and Neurovascular GuidewiresPerformance Tests and Recommended Labeling.'' This draft guidance provides recommendations for the information and testing that should be included in premarket submissions for guidewires intended for use in the coronary, peripheral, and neurovasculature. This draft guidance is not final nor is it in effect at this time.

NIOSH announces the availability of the final National Occupational Research Agenda for Agriculture, Forestry, and Fishing.

In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of two abbreviated new drug applications (ANDAs) from Ferring Pharmaceuticals, Inc. (Ferring). Ferring notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

The Food and Drug Administration (FDA or we) is classifying the brain trauma assessment test into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the brain trauma assessment test's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS), in cooperation with the General Services Administration (GSA), announces its intent to prepare an Environmental Impact Statement (EIS) to analyze and assess the environmental impacts of the proposed acquisition of a site in Mace, West Virginia, and the development of this site into a replacement of the National Institute for Occupational Safety and Health (NIOSH) Underground Safety Research Program facility (Proposed Action). The current acquisition and development would replace the former Lake Lynn Experimental Mine in Fayette County, Pennsylvania and would support research programs focused on miner health and safety issues. The site being considered for acquisition and development includes 461.35 acres located off of U.S. Route 219 in Randolph and Pocahontas Counties near Mace, West Virginia. This notice is pursuant to the requirements of the National Environmental Policy Act of 1969 (NEPA) as implemented by the Council on Environmental Quality (CEQ) Regulations (40 CFR parts 1500-1508). CDC, in cooperation with GSA, also intends to initiate consultation, as required by Section 106 of the National Historic Preservation Act (NHPA), to evaluate the potential effects, if any, of the Proposed Action on historic properties. Following the scoping meeting, a Draft EIS will be prepared and circulated for public comment. CDC is the lead federal agency for this Proposed Action.

Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP and the full meeting agenda will be posted on the SACHRP website at: http:/ /www.dhhs.gov/ohrp/sachrp-committee/meetings/.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled the National Notifiable Diseases Surveillance System (NNDSS). The NNDSS is the nation's public health surveillance system that monitors the occurrence and spread of diseases and conditions that are nationally notifiable or under standard surveillance.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Limited Population Pathway for Antibacterial and Antifungal Drugs.'' This guidance provides information on the implementation of the limited population pathway provision of the 21st Century Cures Act (Cures Act), which established the limited population pathway for antibacterial and antifungal drugs (LPAD pathway).

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Humanitarian Device Exemption (HDE) Program.'' This draft guidance concerns the HDE program as a whole and, among other topics, it explains the criteria FDA considers to determine if ``probable benefit'' has been demonstrated as part of the Agency's decision-making process regarding marketing authorization for a humanitarian use device (HUD). The draft guidance also incorporates recent amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) that affect the HDE program and answers other common questions that we receive about the program. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Medical Product Communications That Are Consistent With the FDA-Required Labeling Questions and Answers.'' This guidance provides information for manufacturers, packers, and distributors and their representatives (collectively ``firms'') of drugs and medical devices for humans, including those that are licensed as biological products, and animal drugs (collectively ``medical products''), about how FDA evaluates their medical product communications that present information that is not contained in the FDA-required labeling for the product but that may be consistent with the FDA-required labeling for the product. The Agency is issuing this guidance to explain FDA's current thinking on commonly asked questions regarding such communications to provide clarity for firms. FDA is also 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.

The Food and Drug Administration (FDA or we) 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.

The Food and Drug Administration (FDA or we) 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.

The Food and Drug Administration (FDA) is announcing the renewal of the Drug Safety and Risk Management Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Drug Safety and Risk Management Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until May 31, 2020.

The Food and Drug Administration (FDA) is announcing the renewal of the Pharmacy Compounding Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Pharmacy Compounding Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until April 25, 2020.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, National Center for Injury Prevention and Control, (BSC, NCIPC).

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Monitoring Changes in Attitudes and Practices among Family Planning Providers and Clinics. This project seeks to obtain information on changes in attitudes and practices among family planning providers and clinics in the United States related to recommendations from national contraception guidelines.

The Food and Drug Administration (FDA or Agency) is extending the comment period for the advance notice of proposed rulemaking (ANPRM) that appeared in the Federal Register of March 21, 2018. In the ANPRM, FDA requested information related to the role that flavors play in tobacco products. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

The Food and Drug Administration (FDA or the Agency) is extending the comment period for the advance notice of proposed rulemaking (ANPRM) that appeared in the Federal Register of March 26, 2018. In the ANPRM, FDA requested comments, data, research results, or other information that may inform regulatory actions FDA might take with respect to premium cigars. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

The Council is to advise the Secretary of HHS (Secretary) and the Director of the Agency for Healthcare Research and Quality (AHRQ) on matters related to activities of the Agency to carry out its mission. AHRQ's mission is to produce evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and to work within the U.S. Department of Health and Human Services and with other partners to make sure that the evidence is understood and used.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (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 provisions of the Interstate Shellfish Dealer's Certificate.

The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.