Department of Health and Human Services August 2017 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy DevicesDraft Guidance for Industry and Food and Drug Administration Staff.'' When final, this draft guidance will clarify FDA's policy related to compliance with applicable performance standards and conformance to International Electrotechnical Commission (IEC) consensus standards for ultrasonic diathermy devices. This draft guidance will also provide recommendations for information to provide in 510(k) submissions for ultrasonic diathermy devices. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of another draft chapter of a multichapter guidance for industry entitled ``Hazard Analysis and Risk-Based Preventive Controls for Human Food: Guidance for Industry.'' This multichapter draft guidance is intended to explain our current thinking on how to comply with the requirements for hazard analysis and risk- based preventive controls under our rule entitled ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.'' The newly available draft chapter is entitled ``Chapter SixUse of Heat Treatments as a Process Control.''

In accordance with the Federal Advisory Committee Act, notice is hereby given that a meeting is scheduled for the Centers for Disease Control and Prevention (CDC)/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment. This meeting will be open to the public. Information about the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment and the agenda for this meeting can be obtained by contacting CDR Holly Berilla at (301) 443-9965 or hberilla@hrsa.gov.

The Agency for Toxic Substances and Disease Registry (ATSDR), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed request to extend the information collect project titled ``Assessment of Chemical Exposures (ACE) Investigations.'' The purpose of ACE Investigations is to focus on performing rapid epidemiological assessments to assist state, regional, local, or tribal health departments (the requesting agencies) to respond to or prepare for acute chemical releases.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for KENGREAL and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA or Agency) has determined that CENESTIN (estrogens, conjugated synthetic A) Tablets, 0.3 milligrams (mg), 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for these products, if all other legal and regulatory requirements are met.

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 Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Generic Drug User Fee Amendments of 2017 (GDUFA II), authorizes FDA to assess and collect fees for abbreviated new drug applications (ANDAs), drug master files (DMFs), generic drug active pharmaceutical ingredient (API) facilities, finished dosage form (FDF) facilities, contract manufacturing organization (CMO) facilities, and generic drug applicant program user fees. In this document the Food and Drug Administration (FDA or Agency) is announcing fiscal year (FY) 2018 rates for GDUFA fees.

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), 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.

The U.S. Department of Health and Human Services (HHS) hereby gives notice of its intent to establish the Pain Management Best Practices Inter-Agency Task Force (Task Force) pursuant to section 101 of the Comprehensive Addiction and Recovery Act of 2016. The Task Force will consist of representatives of specific Federal agencies and non- federal individuals and entities who represent diverse disciplines and views. The Task Force will provide advice and recommendations for development of best practices for pain management and prescribing pain medication and a strategy for disseminating such best practices to relevant Federal agencies and the general public. Through this notice, HHS is also requesting nominations of individuals who are interested in being considered for appointment to the Task Force. Resumes or curricula vitae from qualified individuals who wish to be considered for appointment as a member of the Task Force are currently being accepted.

In accordance with the Federal Advisory Committee Act, notice is hereby given of a National Advisory Committee on Rural Health and Human Services (NACRHHS) meeting. The meeting will be open to the public. Informaton about the NACRHHS meeting can be obtained by accessing the following Web site: https://www.hrsa.gov/ advisorycommittees/rural/.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

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 Regulatory Flexibility Act of 1980 and Executive Order (EO) 12866 require the semiannual issuance of an inventory of rulemaking actions under development throughout the Department, offering for public review summarized information about forthcoming regulatory actions.

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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry #237 entitled ``Oncology Drugs for Companion Animals.'' The guidance provides recommendations for sponsors of investigational oncology drugs for use in companion animals (e.g., dogs, cats, and horses), discusses the contents of a new animal drug application for certain oncology drugs, and provides recommendations on how to address human user safety concerns.

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.

As steward of the National Occupational Research Agenda (NORA), the National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention announces the availability of the draft National Occupational Research Agenda for Manufacturing for public comment. Written by the NORA Manufacturing Sector Council, the Agenda identifies the most important occupational safety and health research needs for the next decade, 2016-2026. A copy of the draft Agenda is available at https://www.regulations.gov (search Docket Number CDC-2017-0072).

This notice acknowledges that in accordance with section 1890(b)(5)(B) of the Social Security Act (the Act) the Secretary of the Department of Health and Human Services (the Secretary) has received and reviewed the National Quality Forum (NQF) Report of 2016 Activities to Congress and the Secretary of the Department of Health and Human Services submitted by the consensus-based entity with whom the Secretary has a contract under section 1890(a) of the Act. The purpose of this Federal Register notice is to publish the report, together with the Secretary's comments on such report.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comments on the information collection extension request titled ``Adverse Events among Persons on Treatment of Latent Tuberculosis Infection.''

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.

The Food and Drug Administration (FDA, Agency, 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 (PRA).

The Food and Drug Administration (FDA or Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 047'' (Recognition List Number: 047), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

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 to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the National Health Interview Survey (NHIS). The annual National Health Interview Survey is a major source of general statistics on the health of the U.S. population.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Identifying Trading Partners Under the Drug Supply Chain Security Act'' (draft trading partner guidance). FDA is issuing this guidance to assist industry and State and local governments in understanding how to categorize the entities in the drug supply chain in accordance with the Drug Supply Chain Security Act (DSCSA). This guidance explains how to determine when certain statutory requirements will apply to entities that may be considered trading partners in the drug supply chain. FDA is also soliciting public input specific to the activities of ``private-label distributors'' of drug products and whether those activities fall within the definitions under DSCSA of the various trading partners.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for RECUVYRA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that animal drug product.

The Food and Drug Administration (FDA, the Agency, or we) is establishing a public docket to assist with its development of recommendations regarding the communication of risk information in direct-to-consumer (DTC) broadcast advertisements for prescription drugs and biologics.

The Department of Health and Human Services is hereby giving notice that the charter for the National Vaccine Advisory Committee (NVAC) has been renewed.

This notice announces the intention of the Agency for

The Centers for Disease Control and Prevention (CDC) in the

This proposed rule proposes to cancel the Episode Payment Models (EPMs) and Cardiac Rehabilitation (CR) incentive payment model and to rescind the regulations governing these models. It also proposes to revise certain aspects of the Comprehensive Care for Joint Replacement (CJR) model, including: Giving certain hospitals selected for participation in the CJR model a one-time option to choose whether to continue their participation in the model; technical refinements and clarifications for certain payment, reconciliation and quality provisions; and a change to increase the pool of eligible clinicians that qualify as affiliated practitioners under the Advanced Alternative Payment Model (APM) track.

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 to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the information collection project titled ``Assessing Education Agency Staff Perceptions of School Climate and Youth Access to Services.'' This study provides in-depth assessment of HIV and STD prevention efforts in three local education agencies funded by CDC's Division of Adolescent and School Health.

A notice was published in the Federal Register on Monday, July 17, 2017 (Vol. 82, No. 135, pages 32711-32712), to solicit nominations of individuals who are interested in being considered for appointment to the Tick-Borne Disease Working Group (Working Group). The nomination period is scheduled to end close of business on August 16, 2017. The notice is being amended to extend the solicitation period for one week to allow more time for interested individuals to submit nominations.

The Food and Drug Administration (FDA or Agency) has determined that CORDARONE (amiodarone hydrochloride) tablets, 200 milligrams (mg), 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 this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

The Secretary of Health and Human Services (Secretary), in accordance with section 6031 of the 21st Century Cures Act, announces the inaugural meeting of the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC). The ISMICC will meet on August 31, 2017, from 9:00 a.m. to 5:00 p.m., Eastern Time. The meeting will be held at the Hubert H. Humphrey Building, 200 Independence Avenue SW., Room 800, Washington, DC 20201. The meeting will include information on federal advances related to serious mental illness (SMI) and serious emotional disturbance (SED), including data evaluation, and recommendations for action. Committee members will also discuss workgroups, future meetings, and the Report to Congress. Members of the public can attend the meeting via telephone or webcast. The meeting can be accessed via webcast at www.hhs.gov/live. To obtain the call-in number and access code, submit written or brief oral comments, or request special accommodations for persons with disabilities, please register at the SAMHSA Advisory Committees Web site at https://www.samhsa.gov/about-us/advisory-councils/smi-committ ee or contact Pamela Foote, Designated Federal Official (see contact information below). Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written statements should be submitted to the DFO on or before August 24, 2017. Oral presentations from the public will be scheduled at the conclusion of the meeting. Individuals interested in making oral presentations are encouraged to notify the DFO on or before August 24, 2017. Two minutes will be allotted for each presentation. Substantive meeting information and a roster of Committee members is available at the Committee's Web site https://www.samhsa.gov/about- us/advisory-councils/smi-committee or by contacting Pamela Foote, DFO. Committee Name: Interdepartmental Serious Mental Illness Coordinating Committee Dates/Time/Type: August 31, 2017/9:00 a.m.5:00 p.m./OPEN Place: Hubert H. Humphrey Building, 200 Independence Avenue SW., Room 800, Washington, DC 20201. Webcast and teleconference (see information above). DFO: Pamela Foote, Substance Abuse and Mental Health Services Administration, 5600 Fishers Lane, 14E53C, Rockville, MD 20857; telephone: 240-276-1279; email: pamela.foote@samhsa.hhs.gov

The Food and Drug Administration (FDA or Agency) is announcing the availability for public comment of a proposed method for applying a food animal biomass denominator to annual data on antimicrobials sold and distributed for use in food animals in the United States. This method will allow us to obtain a corrected estimate of antimicrobial drug sales relative to the animal population potentially being treated with those drugs, thereby lending further context to the antimicrobial sales data we are collecting and analyzing.

AIDD intends to reallot funds under authority of the Development Disabilities Assistance and Bill of Rights Act of 2000 which states: ``If the Secretary determines that an amount of an allotment to a State for a period (of a fiscal year or longer) will not be required by the State during the period for the purpose for which the allotment was made, the Secretary may reallot the amount.'' AIDD will be reallotting FY 2017 funds awarded to the State Council on Developmental Disabilities (SCDD) and the Protection & Advocacy (P&A) agency located within the Commonwealth of Puerto Rico. This determination is based on the limited reported expenditures and requests for reimbursement over the last several years from the SCDD and P&A in the Commonwealth of Puerto Rico. The Puerto Rico SCDD will have up to $1.9 million rescinded and proportionately redistributed to the remaining SCDDs. SCDDs that receive FY 2017 realloted funds will have through the end of FY 2018 to obligate the funds and until the end of FY 2019 to liquidate the funds. The Puerto Rico P&A will have up to $550,000 rescinded and proportionately redistributed to the remaining P&As. P&As that receive the FY 2017 funds will have through the end of FY 2019 to spend the funds. Realloted funds for both the SCDDs and the P&As must be used according to the terms as outlined in the FY 2017 Notice of Award for each program.

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), announces the following meeting for the aforementioned subcommittee. This meeting is open to the public, but without a public comment period. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcome to listen to the meeting by joining the teleconference at the USA toll-free, dial-in number at 1-866-659-0537 and the pass code is 9933701. The conference line has 150 ports for callers.

In accordance with section 10(a)(2) of the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the aforementioned committee. This meeting is open to the public. The public comment period is from 12:30 p.m. to 12:45 p.m. Please note that the public comment period ends at the time indicated above or following the last call for comments, whichever is earlier. Each commenter will be provided up to five minutes for comment. A limited number of time slots are available and will be assigned on a first come-first served basis. Written comments will also be accepted from those unable to attend the public session via an on-line form at the following Web site: https://www.cdc.gov/ niosh/bsc/contact.html. This meeting is open to the public, limited only by the space available. The meeting room accommodates approximately 33 people. The meeting is also open to the public via webcast. If you wish to attend in person or by webcast, please see the NIOSH Web site to register (https://www.cdc.gov/niosh/bsc/) or call (404-498-2539) at least five business days in advance of the meeting. Teleconference is available toll-free; please dial (888) 397-9578, Participant Pass Code 63257516. Adobe Connect webcast will be available at https:// odniosh.adobeconnect.com/nioshbsc/ for participants wanting to connect remotely.

The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Ultrafiltered Milk in the Production of Standardized Cheeses and Related Cheese Products: Guidance for Industry.'' The guidance advises manufacturers who wish to use ultrafiltered milk (UF milk) or ultrafiltered nonfat milk (UF nonfat milk) in the production of standardized cheeses and related cheese products that, pending completion of a rulemaking regarding the use of UF milk in the production of these products, we intend to exercise enforcement discretion regarding the use of fluid UF milk and fluid UF nonfat milk in the production of standardized cheeses and related cheese products. We also intend to exercise enforcement discretion regarding the declaration of ingredients in the labeling of standardized cheeses and related cheese products when fluid UF milk and fluid UF nonfat milk are used as ingredients.

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 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 Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule.'' This guidance is intended to assist persons who manufacture, package, sell, offer to sell, distribute, or import for sale and distribution within the United States newly regulated tobacco products, roll-your-own (RYO) tobacco, and cigarette tobacco in complying with the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), and FDA regulations.

As steward of the National Occupational Research Agenda (NORA), the National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention announces the availability of the draft National Occupational Research Agenda for Cancer, Reproductive, Cardiovascular and Other Chronic Disease Prevention Agenda for public comment. Written by the NORA Cancer, Reproductive, Cardiovascular and Other Chronic Disease Prevention Cross-Sector Council, the Agenda identifies the most important occupational safety and health research needs for the next decade, 2016-2026. A copy of the draft Agenda is available at https:// www.regulations.gov (search Docket Number CDC-2017-0068).

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ``Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products.'' The last few decades have seen an increasing demand in various health care settings for solid oral dosage form drug products repackaged into unit-dose containers, which hold a quantity of drug for administration as a single dose. The increase in unit-dose repackaging has led to questions regarding stability studies and appropriate expiration dates for these repackaged products. This revised draft guidance describes the conditions under which FDA does not intend to take action regarding required stability studies for these repackaged products and the expiration date to assign under those conditions. Through this notice, FDA is hoping to decrease the regulatory burdens of drug regulations on manufacturers of these products, while at the same time ensuring patient safety. Since FDA's guidance documents do not bind the public or FDA to any requirements, they have not been considered to be subject to Executive Order 12866.

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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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 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.

The U.S. Department of Health and Human Services (HHS) announces the next meeting of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030 (Committee). The meeting is open to the public and will be held in the Washington, DC metropolitan area. The Committee is working to accomplish its mission to provide independent advice based on current scientific evidence for use by the Secretary of the U.S. Department of Health and Human Services or a designated representative in the development of Healthy People 2030.

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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of final product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The product- specific guidances identified in this notice were developed using the process described in that guidance.

The Food and Drug Administration (FDA, Agency, or we) 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 proposed extension of the collection of information concerning cooperative manufacturing arrangements for licensed biologics.

The National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to MiRecule, Inc., located in Rockville, Maryland, to practice the inventions embodied in the patent applications listed in the SUPPLEMENTARY INFORMATION section of this notice.