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

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses.'' This guidance provides recommendations to facilitate study designs to establish the performance characteristics of in vitro diagnostic devices (IVDs) intended for the detection, or detection and differentiation, of human papillomaviruses (HPVs). This guidance replaces a previously issued final guidance entitled ``Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection, or Detection and Differentiation of Human Papillomaviruses,'' dated November 28, 2011.

The Food and Drug Administration (FDA or Agency) has determined that TIMOPTIC (timolol maleate ophthalmic solution), 0.25 percent and 0.5 percent, was not withdrawn from sale for reasons of safety or effectiveness.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.

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. The ICR is for reinstatement with change of a previously approved information collection assigned OMB control number 0915-0343 that expired on May 31, 2014. OMB will accept further comments from the public during the review and approval period.

In compliance with the requirement of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Office of Intramural Research (OIR), Office of the Director (OD), 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 inventions listed below are owned by an agency of the U.S. Government and are available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on ACL's intention to collect information necessary to determine grantee compliance with Section 4 of the Assistive Technology Act of 1998, as amended (AT Act). Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish a 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 proposed action. This notice solicits comments on a proposed revision to an existing information collection related to the State Grants for Assistive Technology Program State Plan for AT, formerly the 664 Report.

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.

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 Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public, limited only by the space available. Time will be available for public comment. The public is welcome to submit written comments in advance of the meeting. Comments should be submitted in writing by email to the contact person listed below. The deadline for receipt is October 11, 2017. Written comments must include full name, address, organizational affiliation, email address of the speaker, topic being addressed and specific comments. Written comments must not exceed one single-spaced typed page with 1- inch margins containing all items above. Only those written comments received 10 business days in advance of the meeting will be included in the official record of the meeting. Public comments made in attendance must be no longer than 3 minutes and the person giving comments must attend the public comment session at the start time listed on the agenda. Time for public comments may start before the time indicated on the agenda. The meeting will be webcast live via the World Wide Web; for instructions and more information on ACIP please visit the ACIP Web site: https://www.cdc.gov/vaccines/acip/.

The Food and Drug Administration (FDA) is announcing the rates for biosimilar user fees for fiscal year (FY) 2018. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Amendments of 2017 (BsUFA II), authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development; review of certain applications for approval of biosimilar biological products; and each biosimilar biological product approved in a biosimilar biological product application. BsUFA II directs FDA to establish, before the beginning of each fiscal year, the amount of initial and annual biosimilar biological product development (BPD) fees, the reactivation fee, and the biosimilar biological product application and program fees for such year. These fees apply to the period from October 1, 2017, through September 30, 2018.

The Food and Drug Administration (FDA or we) is announcing that Arcadia Biosciences, Inc. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of gamma-linolenic acid (GLA) safflower oil as a source of omega-6 fatty acids in dry food for adult cats in the maintenance life stage.

In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention (CDC), announces the following meeting of the Advisory Board on Radiation and Worker Health (ABRWH). 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; the pass code is 9933701. The conference line has 150 ports for callers.

The Food and Drug Administration (FDA, the Agency, or we) is proposing to extend, for covered produce other than sprouts, the dates for compliance with the agricultural water provisions in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule. We are proposing to extend the compliance dates to address questions about the practical implementation of compliance with certain provisions and to consider how we might further reduce the regulatory burden or increase flexibility while continuing to achieve our regulatory objectives, in keeping with the Administration's policies.

Government owned intellectual property covering HIV-1 reverse transcriptase inhibitors available for licensing and commercialization.

In the September 6, 2016 Federal Register (81 FR 61538), we published an interim final rule (IFR) issuing a new regulation to adjust for inflation the maximum civil monetary penalty amounts for the various civil monetary penalty authorities for all agencies within HHS. This correcting amendment corrects a limited number of technical and typographical errors identified in the CMS provisions of the September 6, 2016 IFR.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies.'' The purpose of this document is to outline FDA's recommendations and expectations for the evaluation and reporting of age, race, and ethnicity data in medical device clinical studies. The primary intent of these recommendations is to improve the quality, consistency, and transparency of data regarding the performance of medical devices within specific age, race, and ethnic groups.

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 Disease Control and Prevention (CDC) within the Department of Health and Human Services announces the next meeting of the Community Preventive Services Task Force (Task Force) on October 18-19, 2017 in Atlanta, Georgia.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). 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. Members will participate via teleconference.

In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on June 15, 2017, page 27516 (82 FR 27516) and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

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.

As part of the implementation of Executive Order 13771 entitled, ``Reducing Regulation and Controlling Regulatory Costs,'' and Executive Order 13777 entitled, ``Enforcing the Regulatory Reform Agenda,'' the Food and Drug Administration (FDA, Agency, or we) is seeking comments and information from interested parties to help FDA identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced, consistent with the law, to achieve meaningful burden reduction while allowing us to achieve our public health mission and fulfill statutory obligations. This document relates to the products regulated by the Center for Tobacco Products (CTP).

As part of the implementation of Executive Order 13771 entitled, ``Reducing Regulation and Controlling Regulatory Costs,'' and Executive Order 13777 entitled, ``Enforcing the Regulatory Reform Agenda,'' the Food and Drug Administration (FDA, Agency, or we) is seeking comments and information from interested parties to help FDA identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced, consistent with the law, to achieve meaningful burden reduction while allowing us to achieve our public health mission and fulfill statutory obligations. This document relates to the products regulated by the Center for Drug Evaluation and Research (CDER).

As part of the implementation of Executive Order 13771 entitled, ``Reducing Regulation and Controlling Regulatory Costs,'' and Executive Order 13777 entitled, ``Enforcing the Regulatory Reform Agenda,'' the Food and Drug Administration (FDA, Agency, or we) is seeking comments and information from interested parties to help FDA identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced, consistent with the law, to achieve meaningful burden reduction while allowing us to achieve our public health mission and fulfill statutory obligations. This document relates to the products regulated by the Center for Veterinary Medicine (CVM).

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Self-Collection Devices for Pap Test.'' The purpose of the public workshop is to obtain feedback about the feasibility, benefits, risks, impact on current standard of care, and least burdensome validation approaches for self- collection devices for cervical samples for the purpose of cervical cancer screening by Pap testing. Comments and suggestions generated through this workshop will guide the development of an appropriate least burdensome regulatory framework for the evaluation of cervical sample self-collection devices to be used for cervical cancer screening of patients.

The Food and Drug Administration (FDA or Agency) has determined that RITALIN LA (methylphenidate hydrochloride) extended- release capsules, 60 milligrams (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 methylphenidate hydrochloride extended-release capsules, 60 mg, if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.'' FDA is issuing this guidance to assist industry and FDA staff in identifying specific considerations related to the ability of electronic medical devices to safely and effectively exchange and use exchanged information. This document highlights considerations that should be included in the development and design of interoperable medical devices and provides recommendations for the content of premarket submissions and labeling for such devices.

The Food and Drug Administration (FDA) is correcting a document entitled ``B. Braun Medical, Inc.; Withdrawal of Approval of Three New Drug Applications and One Abbreviated New Drug Application'' that appeared in the Federal Register of August 3, 2017 (82 FR 36150). The document was published with the incorrect docket number. This document corrects that error.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled ``Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: What You Need to Know About the FDA Regulation: Small Entity Compliance Guide.'' The small entity compliance guide (SECG) is intended to help small entities comply with the final rule entitled ``Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.''

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 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 comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comments on a request for an extension of an approved information collection entitled, CDC's Fellowship Management System. CDC uses the information collected for processes that aid and enhance the selection of fellowship participants and host sites and to track participant information that helps strengthen the current, emerging, and ever-changing public health workforce.

The Food and Drug Administration (FDA) is establishing a public docket to collect comments related to the pediatric post- marketing pharmacovigilance and drug utilization reviews of products posted between March 11, 2017, and September 12, 2017, on FDA's Web site but not presented at the September 12, 2017, Pediatric Advisory Committee (PAC) meeting. These reviews are intended to be available for review and comment by members of the PAC, interested parties (such as academic researchers, regulated industries, consortia, and patient groups), and the general public.

Availability for licensing U.S. Government owned intellectual property for commercial development.

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

This notice announces the changes made by the Medicare Access and CHIP Reauthorization of 2015 (MACRA) to section 1882 of the Social Security Act (the Act), which governs Medicare supplemental insurance. This notice also recognizes that the Model Regulation adopted by the National Association of Insurance Commissioners (NAIC) on August 29, 2016, is considered to be the applicable NAIC Model Regulation for purposes of section 1882 of the Act, subject to our clarifications that are set forth in this notice.

The Food and Drug Administration's (FDA or Agency) Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) are announcing the end of support for Version 1.2 of Clinical Data Interchange Standards Consortium Study Data Tabulation Model (SDTM) and an update to the FDA Data Standards Catalog. FDA will continue its support of the newer SDTM Version 1.3 and Version 1.4, which have been listed in the FDA Data Standards Catalog since December 2012 and August 2015, respectively. FDA support for SDTM Version 1.2 will end for studies that start 12 months after March 15, 2018.

The Food and Drug Administration (FDA or Agency) has determined that NIZORAL (ketoconazole) 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 NIZORAL, and it will allow FDA to continue to approve ANDAs that reference NIZORAL as long as they meet relevant legal and regulatory requirements.

The Food and Drug Administration (FDA or Agency) is announcing support for the most current version of Medical Dictionary for Regulatory Activities (MedDRA), end of support for earlier versions of MedDRA, and an update to the FDA Data Standards Catalog (Catalog) for study data provided in new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and investigational new drug applications (INDs) to the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER).

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.'' FDA is issuing this guidance to clarify how we evaluate real-world data to determine whether it may be sufficiently relevant and reliable to generate the types of real-world evidence that can be used in FDA regulatory decision-making for medical devices. The guidance describes the circumstances when real-world evidence can be used, and the scientific criteria that must be fulfilled in order to have confidence in the data. Finally, the guidance describes some examples of actual uses of real-world evidence that have already led to FDA decisions.

The National Toxicology Program (NTP) announces an expert panel meeting and is obtaining comment on a proposed approach to genomic dose-response modeling. Prior to the expert panel meeting, NTP will host four webinars that present other approaches to genomic dose- response modeling. The expert panel meeting and four webinar presentations leading up to the meeting are open to the public. Registration is requested for both in-person meeting attendance and oral comment; registration is required to access the meeting webcast. URLs for live and archived pre-meeting webinars will be available at https://ntp.niehs.nih.gov/about/org/ntpexpertpanel/.

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 comment on the proposed project titled ``ZEN Colombia Study: Zika in Pregnant Women and Children in Colombia.''

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft revised guidance for industry on generic digoxin tablets entitled ``Draft Guidance on Digoxin.'' The guidance, once finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for digoxin tablets.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for XTORO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application 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 the Agency) is withdrawing approval of an abbreviated new drug application (ANDA) for PROPRANOLOL HYDROCHLORIDE Extended-Release Capsules, held by Upsher- Smith Laboratories, Inc. (Upsher-Smith), 6701 Evenstad Dr., Maple Grove, MN 55369. Upsher-Smith has voluntarily requested that approval of this application be withdrawn and has waived its opportunity for a hearing.

The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2018. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device User Fee Amendments of 2017 (MDUFA IV), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2018, which apply from October 1, 2017, through September 30, 2018. To avoid delay in the review of your application, you should pay the application fee before or at the time you submit your application to FDA. The fee you must pay is the fee that is in effect on the later of the date that your application is received by FDA or the date your fee payment is recognized by the U.S. Treasury. If you want to pay a reduced small business fee, you must qualify as a small business before making your submission to FDA; if you do not qualify as a small business before making your submission to FDA, you will have to pay the higher standard fee. Please note that the establishment registration fee is not eligible for a reduced small business fee. As a result, if the establishment registration fee is the only medical device user fee that you will pay in FY 2018, you should not submit a FY 2018 Small Business Qualification and Certification request. This document provides information on how the fees for FY 2018 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.

The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2018 annual fee rate for recognized accreditation bodies and accredited certification bodies, and the fee rate for accreditation bodies applying to be recognized in the third-party certification program that is authorized by the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA).

Eunice Kennedy Shriver National Institute of Child Health and Human Development, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public to take this opportunity to comment on the ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery '' for approval under the Paperwork Reduction Act (PRA). This collection was developed as part of a Federal Government-wide effort to streamline the process for seeking feedback from the public on service delivery. This notice announces our intent to submit this collection to OMB for approval and solicits comments on specific aspects for the proposed information collection.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC). 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 inventions listed below are owned by an agency of the U.S. Government and are available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Bone, Reproductive and Urologic Drugs 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. FDA is establishing a docket for public comment on this document.

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, the Agency, or we) is announcing the availability of a guidance for industry entitled ``Mitigation Strategies to Protect Food Against Intentional Adulteration: What You Need To Know About the FDA Regulation: Small Entity Compliance Guide.'' The small entity compliance guide (SECG) is intended to help small entities comply with the final rule entitled ``Mitigation Strategies to Protect Food Against Intentional Adulteration.''

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.

HRSA announces the award of supplemental grants under the Zika Response and Preparedness Act to the territorial health departments of Puerto Rico, American Samoa, and U.S. Virgin Islands to address the unmet needs of women, children, and families who are or may be affected by Zika virus (ZIKV) infection.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry (GFI) #232 entitled ``Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish an Acute Reference Dose'' (VICH GL54). This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document is intended to address the nature and types of data that can be useful in determining a toxicological acute reference dose (ARfD) for residues of veterinary drugs, the studies that may generate such data, and how the ARfD may be calculated based on these data.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Peripheral and Central Nervous System Drugs 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. 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.

The Office of Pediatric Therapeutics, Food and Drug Administration (FDA), is announcing a public workshop entitled ``Advancing the Development of Pediatric Therapeutics (ADEPT): Application of ``Big Data'' to Pediatric Safety Studies.'' The purpose of this 2-day workshop is to understand how to access and analyze ``Big Data'' associated with safety information in the health care setting, and the utility and challenges associated with the use of ``Big Data'' to study the safety of therapeutics in children.

The Food and Drug Administration (FDA or the Agency) announces a forthcoming public advisory committee meeting of the Pediatric Advisory Committee (PAC). 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. FDA is establishing a docket for public comments.

The Food and Drug Administration (FDA or we) is correcting a notice that appeared in the Federal Register of Wednesday, July 26, 2017 (82 FR 34615). The document announced that we have filed a petition, submitted by the Juice Products Association, proposing that the food additive regulations be amended to replace the current Recommended Daily Intake (RDI) percentage values of calcium in fruit juices and fruit juice drinks in the regulation for vitamin D3 with absolute values and to update the specifications for vitamin D3. The document was published with incorrect information on the absolute level of added calcium for fruit juice drinks that are fortified with calcium. This document corrects that error.

The Food and Drug Administration (FDA or the Agency) 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 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 Medical Monitoring Project, which collects interview and medical record data on a probability sample of HIV-diagnosed persons in order to provide national estimates of access to and utilization of HIV-related medical care and services, the quality of HIV-related ambulatory care, and HIV- related behaviors and clinical outcomes.