45 CFR Parts 160 & 164 (CFR Annual Edition) Title 45 Public Welfare Parts 1 to 139 Revised as of October 1, 2024 Containing a codification of documents of general applicability and future effect As of October 1, 2024 Published by the Office of the Federal National Archives and Records Administration as a Special Edition of the Federal Register U.S. GOVERNMENT OFFICIAL EDITION NOTICE Legal Status and Use of Seals and Logos The seal of the National Archives and Records Administration (NARA) authenticates the Code of Federal Regulations (CFR) as the official codification of Federal regulations established under the Federal Register Act. Under the provisions of 44 U.S.C. 1507, the contents of the CFR, a special edition of the Federal Register, shall be judicially noticed. The CFR is prima facie evidence of the origi- nal documents published in the Federal Register (44 U.S.C. 1510). 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The Superintendent of Documents of the U.S. Govern- ment Publishing Office requests that any reprinted edition clearly be labeled as a copy of the authentic work with a new ISBN. U . S . G O V E R N M E N T P U B L I S H I N G O F F I C E U.S. Superintendent of Documents • Washington, DC 20402–0001 http://bookstore.gpo.gov Phone: toll-free (866) 512-1800; DC area (202) 512-1800 Table of Contents Explanation ................................................................................................ Page v Title 45: SUBTITLE A—DEPARTMENT OF HEALTH AND HUMAN SERVICES ....... 3 Finding Aids: Table of CFR Titles and Chapters ....................................................... 833 Al ............ Page v Title 45: SUBTITLE A—DEPARTMENT OF HEALTH AND HUMAN SERVICES ....... 3 Finding Aids: Table of CFR Titles and Chapters ....................................................... 833 Alphabetical List of Agencies Appearing in the CFR ......................... 853 List of CFR Sections Affected ............................................................. 863 iii Cite this Code: CFR To cite the regulations in this volume use title, part and section num- ber. Thus, 45 CFR 2.1 refers to title 45, part 2, section 1. iv Explanation The Code of Federal Regulations is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agen- cies of the Federal Government. The Code is divided into 50 titles which represent broad areas subject to Federal regulation. Each title is divided into chapters which usually bear the name of the issuing agency. Each chapter is further sub- divided into parts covering specific regulatory areas. Each volume of the Code is revised at least once each calendar year and issued on a quarterly basis approximately as follows: Title 1 through Title 16................................................ . Each volume of the Code is revised at least once each calendar year and issued on a quarterly basis approximately as follows: Title 1 through Title 16..............................................................as of January 1 Title 17 through Title 27 .................................................................as of April 1 Title 28 through Title 41 ..................................................................as of July 1 Title 42 through Title 50 .............................................................as of October 1 The appropriate revision date is printed on the cover of each volume. LEGAL STATUS The contents of the Federal Register are required to be judicially noticed (44 U.S.C. 1507). The Code of Federal Regulations is prima facie evidence of the text of the original documents (44 U.S.C. 1510). HOW TO USE THE CODE OF FEDERAL REGULATIONS The Code of Federal Regulations is kept up to date by the individual issues of the Federal Register. These two publications must be used together to deter- mine the latest version of any given rule. To determine whether a Code volume has been amended since its revision date (in this case, October 1, 2024), consult the ‘‘List st be used together to deter- mine the latest version of any given rule. To determine whether a Code volume has been amended since its revision date (in this case, October 1, 2024), consult the ‘‘List of CFR Sections Affected (LSA),’’ which is issued monthly, and the ‘‘Cumulative List of Parts Affected,’’ which appears in the Reader Aids section of the daily Federal Register. These two lists will identify the Federal Register page number of the latest amendment of any given rule. EFFECTIVE AND EXPIRATION DATES Each volume of the Code contains amendments published in the Federal Reg- ister since the last revision of that volume of the Code. Source citations for the regulations are referred to by volume number and page number of the Federal Register and date of publication. Publication dates and effective dates are usu- ally not the same and care must be exercised by the user in determining the actual effective date. In instances where the effective date is beyond the cut- off date for the Code a note has been inserted to reflect the future effective date. In those instances where a regulation published in the Federal Register states a date certain for expiration, an appropriate note he Code a note has been inserted to reflect the future effective date. In those instances where a regulation published in the Federal Register states a date certain for expiration, an appropriate note will be inserted following the text. OMB CONTROL NUMBERS The Paperwork Reduction Act of 1980 (Pub. L. 96–511) requires Federal agencies to display an OMB control number with their information collection request. v Many agencies have begun publishing numerous OMB control numbers as amend- ments to existing regulations in the CFR. These OMB numbers are placed as close as possible to the applicable recordkeeping or reporting requirements. PAST PROVISIONS OF THE CODE Provisions of the Code that are no longer in force and effect as of the revision date stated on the cover of each volume are not carried. Code users may find the text of provisions in effect on any given date in the past by using the appro- priate List of CFR Sections Affected (LSA). For the convenience of the reader, a ‘‘List of CFR Sections Affected’’ is published at the end of each CFR volume. For changes to the Code prior to the LSA listings at the end of the volume, consult previous annual editions of the LSA. For change CFR Sections Affected’’ is published at the end of each CFR volume. For changes to the Code prior to the LSA listings at the end of the volume, consult previous annual editions of the LSA. For changes to the Code prior to 2001, consult the List of CFR Sections Affected compilations, published for 1949- 1963, 1964-1972, 1973-1985, and 1986-2000. ‘‘[RESERVED]’’ TERMINOLOGY The term ‘‘[Reserved]’’ is used as a place holder within the Code of Federal Regulations. An agency may add regulatory information at a ‘‘[Reserved]’’ loca- tion at any time. Occasionally ‘‘[Reserved]’’ is used editorially to indicate that a portion of the CFR was left vacant and not dropped in error. INCORPORATION BY REFERENCE What is incorporation by reference? Incorporation by reference was established by statute and allows Federal agencies to meet the requirement to publish regu- lations in the Federal Register by referring to materials already published else- where. For an incorporation to be valid, the Director of the Federal Register must approve it. The legal effect of incorporation by reference is that the mate- rial is treated as if it were published in full in the Federal Register (5 U.S.C. 552(a)). Thi of the Federal Register must approve it. The legal effect of incorporation by reference is that the mate- rial is treated as if it were published in full in the Federal Register (5 U.S.C. 552(a)). This material, like any other properly issued regulation, has the force of law. What is a proper incorporation by reference? The Director of the Federal Register will approve an incorporation by reference only when the requirements of 1 CFR part 51 are met. Some of the elements on which approval is based are: (a) The incorporation will substantially reduce the volume of material pub- lished in the Federal Register. (b) The matter incorporated is in fact available to the extent necessary to afford fairness and uniformity in the administrative process. (c) The incorporating document is drafted and submitted for publication in accordance with 1 CFR part 51. What if the material incorporated by reference cannot be found? If you have any problem locating or obtaining a copy of material listed as an approved incorpora- tion by reference, please contact the agency that issued the regulation containing that incorporation. If, after contacting the agency, you find the material is not available, pl n approved incorpora- tion by reference, please contact the agency that issued the regulation containing that incorporation. If, after contacting the agency, you find the material is not available, please notify the Director of the Federal Register, National Archives and Records Administration, 8601 Adelphi Road, College Park, MD 20740-6001, or call 202-741-6010. CFR INDEXES AND TABULAR GUIDES A subject index to the Code of Federal Regulations is contained in a separate volume, revised annually as of January 1, entitled CFR INDEX AND FINDING AIDS. This volume contains the Parallel Table of Authorities and Rules. A list of CFR titles, chapters, subchapters, and parts and an alphabetical list of agencies pub- lishing in the CFR are also included in this volume. An index to the text of ‘‘Title 3—The President’’ is carried within that volume. vi The Federal Register Index is issued monthly in cumulative form. This index is based on a consolidation of the ‘‘Contents’’ entries in the daily Federal Reg- ister. A List of CFR Sections Affected (LSA) is published monthly, keyed to the revision dates of the 50 CFR titles. REPUBLICATION OF MATERIAL There are no restrictions on the republicatio ederal Reg- ister. A List of CFR Sections Affected (LSA) is published monthly, keyed to the revision dates of the 50 CFR titles. REPUBLICATION OF MATERIAL There are no restrictions on the republication of material appearing in the Code of Federal Regulations. INQUIRIES For a legal interpretation or explanation of any regulation in this volume, contact the issuing agency. The issuing agency’s name appears at the top of odd-numbered pages. For inquiries concerning CFR reference assistance, call 202–741–6000 or write to the Director, Office of the Federal Register, National Archives and Records Administration, 8601 Adelphi Road, College Park, MD 20740-6001 or e-mail fedreg.info@nara.gov. SALES The Government Publishing Office (GPO) processes all sales and distribution of the CFR. For payment by credit card, call toll-free, 866-512-1800, or DC area, 202-512-1800, M-F 8 a.m. to 4 p.m. e.s.t. or fax your order to 202-512-2104, 24 hours a day. For payment by check, write to: US Government Publishing Office – New Orders, P.O. Box 979050, St. Louis, MO 63197-9000. ELECTRONIC SERVICES The full text of the Code of Federal Regulations, the LSA (List of CFR Sections Affected), The United States lishing Office – New Orders, P.O. Box 979050, St. Louis, MO 63197-9000. ELECTRONIC SERVICES The full text of the Code of Federal Regulations, the LSA (List of CFR Sections Affected), The United States Government Manual, the Federal Register, Public Laws, Public Papers of the Presidents of the United States, Compilation of Presi- dential Documents and the Privacy Act Compilation are available in electronic format via www.govinfo.gov. For more information, contact the GPO Customer Contact Center, U.S. Government Publishing Office. Phone 202-512-1800, or 866- 512-1800 (toll-free). E-mail, ContactCenter@gpo.gov. The Office of the Federal Register also offers a free service on the National Archives and Records Administration’s (NARA) website for public law numbers, Federal Register finding aids, and related information. Connect to NARA’s website at www.archives.gov/federal-register. The eCFR is a regularly updated, unofficial editorial compilation of CFR mate- rial and Federal Register amendments, produced by the Office of the Federal Register and the Government Publishing Office. It is available at www.ecfr.gov. OLIVER A. POTTS, Director, Office of the Federal Register October 1, 2024 dments, produced by the Office of the Federal Register and the Government Publishing Office. It is available at www.ecfr.gov. OLIVER A. POTTS, Director, Office of the Federal Register October 1, 2024 vii THIS TITLE Title 45—PUBLIC WELFARE is composed of five volumes. The parts in these vol- umes are arranged in the following order: Parts 1–139, 140–199, 200–499, 500–1199, and 1200 to end. Volumes one and two (parts 1–139 and parts 140–199) contain all current regulations issued under Subtitle A—Department of Health and Human Services. Volumes three through five contain all current regulations issued under Subtitle B—Regulations Relating to Public Welfare. Volume three (parts 200–499) contains all current regulations issued under Chapter II—Office of Family Assist- ance (Assistance Programs), Administration for Children and Families, Depart- ment of Health and Human Services, Chapter III—Office of Child Support Serv- ices, Administration of Families and Services, Department of Health and Human Services, and Chapter IV—Office of Refugee Resettlement, Administration for Children and Families, Department of Health and Human Services. Volume four (parts 500–1199) contains all current re d Human Services, and Chapter IV—Office of Refugee Resettlement, Administration for Children and Families, Department of Health and Human Services. Volume four (parts 500–1199) contains all current regulations issued under Chapter V—Foreign Claims Settlement Commission of the United States, Department of Justice, Chapter VI—National Science Foundation, Chapter VII—Commission on Civil Rights, Chapter VIII—Office of Personnel Management, Chapter IX—Denali Com- mission, Chapter X—Office of Community Services, Administration for Children and Families, Department of Health and Human Services, and Chapter XI—Na- tional Foundation on the Arts and the Humanities. Volume five (part 1200 to end) contains all current regulations issued under Chapter XII—Corporation for National and Community Service, Chapter XIII—Administration for Children and Families, Department of Health and Human Services, Chapter XVI—Legal Serv- ices Corporation, Chapter XVII—National Commission on Libraries and Informa- tion Science, Chapter XVIII—Harry S. Truman Scholarship Foundation, Chapter XXI—Commission of Fine Arts, Chapter XXIII—Arctic Research Commission, Chapter XXIV—James Madison Memorial Fellowship Foundati on Science, Chapter XVIII—Harry S. Truman Scholarship Foundation, Chapter XXI—Commission of Fine Arts, Chapter XXIII—Arctic Research Commission, Chapter XXIV—James Madison Memorial Fellowship Foundation, and Chapter XXV—Corporation for National and Community Service. The contents of these volumes represent all of the current regulations codified under this title of the CFR as of October 1, 2024. For this volume, Ann Worley was Chief Editor. The Code of Federal Regula- tions publication program is under the direction of John Hyrum Martinez, as- sisted by Stephen J. Frattini. ix Title 45—Public Welfare (This book contains parts 1 to 139) SUBTITLE A—DEPARTMENT OF HEALTH AND HUMAN SERV- ICES ..................................................................................... Part 2 1 SUBTITLE A—Department of Health and Human Services EDITORIAL NOTE: Nomenclature changes to subtitle A appear at 66 FR 39452, July 31, 2001. SUBCHAPTER A—GENERAL ADMINISTRATION Part 1 2 3 4 5 5a 5b 6 7 9 12 12a 13 15 16 17 18 30 31 32 33 34 [Reserved] Testimony by employees and production of docu- ments in proceedings where the United States is not a party .................................................. a 13 15 16 17 18 30 31 32 33 34 [Reserved] Testimony by employees and production of docu- ments in proceedings where the United States is not a party ........................................................... Conduct of persons and traffic on the National In- stitutes of Health Federal enclave ....................... Service of process .................................................... Freedom of Information regulations ....................... [Reserved] Privacy Act regulations .......................................... [Reserved] Employee inventions ............................................... Use of HHS research facilities by academic sci- entists, engineers, and students ........................... Disposal and utilization of surplus real property for public health purposes .................................... Use of Federal real property to assist the homeless Implementation of the Equal Access to Justice Act in agency proceedings .......................................... Uniform relocation assistance and real property acquisition for Federal and federally assisted programs .............................................................. Procedures of the Departmental Gran iform relocation assistance and real property acquisition for Federal and federally assisted programs .............................................................. Procedures of the Departmental Grant Appeals Board .................................................................... Release of adverse information to news media ....... Official symbol, logo, and seal ................................ Claims collection .................................................... Tax refund offset ..................................................... Administrative wage garnishment .......................... Salary offset ............................................................ Claims filed under the Military Personnel and Ci- vilian Employees Act ........................................... Page 7 10 16 17 34 48 50 51 58 67 76 76 85 86 87 106 109 115 124 3 Part 35 36 46 50 51 57 60 63 73 73a 73b 74 75 77 78 79 80 81 83 84 85 86 87 88 45 CFR Subtitle A (10–1–24 Edition) Tort claims against the Government ...................... Indemnification of HHS employees ......................... Protection of human subjects ................................. U.S. Exchange Visitor Program—request for w Government ...................... Indemnification of HHS employees ......................... Protection of human subjects ................................. U.S. Exchange Visitor Program—request for waiv- er of the two-year foreign residence requirement Criteria for evaluating comprehensive plan to re- duce reliance on alien physicians ......................... Volunteer services ................................................... National Practitioner Data Bank ........................... Grant programs administered by the Office of the Assistant Secretary for Planning and Evaluation Standards of conduct .............................................. Standards of conduct: Food and Drug Administra- tion supplement ................................................... Debarment or suspension of former employees ....... [Reserved] Uniform administrative requirements, cost prin- ciples, and audit requirements for HHS awards ... Remedial actions applicable to letter of credit ad- ministration ......................................................... Conditions for waiver of denial of Federal benefits Program fraud civil remedies .................................. Nondiscrimination under n ......................................................... Conditions for waiver of denial of Federal benefits Program fraud civil remedies .................................. Nondiscrimination under programs receiving Fed- eral assistance through the Department of Health and Human Services effectuation of Title VI of the Civil Rights Act of 1964 ......................... Practice and procedure for hearings under part 80 of this title ........................................................... Regulation for the administration and enforce- ment of sections 799A and 845 of the Public Health Service Act ............................................... Nondiscrimination on the basis of disability in pro- grams or activities receiving Federal financial assistance ............................................................. Enforcement of nondiscrimination on the basis of handicap in programs or activities conducted by the Department of Health and Human Services ... Nondiscrimination on the basis of sex in education programs or activities receiving Federal finan- cial assistance ...................................................... Equal treatment for faith-based organizations ....... basis of sex in education programs or activities receiving Federal finan- cial assistance ...................................................... Equal treatment for faith-based organizations ....... Ensuring that Department of Health and Human Services funds do not support coercive or disciminatory policies or practices in violation of Federal law ....................................................... Page 128 131 132 159 163 165 165 186 194 227 232 234 403 405 406 422 447 458 463 518 535 554 559 4 Dept. of Health and Human Services Part 89 90 91 92 93 94 95 96 97 98 99 100 101 102 Organizational integrity of entities implementing programs and activities under the Leadership Act ....................................................................... Nondiscrimination on the basis of age in programs or activities receiving Federal financial assist- ance ...................................................................... Nondiscrimination on the basis of age in programs or activities receiving Federal financial assist- ance from HHS ..................................................... Nondiscrimination in health programs or activities New restrictions on lobbying .............. s receiving Federal financial assist- ance from HHS ..................................................... Nondiscrimination in health programs or activities New restrictions on lobbying .................................. Responsible prospective contractors ....................... General administration—grant programs (public assistance, medical assistance and State chil- dren’s health insurance programs) ....................... Block grants ............................................................ Consolidation of grants to the insular areas ........... Child care and development fund ............................ Procedure for hearings for the child care and devel- opment fund ......................................................... Intergovernmental review of Department of Health and Human Services programs and activities ...... Health resources priorities and allocations system (HRPAS) ............................................................... Adjustment of civil monetary penalties for infla- tion ....................................................................... Page 562 563 571 579 596 607 616 638 696 697 759 764 767 784 5 SUBCHAPTER A—GENERAL ADMINISTRATION PART nalties for infla- tion ....................................................................... Page 562 563 571 579 596 607 616 638 696 697 759 764 767 784 5 SUBCHAPTER A—GENERAL ADMINISTRATION PART 1 [RESERVED] PART 2—TESTIMONY BY EMPLOYEES AND PRODUCTION OF DOCU- MENTS IN PROCEEDINGS WHERE THE UNITED STATES IS NOT A PARTY Sec. 2.1 Scope, purpose, and applicability. 2.2 Definitions. 2.3 Policy on presentation of testimony and production of documents. 2.4 Procedures when voluntary testimony is requested or when an employee is sub- poenaed. 2.5 Subpoenas duces tecum. 2.6 Certification and authentication of records. AUTHORITY: 5 U.S.C. 301, 5 U.S.C. 552. SOURCE: 52 FR 37146, Oct. 5, 1987, unless otherwise noted. tion, to follow all applicable procedural and substantive rules relating to the production of information, data, and records by a non-party. The avail- ability of Department employees to testify in litigation not involving fed- eral parties is governed by the Depart- ment’s policy to maintain strict impar- tiality with respect to private litigants and to minimize the disruption of offi- cial duties. (c) This part applies to state, local and tribal judicial, administrative, a cy to maintain strict impar- tiality with respect to private litigants and to minimize the disruption of offi- cial duties. (c) This part applies to state, local and tribal judicial, administrative, and legislative proceedings, and to federal judicial pro- ceedings. administrative and (d) This part does not apply to: (1) Any civil or criminal proceedings where the United States, the Depart- ment of Health and Human Services, and any agency thereof, or any other Federal agency is a party. (2) Congressional requests or sub- § 2.1 Scope, purpose, and applicability. poenas for testimony or documents. (a) This part sets forth rules to be followed when an employee or former employee of the Department of Health and Human Services (‘‘DHHS’’ or ‘‘De- partment’’), other than an employee of the Food and Drug Administration, is requested or subpoenaed to provide tes- timony in a deposition, trial, or other similar proceeding concerning informa- tion acquired in the course of per- forming official duties or because of such person’s official capacity with DHHS. This part also sets forth proce- dures for the handling of subpoenas duces tecum and other requests for any document in the possession o duties or because of such person’s official capacity with DHHS. This part also sets forth proce- dures for the handling of subpoenas duces tecum and other requests for any document in the possession of DHHS, other than the Food and Drug Adminis- tration, and for the processing of re- quests for certification of copies of doc- uments. Separate regulations, 21 CFR part 20, govern the Food and Drug Ad- ministration, and those regulations are not affected by this part. (b) It is the policy of the DHHS to provide information, data, and records to non-federal litigants to the same ex- tent and in the same manner that they are made available to the general pub- lic and, when subject to the jurisdic- tion of a court or other tribunal pre- siding over non-federal party litiga- (3) Consultative services and tech- nical assistance provided by the De- partment of Health and Human Serv- ices, or any agency thereof, in carrying out its normal program activities. (4) Employees serving as expert wit- nesses in connection with professional and consultative services as approved outside activities in accordance with 5 CFR 2635.805 and 5 CFR 5501.106. (In cases where employees are providing such outsi nesses in connection with professional and consultative services as approved outside activities in accordance with 5 CFR 2635.805 and 5 CFR 5501.106. (In cases where employees are providing such outside services, they must state for the record that the testimony rep- resents their own views and does not necessarily represent the official posi- tion of the DHHS.) (5) Employees making appearances in their private capacity in legal or ad- ministrative proceedings that do not relate to the Department of Health and Human Services (such as cases arising out of traffic accidents, crimes, domes- tic relations, etc.) and not involving professional and consultative services. (6) Any matters covered in 21 CFR part 20-,involving the Food and Drug Administration. (7) Any civil or criminal proceedings in State court brought on behalf of the Department of Health and Human Services. 7 § 2.2 45 CFR Subtitle A (10–1–24 Edition) Example (1): While on duty, an employee of the Department witnesses an incident in which a fellow employee trips on a loose piece of carpeting and sustains an injury. The injured employee brings a private tort action against the contractor installing the carpeting and the pri ent in which a fellow employee trips on a loose piece of carpeting and sustains an injury. The injured employee brings a private tort action against the contractor installing the carpeting and the private landlord maintain- ing the building. The employee/witness is served with a subpoena to appear at a deposi- tion to testify about the incident. The per- son seeking the testimony would not be re- quired to obtain Agency head approval prior to requesting the testimony, because the subject of the testimony does not ‘‘relate to’’ the Department, within the meaning of § 2.1(d)(5). Example (2): While on duty, an employee of the Department witnesses a mugging while looking out the window to check the weath- er, and then notifies the local police of what she observed. She is subsequently subpoe- naed to testify in a criminal proceeding. The local prosecutor would not be required to ob- tain Agency head approval prior to requiring the employee to testify, because the subject of the testimony does not ‘‘relate to’’ the De- partment, within the meaning of § 2.1(d)(5). Example (3): A nurse on duty at an Indian Health Service hospital emergency room treats a child who is brought in following a oes not ‘‘relate to’’ the De- partment, within the meaning of § 2.1(d)(5). Example (3): A nurse on duty at an Indian Health Service hospital emergency room treats a child who is brought in following a report of domestic violence. The nurse is subsequently served with a subpoena to tes- tify in a criminal proceeding against one of the child’s parents concerning the injuries to the child which he observed. The local pros- ecutor would be required to obtain Agency head approval prior to requiring the nurse to testify, because the subject of the testimony involves ‘‘information acquired in the course of performing official duties or because of the person’s official capacity,’’ within the meaning of § 2.1(a). Example (4): A personnel specialist working for the Department is subpoenaed to testify concerning the meaning of entries on time and attendance records of an employee, which the requesting party received from the employee pursuant to discovery in a personal injury action brought by the employee. The party requesting the personnel specialist to appear would be required to obtain Agency head approval prior to compelling the per- sonnel specialist to testify, because the tes- timony e employee. The party requesting the personnel specialist to appear would be required to obtain Agency head approval prior to compelling the per- sonnel specialist to testify, because the tes- timony sought involves ‘‘information ac- quired in the course of performing official duties or because of the person’s official ca- pacity,’’ within the meaning of § 2.1(a). Example (5): A National Institutes of Health physician is subpoenaed in a private medical malpractice action to provide expert testimony in her specialty. The party re- questing her testimony would be required to obtain Agency head approval prior to her testifying in response to the subpoena, be- cause the expert testimony sought involves ‘‘information acquired in the course of per- forming official duties or because of the per- son’s official capacity,’’ within the meaning of § 2.1(a). [52 FR 37146, Oct. 5, 1987, as amended at 55 FR 4611, Feb. 9, 1990; 68 FR 25838, May 14, 2003] § 2.2 Definitions. Agency head refers to the head of the relevant operating division or other major component of the DHHS, or his or her delegatee. Agency head for the purposes of this part means the following officials for the components indicat ead of the relevant operating division or other major component of the DHHS, or his or her delegatee. Agency head for the purposes of this part means the following officials for the components indicated: (1) Office of the Secretary—Assistant Secretary for Administration and Man- agement; (2) Administration on Aging—Assist- ant Secretary for Aging; (3) Administration for Children and Families—Assistant Secretary for Chil- dren and Families; (4) Agency for Healthcare Research and Quality—Administrator; (5) Agency for Toxic Substances and Disease Registry—Administrator; (6) Centers for Disease Control and Prevention—Director; (7) Centers for Medicare and Medicaid Services—Administrator; (8) Health Resources and Services Ad- ministration—Administrator; (9) Indian Health Service—Director; (10) National Institutes of Health— Director; (11) Substance Abuse and Mental Health Services Administration—Ad- ministrator; (12) Office of Inspector General—In- spector General. Employee of the Department includes current and former: (1) Commissioned officers in the Pub- lic Health Service Commissioned Corps, as well as regular and special DHHS employees (except employees of the Food and Drug Adminis t includes current and former: (1) Commissioned officers in the Pub- lic Health Service Commissioned Corps, as well as regular and special DHHS employees (except employees of the Food and Drug Administration), when they are performing the duties of their regular positions, as well as when they are performing duties in a tem- porary assignment at DHHS or another organization. (2) Employees of intermediaries, car- riers, Medicare Administrative Con- tractors, Program Safeguard Contrac- tors, and Recovery Audit Contractors, and any successor entities, that per- form one or more of the following func- tions described in section 1874A or 1893 of the Social Security Act relating to 8 Dept. of Health and Human Services § 2.4 the administration of the Medicare program: of (i) Determination payment amounts; making payments; bene- ficiary education and assistance; pro- viding consultative services; commu- nication with providers; or, provider education and technical assistance; or, (ii) Other such functions as are nec- essary to carry out the Medicare pro- gram, including any of the following program integrity functions under sec- tion 1893 of the Social Security Act: (A) Review of activitie ch functions as are nec- essary to carry out the Medicare pro- gram, including any of the following program integrity functions under sec- tion 1893 of the Social Security Act: (A) Review of activities of providers or suppliers, including medical and uti- lization review and fraud review; (B) Auditing of cost reports; (C) Determinations as to whether payment should not be, or should not have been, made because Medicare is the secondary payer, and recovery of payments that should not have been made; (D) Education of providers, bene- ficiaries, and other persons with re- spect to payment integrity and benefit quality assurance issues; or, (E) Developing (and periodically up- dating) a list of items of durable med- ical equipment which are subject to prior authorization. (3) Employees of a contractor, sub- contractor, or state agency performing survey, certification, or enforcement functions under title XVIII of the So- cial Security Act or Section 353 of the Public Health Service Act but only to the extent the requested information was acquired in the course of per- forming those functions and regardless of whether documents are also relevant to the state’s activities. (4) Employees only to the extent the requested information was acquired in the course of per- forming those functions and regardless of whether documents are also relevant to the state’s activities. (4) Employees and qualified contrac- tors of an entity covered under the Federally Supported Health Centers Assistance Act of 1992, as amended, 42 U.S.C. 233(g)–(n), (FSHCAA), provided that the testimony is requested in medical malpractice tort litigation and relates to the performance of medical, surgical, dental or related functions which were performed by the entity, its employees and qualified contractors at a time when the DHHS deemed the en- tity and its employees and qualified contractors to be covered by the FSHCAA. 9 Certify means to authenticate under seal, pursuant to 42 U.S.C 3505, official documents of the Department. Testify and testimony includes both in- person, oral statements before a court, legislative or administrative body and statements made pursuant to deposi- tions, interrogatories, declarations, af- fidavits, or other formal participation. [68 FR 25839, May 14, 2003, as amended at 73 FR 53150, Sept. 15, 2008] § 2.3 Policy on Presentation of testi- mony and production of docu es, declarations, af- fidavits, or other formal participation. [68 FR 25839, May 14, 2003, as amended at 73 FR 53150, Sept. 15, 2008] § 2.3 Policy on Presentation of testi- mony and production of documents. No employee or former employee of the DHHS may provide testimony or produce documents in any proceedings to which this part applies concerning information acquired in the course of performing official duties or because of the person’s official relationship with the Department unless authorized by the Agency head pursuant to this part based on a determination by the Agen- cy head, after consultation with the Of- fice of the General Counsel, that com- pliance with the request would pro- mote the objectives of the Department. [68 FR 25839, May 14, 2003] § 2.4 Procedures when voluntary testi- mony is requested or when an em- ployee is subpoenaed. (a) All requests for testimony by an employee or former employee of the DHHS in his or her official capacity and not subject to the exceptions set forth in § 2.1(d) of this part must be ad- dressed to the Agency head in writing and must state the nature of the re- quested testimony, why the informa- tion sought is unavailable by any other m set forth in § 2.1(d) of this part must be ad- dressed to the Agency head in writing and must state the nature of the re- quested testimony, why the informa- tion sought is unavailable by any other means, and the reasons why the testi- mony would be in the interest of the DHHS or the federal government. (b) If the Agency head denies ap- proval to comply with a subpoena for testimony, or if the Agency head has not acted by the return date, the em- ployee will be directed to appear at the stated time and place, unless advised by the Office of the General Counsel that responding to the subpoena would be cir- cumstances as, for example, an in- stance where the subpoena was not val- idly issued or served, where the sub- poena has been withdrawn, or where discovery has been stayed), produce a inappropriate such (in § 2.5 45 CFR Subtitle A (10–1–24 Edition) copy of these regulations, and respect- fully decline to testify or produce any documents on the basis of these regula- tions. PART 3—CONDUCT OF PERSONS AND TRAFFIC ON THE NATIONAL INSTITUTES OF HEALTH FEDERAL ENCLAVE [68 FR 25840, May 14, 2003] § 2.5 Subpoenas duces tecum. (a) Whenever a subpoena duces tecum has been served upon a DH NDUCT OF PERSONS AND TRAFFIC ON THE NATIONAL INSTITUTES OF HEALTH FEDERAL ENCLAVE [68 FR 25840, May 14, 2003] § 2.5 Subpoenas duces tecum. (a) Whenever a subpoena duces tecum has been served upon a DHHS employee or former employee commanding the production of any record, such person shall refer the subpoena to the Office of the General Counsel (including re- gional chief counsels) for a determina- tion of the legal sufficiency of the sub- poena, whether the subpoena was prop- erly served, and whether the issuing court or other tribunal has jurisdiction over the Department.) If the General Counsel or his designee determines that the subpoena is legally sufficient, the subpoena was properly served, and the tribunal has jurisdiction, the terms of the subpoena shall be complied with unless affirmative action is taken by the Department to modify or quash the subpoena in accordance with Fed. R. Civ. P. 45 (c). (b) If a subpoena duces tecum served upon a DHHS employee or former em- ployee commanding the production of any record is determined by the Office of the General Counsel to be legally in- sufficient, improperly served, or from a tribunal not having jurisdiction, such subpoena shall manding the production of any record is determined by the Office of the General Counsel to be legally in- sufficient, improperly served, or from a tribunal not having jurisdiction, such subpoena shall be deemed a request for records under the Freedom of Informa- tion Act and shall be handled pursuant to the rules governing public disclosure established in 45 CFR part 5. [68 FR 25840, May 14, 2003] § 2.6 Certification and authentication of records. Upon request, DHHS agencies will certify, pursuant to 42 U.S.C. 3505, the authenticity of copies of records that are to be disclosed. Fees for copying and certification are set forth in 45 CFR 5.43. [68 FR 25840, May 14, 2003] Subpart A—General Sec. 3.1 Definitions. 3.2 Applicability. 3.3 Compliance. 3.4 False reports and reports of injury or damage. 3.5 Lost and found, and abandoned property. 3.6 Nondiscrimination. Subpart B—Traffic Regulations 3.21 Emergency vehicles. 3.22 Request for identification. 3.23 Parking. 3.24 Parking permits. 3.25 Servicing of vehicles. 3.26 Speed limit. 3.27 Bicycles. Subpart C—Facilities and Grounds 3.41 Admission to facilities or grounds. 3.42 Restricted activities. 3.43 Removal of property. 3.44 Solicitati Servicing of vehicles. 3.26 Speed limit. 3.27 Bicycles. Subpart C—Facilities and Grounds 3.41 Admission to facilities or grounds. 3.42 Restricted activities. 3.43 Removal of property. 3.44 Solicitation. Subpart D—Penalties 3.61 Penalties. AUTHORITY: 40 U.S.C. 318–318d. 486; Delega- tion of Authority, 33 FR 604. SOURCE: 55 FR 2068, Jan. 22, 1990, unless otherwise noted. Subpart A—General § 3.1 Definitions. Director means the Director or Acting Director of the National Institutes of Health (NIH), or other officer or em- ployee of NIH to whom the authority involved has been delegated. Enclave means, unless the context re- quires a different meaning, the area, containing about 318 acres, acquired by the United States in several parcels in the years 1935 through 1983, and any further future acquisitions, comprising the National Institutes of Health lo- cated in Montgomery County, Mary- land, over which the United States ac- quired exclusive jurisdiction under the Act of March 31, 1953, Chapter 158 (1953 Maryland Laws 311). 10 Dept. of Health and Human Services § 3.2 Police officer means a uniformed or non-uniformed police officer appointed under a delegation of authority to the Directo pter 158 (1953 Maryland Laws 311). 10 Dept. of Health and Human Services § 3.2 Police officer means a uniformed or non-uniformed police officer appointed under a delegation of authority to the Director under Title U.S. Public Law 107–296, Homeland Security Act of 2002; any other Federal law enforcement of- ficer; and any other person whose law enforcement services are secured by contract, or upon request or deputation from a State or local law enforcement agency. [55 FR 2068, Jan. 22, 1990, as amended at 85 FR 72910, Nov. 16, 2020] § 3.2 Applicability. (a) The regulations in this part apply to all areas in the enclave and to all persons on or within the enclave, ex- cept as otherwise provided. (b) The regulations in this part do not apply to occupants, their visitors, and other authorized persons in areas used as living quarters: (1) When specifically made inappli- cable, and (2) In the case of the following provi- sions: § 3.24 Parking permits; § 3.25 Servicing of vehicles; § 3.42 Hobbies and sports; and § 3.42(f) Smoking. (c) All regulations in this part are in addition to the provisions in the United States Code, including title 18 relating to crimes and criminal proce- dure, an bies and sports; and § 3.42(f) Smoking. (c) All regulations in this part are in addition to the provisions in the United States Code, including title 18 relating to crimes and criminal proce- dure, and title 21 relating to food and drugs, which apply: (1) Without regard to the place of the offense, or (2) To areas (such as the enclave) sub- ject to the ‘‘special maritime and terri- torial the United States,’’ as defined in Title 18 United States Code section 7. jurisdiction of (d) In accordance with the Assimila- tive Crimes Act (18 U.S.C. 13), whoever is found guilty of an offense which, al- though not made punishable by any act of Congress, nor any provision of these regulations, would be punishable if committed within the State of Mary- land, shall be guilty of a like offense and subject to a like punishment. In the event of an irreconcilable conflict between a provision of this part and a Maryland statute governing the iden- tical subject matter, this part shall control. (e) Federal criminal statutes which apply. The following Federal criminal statutes in the United States Code apply to Federal enclaves and else- where without regard to the place of the offense. This listing is l criminal statutes which apply. The following Federal criminal statutes in the United States Code apply to Federal enclaves and else- where without regard to the place of the offense. This listing is provided solely for the information of the public and is not all-inclusive. The omission of other Federal statutes does not mean that such other statutes do not apply. In any given situation, the cited statutory provisions and any amend- ments in effect when the alleged of- fense occurred shall determine the spe- cifics of the offense, applicability, and penalty. Subject U.S. Code Provides generally Maximum penalty 1. By force or threat of force, willful injury, inter- intimidation or ference with, or attempts to in- jure, intimidate or interfere with, a person from participating in or enjoying any benefit, service, privilege, program, facility, or ac- tivity, provided by or adminis- tered by the U.S., and engaging in certain other Federal pro- tected activities. 2. Malicious destruction or dam- age, by an explosive, to a build- ing or other property owned, possessed, used, or leased by the U.S., U.S. agency, or any or- ganization receiving Federal fi- nancial assistance. 3. Possessio or dam- age, by an explosive, to a build- ing or other property owned, possessed, used, or leased by the U.S., U.S. agency, or any or- ganization receiving Federal fi- nancial assistance. 3. Possession of explosive in buildings owned, possessed, used, or leased by U.S. or U.S. agency. 18 U.S.C. 245 ... Prohibits ........................................ Not involving death or bodily in- Imprisonment one year jury: and/or $1,000 fine. 18 U.S.C. 844(f) Prohibits ........................................ First offense not involving death or personal Imprisonment 10 years and/or $10,000 fine and seizure and forfeiture of ex- plosive materials. injury: 18 U.S.C. 844(g) Prohibits, except with written con- sent of the agency. Imprisonment one year and/or $1,000 fine and seizure and for- feiture of explosive materials. 11 § 3.2 45 CFR Subtitle A (10–1–24 Edition) Subject U.S. Code Provides generally Maximum penalty 4. Use of or carrying an explosive to commit, or during commission of, a felony prosecutable in a U.S. court. 5. Use of or carrying a firearm dur- ing and in relation to any crime of violence prosecutable in a U.S. court. 6. Manufacture, distribution, dis- pensing, or possession w rosecutable in a U.S. court. 5. Use of or carrying a firearm dur- ing and in relation to any crime of violence prosecutable in a U.S. court. 6. Manufacture, distribution, dis- pensing, or possession with in- tent to do these acts, of nar- cotics and other controlled sub- stances and counterfeit sub- stances. 7. Simple possession of narcotics or other controlled substances. 18 U.S.C. 844(h) Prohibits ........................................ First offense: Imprisonment 10 years and seizure and forfeiture of explosive materials. 18 U.S.C. 924(c) Prohibits ........................................ First offense: Imprisonment 5 years and $5,000 fine and sei- zure and forfeiture of firearm and ammunition. 21 U.S.C. 841, 842, 843, 845. Prohibits, except as authorized by the Controlled Substances Act (generally 21 U.S.C. 801–904). 21 U.S.C. 844 ... Prohibits, unless substance ob- tained directly, or pursuant to prescription or order, from a practitioner, acting in the course of professional practice, or as otherwise authorized under the Controlled Substances Act. First offense: Imprisonment 20 years and/or $250,000 fine de- pending on the amount and kind of substance (twice the above penalt ctice, or as otherwise authorized under the Controlled Substances Act. First offense: Imprisonment 20 years and/or $250,000 fine de- pending on the amount and kind of substance (twice the above penalties for distribution by a person at least 18 years of age to one under age 21). First offense: Imprisonment 1 year and/or $5,000 fine. (f) Maryland criminal statutes that apply. The matters described in this paragraph are governed, in whole or in part, by the current version of the cited Maryland criminal statutory pro- visions, which are made Federal crimi- nal offenses under the Assimilative Crimes Act (18 U.S.C. 13). This listing sets forth areas of conduct particularly relevant to the enclave and is provided solely for the information of the pub- lic. The list is not all-inclusive and omission of other Maryland criminal statutes does not mean that such other statutes are not assimilated as Federal offenses under the Act. Generally, other Maryland criminal statutes will apply on the enclave, by force of the Act, unless superseded by Federal Law or a given provision of this part. In any given situation, the cited statutory provisions and any amendments in ef- fect when the alleged of lave, by force of the Act, unless superseded by Federal Law or a given provision of this part. In any given situation, the cited statutory provisions and any amendments in ef- fect when the alleged offense occured shall determine the specifics of the of- fense, applicability, and penalty. Subject Maryland code annotated Provides generally Maximum penalty 1. Pedestrian right-of-way .............. Transportation, Sec. 21–502. Pedestrians have the right-of-way in crosswalks and certain other areas. Subject to certain limita- tions. Imprisonment 2 months and/or $500 fine. Sec. 21–511 ...... Blind, partially blind, or hearing impaired pedestrians have the right-of-way at any crossing or intersection. Subject to certain limitations. $500 fine. 2. Drivers to exercise due care ..... Transportation, Sec. 21–504. Drivers shall exercise due care to avoid colliding with pedestrians, children and incapacitated indi- viduals. $500 fine. 3. Driving while intoxicated, under the influence of alcohol and/or a drug or controlled substance. Transportation, Sec. 21–902. Prohibits ........................................ Sec. 21–902(a) (driving while in- toxicated, first offense): Impris- onment 1 year d/or a drug or controlled substance. Transportation, Sec. 21–902. Prohibits ........................................ Sec. 21–902(a) (driving while in- toxicated, first offense): Impris- onment 1 year and/or $1,000 fine. 4. Unattended motor vehicles ........ Transportation, Sec. 21–1101. Prohibits leaving motor vehicles unattended unless certain pre- cautions are taken. 5. Carrying or wearing certain con- cealed weapons than handguns) or openly with intent to injure. (other Sec. 4–202 ........ Prohibits, except for law enforce- ment personnel or as a reason- able precaution against appre- hended danger. 12 Sec. 21–902 (b), (c), (d) (driving under the influence): Imprison- ment 2 months and/or $500 fine. $500 fine. Imprisonment 3 years or $1,000 fine. Dept. of Health and Human Services § 3.21 Subject Maryland code annotated Provides generally Maximum penalty 6. Unlawful wearing, carrying, or transporting a handgun, whether concealed or openly. 7. Use of handgun or concealable antique firearm in commission of felony or crime of violence. Sec. 4–202 ........ Prohibits except by law enforce- ment personnel or with permit. Sec. 4–204 ........ Prohibits ................................... earm in commission of felony or crime of violence. Sec. 4–202 ........ Prohibits except by law enforce- ment personnel or with permit. Sec. 4–204 ........ Prohibits ........................................ First offense and no prior related offense: Imprisonment 3 years and/or $2,500 fine. Imprisonment 20 years. 8. Disturbance of the peace .......... Sec. 6–409 ........ Prohibits acting in a disorderly Imprisonment 30 days and/or manner in public places. $500 fine. 9. Gambling .................................... Sec. 12–102 ...... Prohibits betting, wagering and gambling, and certain games of chance (does not apply to vend- ing or purchasing lottery tickets authorized under State law in accordance with approved pro- cedures). Sec. 240: Imprisonment one year and/or $1,000 fine. Sec. 245: Imprisonment 2 years and/or $100 fine. [55 FR 2068, Jan. 22, 1990, as amended at 85 FR 72910, Nov. 16, 2020] § 3.3 Compliance. A person must comply with the regu- lations in this part; with all official signs; and with the lawful directions or orders of a police officer or other au- thorized person, including traffic and parking directions. § 3.4 False reports and reports of in- jury or damage. A p l signs; and with the lawful directions or orders of a police officer or other au- thorized person, including traffic and parking directions. § 3.4 False reports and reports of in- jury or damage. A person may not knowingly give any false or fictitious report con- cerning an accident or violation of the regulations of this part or any applica- ble Federal or Maryland statute to any person properly investigating an acci- dent or alleged violation. All incidents resulting in injury to persons or willful damage to property in excess of $100.00 (one hundred dollars) in value must be reported by the persons involved to the Police Office as soon as possible. [55 FR 2068, Jan. 22, 1990, as amended at 88 FR 1135, Jan. 9, 2023] § 3.5 Lost and found, and abandoned property. Lost articles which are found on the enclave, including money and other personal property, together with any identifying information, must be de- posited at the Police Office or with an office (such as the place where found) which may likely have some knowledge of ownership. If the article is deposited with an office other than the Police Of- fice and the owner does not claim it within 30 days, it shall be deposited at th which may likely have some knowledge of ownership. If the article is deposited with an office other than the Police Of- fice and the owner does not claim it within 30 days, it shall be deposited at the Police Office for further disposition in accordance with General Services Administration regulations (41 CFR 102). Abandoned, or other unclaimed property and, in the absence of specific direction by a court, forfeited property, may be so identified by the Police Of- fice and sold and the proceeds depos- ited in accordance with 41 CFR part 102–41. [57 FR 1874, Jan. 16, 1992, as amended at 85 FR 72910, Nov. 16, 2020] § 3.6 Nondiscrimination. A person may not discriminate by segregation or otherwise against an- other person because of age, color, creed, handicap, national origin, race or sex, in furnishing or by refusing to furnish to that person the use of any facility of a public nature, including all services, privileges, accommoda- tions, and activities provided within the enclave. (Title 18 United States Code section 245 prohibits, by use of force or threat of force, willful injury, intimidation, or interference with, a person from participating in or enjoy- ing any benefit, servic le 18 United States Code section 245 prohibits, by use of force or threat of force, willful injury, intimidation, or interference with, a person from participating in or enjoy- ing any benefit, service, privilege, pro- gram, facility, or activity provided by or administered by the United States, attempts to do these acts, and engag- ing in certain other activities.) Subpart B—Traffic Regulations § 3.21 Emergency vehicles. A person must yield the right of way to an emergency vehicle operating its siren or flashing lights. 13 § 3.22 45 CFR Subtitle A (10–1–24 Edition) § 3.22 Request for identification. Upon request by a police officer, a person involved in any of the following situations must provide identification, for example, by exhibiting satisfactory credentials (such as an employment identification card or driver’s license): (a) A traffic accident within the en- clave; (b) The police officer reasonably be- lieves that the individual is engaged in, or has engaged in, criminal conduct or a violation of the regulations of this part; or (c) The enclave or a portion of the en- clave is not open to the public (see § 3.41). A driver of a motor vehicle involved in an accident within th t or a violation of the regulations of this part; or (c) The enclave or a portion of the en- clave is not open to the public (see § 3.41). A driver of a motor vehicle involved in an accident within the enclave shall also exhibit, upon the request of a po- lice officer, the owner’s registration card or other satisfactory proof of own- ership. § 3.23 Parking. (a) A person may not stand (vehicle stopped, with or without, an occupant), or park a motor vehicle or other vehi- cle: (1) In a lane, space, or area not des- ignated by a sign for parking, and/or standing; (2) On a sidewalk; (3) Within an intersection or cross- walk; (4) Within 10 feet of a fire hydrant, 5 feet of a driveway, or 20 feet of a stop sign, crosswalk, or traffic control sig- nal; (5) In a double-parked position; (6) At a curb painted yellow; (7) On the side of a street facing on- coming traffic; (8) In a position that would obstruct traffic; (9) For a period in excess of 24 hours, except at living quarters, or with the approval of the Police Office. (b) A person must park bicycles, mo- torbikes, and similar vehicles only in designated areas, and may not bring these vehicles inside buildings. (c) A visitor must park approval of the Police Office. (b) A person must park bicycles, mo- torbikes, and similar vehicles only in designated areas, and may not bring these vehicles inside buildings. (c) A visitor must park in an area identified for that purpose by posted signs or similar instructions, such as ‘‘visitor parking’’ and ‘‘reserved for visitors’’. (d) A person may not drive or park an unauthorized motor vehicle on a grassy, or any other unpaved, area without the approval of the Police Of- fice. § 3.24 Parking permits. Except for visitor parking, a person may not park a motor vehicle without displaying a parking permit, currently valid for that location. The Director may revoke or refuse to issue or renew any parking permit for violation of this section, or any provision of this part. § 3.25 Servicing of vehicles. A person may not wash, polish, change oil, lubricate, or make non- emergency repairs on a privately owned vehicle. § 3.26 Speed limit. The speed limit is 25 miles per hour, unless otherwise posted. A driver of a vehicle may not exceed the speed limit. § 3.27 Bicycles. A person may not operate a bicycle, motorbike, or similar vehicle without a horn or other warning device, and, if the ise posted. A driver of a vehicle may not exceed the speed limit. § 3.27 Bicycles. A person may not operate a bicycle, motorbike, or similar vehicle without a horn or other warning device, and, if the vehicle is operated between dusk and dawn, it must be equipped with an operating headlight, and taillight or reflector. Subpart C—Facilities and Grounds § 3.41 Admission grounds. to facilities or The enclave is officially open to the public during normal working and vis- iting hours and for approved public events. The enclave is closed to the public at all other times, and the Di- rector may also officially close all or part of the enclave, or any building, in emergency situations and at other times the Director deems necessary to ensure the orderly conduct of Govern- ment business. When all or part of the enclave is closed to the public, admis- sion is restricted to employees and other authorized persons who may be required to display Government cre- dentials or other identification when requested by a police officer and may be required to sign a register. The liv- ing quarters and adjacent areas are not open to the public but are open at all times to occupants and their visitors 14 requested by a police officer and may be required to sign a register. The liv- ing quarters and adjacent areas are not open to the public but are open at all times to occupants and their visitors 14 Dept. of Health and Human Services § 3.43 and business invitees, unless otherwise closed by the Director. § 3.42 Restricted activities. (a) Hobbies and sports. A person may undertake hobbies and sports only in designated areas or as approved by the Director. (b) Pets and other animals. A person may not bring on the enclave any cat, dog, or other animal except for author- ized purposes. This prohibition does not apply to domestic pets at living quarters or to the exercise of these pets under leash or other appropriate re- straints. The use of a service animal by a person with a disability to assist that person is authorized. (c) Photography. A person may take photographs, films or audiovisuals, for personal or news purposes on the grounds of the enclave or in entrances, lobbies, foyers, corridors, and audito- riums in use for public meetings, ex- cept when contrary to security regula- tions or Department of Health and Human Services policies, or where pro- hibited by appropriate signs. ridors, and audito- riums in use for public meetings, ex- cept when contrary to security regula- tions or Department of Health and Human Services policies, or where pro- hibited by appropriate signs. Photo- graphs and similar activities for adver- tising or commercial purposes may be taken only with the advance written approval of the Director. A person may take photographs of a patient only with the informed consent of the pa- tient (or the natural or legal guardian) and of the Director of the Warren Grant Magnuson Clinical Center or del- egate. (d) Intoxicating beverages, narcotics, and other controlled substances. A person may not possess, sell, consume, or use alcohol or other intoxicating bev- erages, except in connection with offi- cial duties, as part of authorized re- search, or as otherwise authorized by the Director, or, in the case of posses- sion, consumption or use only, in living quarters. (The sale, consumption, use, or possession of narcotics and other controlled substances is prohibited and shall be governed by the Controlled Substances Act (21 U.S.C. 841–845); driv- ing under the influence of an alcoholic beverage, drug or controlled substance is prohibited and sh nces is prohibited and shall be governed by the Controlled Substances Act (21 U.S.C. 841–845); driv- ing under the influence of an alcoholic beverage, drug or controlled substance is prohibited and shall be governed by the Maryland Transportation Code An- notated section 21–902.) (e) Nuisances and disturbances. The following acts by a person are prohib- ited: Unwarranted loitering, disorderly conduct (acting in a disorderly manner to the disturbance of the public peace is prohibited and shall be governed by Maryland Code Annotated, Article 27, section 122); littering or disposal of rubbish in an unauthorized manner, the creation of any hazard to persons or property; the throwing of articles of any kind from or at a building; the climbing upon any part of a building for other than an authorized purpose; the loud playing of radios or other similar devices; and rollerskating, skateboarding, sledding or similar ac- tivities, except in officially designated areas. (f) Smoking. Except as part of an ap- proved medical research protocol, a person may not smoke on the enclave. (g) Firearms, explosive, and other weap- ons. No person other than a specifically authorized police officer shall p t of an ap- proved medical research protocol, a person may not smoke on the enclave. (g) Firearms, explosive, and other weap- ons. No person other than a specifically authorized police officer shall possess firearms, explosives, or other dan- gerous or deadly weapons or dangerous materials intended to be used as weap- ons either openly or concealed. Upon written request, the Director may per- mit possession in living quarters of an- tique firearms held for collection pur- poses, if the Director finds that the col- lection does not present any risk of harm. [55 FR 2068, Jan. 22, 1990, as amended at 57 FR 1874, Jan. 16, 1992; 88 FR 1135, Jan. 9, 2023] § 3.43 Removal of property. A person may not remove Federal property from the enclave or any build- ing on the enclave without a property pass, signed by an authorized property custodian, which specifically describes the items to be removed. In an emer- gency, or when the property custodian is not available, a police officer may approve removal of Federal property if, after consulting with the administra- tive officer or other appropriate offi- cial, the police officer is authorized by the official to do so. Privately-owned property, ot oval of Federal property if, after consulting with the administra- tive officer or other appropriate offi- cial, the police officer is authorized by the official to do so. Privately-owned property, other than that ordinarily carried on one’s person, may be re- moved only under this property pass procedure, or upon properly estab- lishing ownership of the property to a police officer. Packages, briefcases, or other con- tainers brought within the enclave are 15 § 3.44 45 CFR Subtitle A (10–1–24 Edition) subject to inspection while on, or being removed from, the enclave. § 3.44 Solicitation. It shall be unlawful for a person (other than an employee using author- ized bulletin boards), without prior written approval of the Director, to offer or display any article or service for sale within the enclave buildings or grounds; or to display any sign, placard, or other form of advertise- ment; or to collect private debts; or to solicit business, alms, subscriptions or contributions, except in connection with approved national or local cam- paigns for funds for welfare, health and other public interest purposes, or solic- itation of labor organization member- ship or dues as authorized und connection with approved national or local cam- paigns for funds for welfare, health and other public interest purposes, or solic- itation of labor organization member- ship or dues as authorized under the Civil Service Reform Act of 1978 (Pub. L. 95–454). This provision shall not apply to au- thorized lessees and their agents and employees with regard to space leased for commercial, cultural, educational, or recreational purposes, under the Public Buildings Cooperative Use Act of 1976 (40 U.S.C. 490(A)(16)). Subpart D—Penalties § 3.61 Penalties. (a) A person found guilty of violating any provision of the regulations in this part is subject to a fine or imprison- ment of not more than thirty days or both, for each violation (Pub. L. 107– 296, Homeland Security Act of 2002). (b) Penalties for violation of offenses proscribed by Federal statutes (gen- erally codified in title 18 of the United States Code) and Maryland criminal statutes which are made Federal of- fenses under the Assimilative Crimes Act and are prescribed in the applica- ble provisions of those statutes. [55 FR 2068, Jan. 22, 1990, as amended at 85 FR 72910, Nov. 16, 2020; 88 FR 1135, Jan. 9, 2023] PART 4—SERVICE OF ative Crimes Act and are prescribed in the applica- ble provisions of those statutes. [55 FR 2068, Jan. 22, 1990, as amended at 85 FR 72910, Nov. 16, 2020; 88 FR 1135, Jan. 9, 2023] PART 4—SERVICE OF PROCESS Sec. 4.1 Suits against the Department and its employees in their official capacities. 4.2 Other process directed to the Depart- ment or Secretary. 4.3 Process against Department officials in their individual capacities. 4.4 Acknowledgment of mailed process. 4.5 Effect of regulations. 4.6 Materials related to petitions under the National Vaccine Injury Compensation Program. 4.7 Congressional subpoenas directed to the Department or Secretary. AUTHORITY: 5 U.S.C. 301, 42 U.S.C. 300aa–11. SOURCE: 48 FR 24079, May 31, 1983, unless otherwise noted. § 4.1 Suits against the Department and its employees in their official capac- ities. Summonses and complaints to be served by mail on the Department of Health and Human Services, the Sec- retary of Health and Human Services, or other employees of the Department in their official capacities should be sent to the General Counsel, Depart- ment of Health and Human Services, 200 Independence Avenue, S.W., Wash- ington, DC 20201. § 4.2 Other pro of the Department in their official capacities should be sent to the General Counsel, Depart- ment of Health and Human Services, 200 Independence Avenue, S.W., Wash- ington, DC 20201. § 4.2 Other process directed to the De- partment or Secretary. Subpoenas and other process (other than summonses and complaints) that are required to be served on the De- partment of Health and Human Serv- ices or the Secretary of Health and Human Services in his official capacity should be served as follows: (a) If authorized by law to be served by mail, any mailed process should be sent to the General Counsel, Depart- ment of Health and Human Services, 200 Independence, S.W., Washington, DC 20201. (b) If served by an individual, the process should be delivered to the staff in the Office of Legal Resources, Office of the General Counsel, Room 700E, 200 Independence Avenue, SW., Wash- ington, DC 20201, or in the absence of that staff, to any staff member of or in- dividual assigned to the Immediate Of- fice of the General Counsel, up to and including any Deputy General Counsel. [48 FR 24079, May 31, 1983,as amended at 73 FR 48151, Aug. 18, 2008] § 4.3 Process against Department offi- cials in their i ice of the General Counsel, up to and including any Deputy General Counsel. [48 FR 24079, May 31, 1983,as amended at 73 FR 48151, Aug. 18, 2008] § 4.3 Process against Department offi- cials in their individual capacities. Process to be served on Department officials in their individual capacities must be served in compliance with the 16 Dept. of Health and Human Services Pt. 5 requirements for service of process on individuals who are not governmental officials. The Office of the General Counsel is authorized but not required to accept process to be served on De- partmental officials in their individual capacities if the suit relates to an em- ployee’s official duties. § 4.4 Acknowledgement of mailed proc- ess. The Department will not provide a receipt or other acknowledgement of process received, except for a return re- ceipt associated with certified mail and, where required, the acknowledge- ment specified by Rule 4(c)(2)(C) of the Federal Rules of Civil Procedure. § 4.5 Effect of regulations. The regulations in this part are in- tended solely to identify Department officials who are authorized to accept service of process. Litigants must com- ply with all requirements pertainin egulations. The regulations in this part are in- tended solely to identify Department officials who are authorized to accept service of process. Litigants must com- ply with all requirements pertaining to service of process that are established by statute and court rule even though they are not repeated in these regula- tions. § 4.6 Materials related to petitions under the National Vaccine Injury Compensation Program. Notwithstanding the provisions of §§ 4.1, 4.2, and 4.3, service of the Sec- retary’s copies of petitions for com- pensation under the VICP and of re- lated filings, by mail, shall be served upon the Director, Division of Vaccine Injury Compensation, Office of Special Programs, Health Resources and Serv- ices Administration 5600 Fishers Lane, Parklawn Building, Room 16C–17, Rockville, Maryland 20857, or in person, shall be served upon the Director, Divi- sion of Vaccine Injury Compensation, Office of Special Programs, Health Re- sources and Services Administration, 4350 East West Highway, 10th Floor, Bethesda, Maryland 20814. [67 FR 78990, Dec. 27, 2002] § 4.7 Congressional subpoenas directed to the Department or Secretary. Notwithstanding the provisions of §§ 4.1, 4.2 st West Highway, 10th Floor, Bethesda, Maryland 20814. [67 FR 78990, Dec. 27, 2002] § 4.7 Congressional subpoenas directed to the Department or Secretary. Notwithstanding the provisions of §§ 4.1, 4.2, and 4.3, service of Congres- sional subpoenas shall be delivered to the staff in the Office of the Assistant Secretary for Legislation, Department of Health and Human Services, 200 Independence Avenue, SW., Wash- ington, DC 20201. [73 FR 48151, Aug. 18, 2008] PART 5—FREEDOM OF INFORMATION REGULATIONS Subpart A—General Information About Freedom of Information Act Requests Sec. 5.1 Purpose. 5.2 Presumption of openness and proactive disclosures. 5.3 Definitions. 5.4 Regulatory scope. 5.5 Interrelationship between the FOIA and the Privacy Act of 1974. Subpart B—How to Request Records under FOIA 5.21 Who can file a FOIA request? 5.22 What do I include in my FOIA request? 5.23 Where do I send my FOIA request? 5.24 How does HHS process my FOIA re- quest? 5.25 How does HHS handle requests that in- volve more than one OpDiv, StaffDiv, or Federal agency? 5.26 How does HHS determine estimated completion dates for FOIA requests? 5.27 How do I request expedited processing? 5.28 How does HHS respo n- volve more than one OpDiv, StaffDiv, or Federal agency? 5.26 How does HHS determine estimated completion dates for FOIA requests? 5.27 How do I request expedited processing? 5.28 How does HHS respond to my request? 5.29 How may I request assistance with the FOIA process? Subpart C —Exemptions to Disclosure 5.31 What are the reasons records may be withheld? 5.32 Records not subject to the require- ments of the FOIA—law enforcement ex- clusions. Subpart D—Confidential Commercial Information 5.41 How does a submitter identify records containing confidential commercial in- formation? 5.42 How does HHS process FOIA requests for confidential commercial information? Subpart E—Fees 5.51 General information on fees for all FOIA requests. 5.52 What is the FOIA fee schedule for ob- taining records? 5.53 How does HHS calculate FOIA fees for different categories of requesters? 5.54 How may I request a fee waiver? 17 § 5.1 45 CFR Subtitle A (10–1–24 Edition) Subpart F—Appeals 5.61 When may I appeal HHS’s FOIA deter- mination? 5.62 How do I file an appeal? 5.63 How does HHS process appeals? 5.64 What avenues are available to me if I disagree with HHS’s appeal decision? Subpart G—Records Retent al HHS’s FOIA deter- mination? 5.62 How do I file an appeal? 5.63 How does HHS process appeals? 5.64 What avenues are available to me if I disagree with HHS’s appeal decision? Subpart G—Records Retention 5.71 How does HHS retain FOIA records? AUTHORITY: 5 U.S.C. 552, 18 U.S.C. 1905, 31 U.S.C. 9701, 42 U.S.C. 1306(c), E.O. 12600, E.O.13392 SOURCE: 81 FR 74939, Oct. 28, 2016, unless otherwise noted. Subpart A—General Information About Freedom of Information Act Requests § 5.1 Purpose. This part implements the provisions of the Freedom of Information Act (FOIA), 5 U.S.C. 552, as amended, for Department of Health and Human Services (HHS) records that are subject to the FOIA. This part should be read in conjunction with the text of the FOIA and the Uniform Freedom of In- formation Fee Schedule and Guidelines published by the Office of Management and Budget. This part contains the rules that we follow to process FOIA requests, such as the amount of time we have to make a determination re- garding the release of records, who can decide to release records and who can decide not to release them, the fees we may charge, if applicable, the reasons why some records are exempt from dis- closure rding the release of records, who can decide to release records and who can decide not to release them, the fees we may charge, if applicable, the reasons why some records are exempt from dis- closure under the FOIA, and the ad- ministrative and legal remedies avail- able should a requester disagree with our initial disclosure determination. (a) The FOIA provides a right of ac- cess to agency records, except to the extent that any portions of the records are protected from public disclosure by an exemption or exclusion in the stat- ute. The FOIA does not require us to perform research for you or to answer your questions. The FOIA does not re- quire agencies to create new records or to perform analysis of existing records; for example, by extrapolating informa- tion from existing agency records, re- formatting publicly available informa- tion, preparing new electronic pro- grams or databases, or creating data through calculations of ratios, propor- tions, percentages, trends, frequency distributions, correlations, or compari- sons. However, at our discretion and if it would conserve government re- sources, we may decide to supply re- quested information by consolidating information distributions, correlations, or compari- sons. However, at our discretion and if it would conserve government re- sources, we may decide to supply re- quested information by consolidating information from various records. (b) This part does not apply to data generated by an agency grant recipient under the provisions of 45 CFR part 75 to the extent the requirements of 45 CFR 75.322(e) do not apply to the data. We will not process your request under the FOIA or these regulations if that data is already available to the public through an archive or other source. In that situation, we will refer you to that other source. The procedures for requesting research data made avail- able under the provisions of 45 CFR 75.322(e) are referenced in § 5.23(a). § 5.2 Presumption of openness and proactive disclosures. (a) We will administer the FOIA with a presumption of openness. In accord- ance with 5 U.S.C. 552(a)(8) we will dis- close records or information exempt from disclosure under the FOIA when- ever disclosure would not foreseeably harm an interest protected by a FOIA exemption and disclosure is not prohib- ited by law. We also will consider whether partial disclosure of informa- tion is en- ever disclosure would not foreseeably harm an interest protected by a FOIA exemption and disclosure is not prohib- ited by law. We also will consider whether partial disclosure of informa- tion is possible whenever we determine that a full disclosure of a requested record is not possible. This includes taking reasonable steps to segregate and release nonexempt information. (b) Records that the FOIA requires agencies to make available for public inspection in an electronic format may be accessed through each OpDiv’s and Staff Div’s Web site. Each OpDiv and StaffDiv is responsible for determining which of its records must be made pub- licly available (including frequently re- quested records), for identifying addi- tional records of interest to the public that are appropriate for public disclo- sure, and for posting and indexing such records. Each OpDiv and StaffDiv must ensure that its Web site of posted records and indices is reviewed and up- dated on an ongoing basis. Each OpDiv and StaffDiv has a FOIA Requester Service Center or FOIA Public Liaison 18 Dept. of Health and Human Services § 5.3 who can assist individuals in locating records. A list of agency FOIA Public Liaisons nd StaffDiv has a FOIA Requester Service Center or FOIA Public Liaison 18 Dept. of Health and Human Services § 5.3 who can assist individuals in locating records. A list of agency FOIA Public Liaisons http:// www.foia.gov/report-makerequest.html. available at is § 5.3 Definitions. The following definitions apply to this part: Agency is defined at 5 U.S.C. 551(1). HHS is an agency. Private entities per- forming work under a contractual agreement with the government are not agencies for the purpose of this def- inition. However, information main- tained on behalf of an agency under Government contract, for the purposes of records management, is considered an agency record. Chief FOIA Officer means a senior of- ficial of HHS, at the Assistant Sec- retary or equivalent level, who has agency-wide responsibility for ensuring efficient and appropriate compliance with the FOIA, monitoring implemen- tation of the FOIA throughout the agency, and making recommendations to the head of the agency to improve the agency’s implementation of the FOIA. The Secretary of HHS has des- ignated the Assistant Secretary, Office of the Assistant Secretary for Public Affairs (ASPA), as the Agency Chief FOIA o improve the agency’s implementation of the FOIA. The Secretary of HHS has des- ignated the Assistant Secretary, Office of the Assistant Secretary for Public Affairs (ASPA), as the Agency Chief FOIA Officer (ACFO); that official may be contacted at HHS.ACFO@hhs.gov. Commercial use means a use or pur- pose that furthers a commercial, trade, or profit interest of the requester or the person or entity on whose behalf the request is made. Department or HHS means the U.S. Department of Health and Human Services. Deputy Agency Chief FOIA Officer (DACFO) means a designated official within the Office of the Assistant Sec- retary for Public Affairs, who has been authorized by the Chief FOIA Officer to act upon their behalf to implement compliance with the FOIA, as described above. This official is also the approv- ing review authority for FOIA adminis- trative appeals. Direct costs mean those expenses that an agency incurs in searching for and duplicating (and, in the case of com- mercial use reviewing) records in order to respond to a FOIA request. For example, direct costs in- clude the salary of the employee per- requests, forming the work (i.e., the basic rate of pay for the employee, reviewing) records in order to respond to a FOIA request. For example, direct costs in- clude the salary of the employee per- requests, forming the work (i.e., the basic rate of pay for the employee, plus 16 percent of that rate to cover benefits) and the cost of operating computers and other electronic equipment, such as photo- copiers and scanners. Direct costs do not include overhead expenses such as the costs of space, and of heating or lighting a facility. Duplication means the process of making a copy of a record and sending it to the requester, to the extent nec- essary to respond to the request. Such copies include both paper copies and electronic records. Fees for duplication are further explained within § 5.52. Educational institution means any school that operates a program of scholarly research. A requester in this fee category must show that the re- quest is made in connection with his or her role at the educational institution. Agencies may seek assurance from the requester that the request is in fur- therance of scholarly research. Example 1. A request from a professor of ge- ology at a university for records relating to soil erosion, written on letterhead of the De- er that the request is in fur- therance of scholarly research. Example 1. A request from a professor of ge- ology at a university for records relating to soil erosion, written on letterhead of the De- partment of Geology, would be presumed to be from an educational institution. Example 2. A request from the same pro- fessor of geology seeking drug information from the Food and Drug Administration in furtherance of a murder mystery he is writ- ing would not be presumed to be an institu- tional request, regardless of whether it was written on institutional stationery. Example 3. A student who makes a request in furtherance of their coursework or other school-sponsored activities and provides a copy of a course syllabus or other reasonable documentation to indicate the research pur- pose for the request, would qualify as part of this fee category. Expedited processing means the proc- ess set forth in the FOIA that allows requesters to request faster processing of their FOIA request, if they can dem- onstrate a specific compelling need. Fee category means one of the four categories established by the FOIA to determine whether a requester will be charged fees for search, review, and du- ey can dem- onstrate a specific compelling need. Fee category means one of the four categories established by the FOIA to determine whether a requester will be charged fees for search, review, and du- plication. The categories are: commer- cial use requests; non-commercial sci- entific or educational institutions re- quests; news media requests; and all other requests. Fee categories are fur- ther explained within § 5.53. 19 § 5.3 45 CFR Subtitle A (10–1–24 Edition) Fee waiver means the waiver or re- duction of fees if a requester is able to demonstrate that certain standards set forth in the FOIA and this part are sat- isfied, including that disclosure of the records is in the public interest be- cause it is likely to contribute signifi- cantly to public understanding of the operations or activities of the govern- ment and is not primarily in the com- mercial interest of the requester. First-party request means a request by an individual for records pertaining to that individual, or an authorized rep- resentative acting on such an individ- ual’s behalf. FOIA Public Liaison means an agency official who reports to the agency Chief FOIA Officer and serves as a super- visory official n authorized rep- resentative acting on such an individ- ual’s behalf. FOIA Public Liaison means an agency official who reports to the agency Chief FOIA Officer and serves as a super- visory official to whom a requester can raise concerns about the service the re- quester has received from the FOIA Re- quester Service Center. This individual is responsible for assisting in reducing delays, increasing transparency and understanding of the status of re- quests, and assisting in the resolution of disputes. FOIA request means a written request that reasonably describes the records sought. FOIA library records are records that are required to be made available to the public without a specific request under 5 U.S.C. 552(a)(2). We make FOIA library records available to the public electronically through our Web pages (http://www.hhs.gov/foia/reading/ index.html) and at certain physical lo- cations. A list of the physical locations is available at http://www.hhs.gov/foia/ contacts/index.html. Other records may also be made available at our discre- tion through our Web pages (http:// www.hhs.gov). Freedom of Information Act (FOIA) means the law codified at 5 U.S.C. 552 that provides the publ ther records may also be made available at our discre- tion through our Web pages (http:// www.hhs.gov). Freedom of Information Act (FOIA) means the law codified at 5 U.S.C. 552 that provides the public with the right to request agency records from Federal executive branch agencies. A link to the text of the FOIA is at https:// www.justice.gov/oip/freedom-information- act-5-usc-552. Freedom of Information Act (FOIA) Of- ficer means an HHS official who has been delegated the authority to release or withhold records; to assess, waive, or reduce fees in response to FOIA re- quests; and to determine whether to grant expedited processing. In that ca- pacity, the Freedom of Information Act (FOIA) Officer has the authority to task agency organizational compo- nents to search for records in response to a FOIA request, and to provide records located in their offices. Apart from records subject to proactive dis- closure pursuant to subsection (a)(2) of the FOIA, only FOIA Officers have the authority to release or withhold records or to waive fees in response to a FOIA request. Our FOIA operations are decentralized, and each FOIA Re- quester Service Center has a des- ignated official with thi rity to release or withhold records or to waive fees in response to a FOIA request. Our FOIA operations are decentralized, and each FOIA Re- quester Service Center has a des- ignated official with this authority; the contact information for each FOIA Requester Service Center is available at http://www.hhs.gov/foia/contacts/ index.html. (1) The HHS Freedom of Information Act (FOIA) Officer in the Office of the Secretary means the HHS official who in addition to overseeing the daily op- erations of the FOIA program in that office and having the authority of a Freedom of Information Act (FOIA) Offi- cer, is also responsible for the Depart- ment-wide administration and coordi- nation of the FOIA and its imple- menting regulations and policies as they pertain to the programs and ac- tivities of the Department. This indi- vidual serves as the principal resource with respect to the articulation of pro- cedures designed to implement and en- sure compliance with the FOIA and its implementing regulations and policies as they pertain to the Department. This individual reports through the DACFO to the ACFO to support over- sight and compliance with the OPEN Government Act. (2) [Reserved] Frequ gulations and policies as they pertain to the Department. This individual reports through the DACFO to the ACFO to support over- sight and compliance with the OPEN Government Act. (2) [Reserved] Frequently requested records means records, regardless of form or format, that have been released to any person under the FOIA and that have been re- quested 3 or more times or because of the nature of their subject matter, the agency determines have become or are likely to become the subject of subse- quent requests for substantially the same records. Immediate Office of the Secretary (IOS) means offices within the Office of the Secretary, responsible for operations and work of the Secretary. It includes 20 Dept. of Health and Human Services § 5.3 the Office of the Deputy Secretary, Of- fice of the Chief of Staff, the Sec- retary’s Counselors, the Executive Sec- retariat, the Office of Health Reform, and the Office of Intergovernmental and External Affairs. scientific Non-commercial institution means an institution that is not oper- ated to further a commercial, trade, or profit interest and that is operated solely for the purpose of conducting scientific research the results of which are n means an institution that is not oper- ated to further a commercial, trade, or profit interest and that is operated solely for the purpose of conducting scientific research the results of which are not intended to promote any par- ticular product or industry. A re- quester in this category must show that the request is authorized by and is made under the auspices of a qualifying institution and that the records are sought to further scientific research and are not for a commercial use. Office of the Inspector General (OIG) means the Staff Division within the Of- fice of the Secretary (OS), which is re- sponsible for protecting the integrity of HHS programs and the health and welfare of the beneficiaries of those programs. OIG is responsible for proc- essing FOIA requests for the records it maintains. Office of the Secretary (OS) means the HHS’s chief policy officer and general manager, who administers and oversees the organization, its programs and ac- tivities. The Deputy Secretary and a number of Assistant Secretaries and Staff Divisions support OS. The HHS FOIA Office within ASPA processes FOIA requests for records maintained by OS Staff Divisions other than the OIG. In certai and a number of Assistant Secretaries and Staff Divisions support OS. The HHS FOIA Office within ASPA processes FOIA requests for records maintained by OS Staff Divisions other than the OIG. In certain circumstances and at the HHS FOIA Office’s discretion, the HHS FOIA office may also process FOIA requests involving other HHS OpDivs, as further described in § 5.28(a). Operating Division (OpDiv) means any of the following divisions within HHS which are subject to this regulation: Office of the Secretary (OS) Administration for Children and Families (ACF) Administration for Community Liv- ing (ACL) Agency for Healthcare Research and Quality (AHRQ) Agency for Toxic Substances and Disease Registry (ATSDR) Centers for Disease Control and Prevention (CDC) Centers for Medicare & Medicaid Services (CMS) Food and Drug Administration (FDA) Health Resources and Services Administra- tion (HRSA) Indian Health Service (IHS) National Institutes of Health (NIH) Substance Abuse and Mental Health Services Administration (SAMHSA). Operating Division and Staff Division Freedom of Information Act (FOIA) Offi- cers means the officials who are respon- sible for overseeing the daily oper- ations of their es Administration (SAMHSA). Operating Division and Staff Division Freedom of Information Act (FOIA) Offi- cers means the officials who are respon- sible for overseeing the daily oper- ations of their FOIA programs in their respective Operating Divisions or Staff Divisions, with the full authority as described in the definition of Freedom of Information Act (FOIA) Officer. These individuals serve as the principal re- source and authority for FOIA oper- ations and implementation within their respective Operating Divisions or Staff Divisions. Other requester means any individual or organization whose request does not qualify as a commercial-use request, representative of the news media re- quest (including a request made by a freelance journalist), or an educational or non-commercial scientific institu- tion request. Record means any information that would be an agency record when main- tained by an agency in any format, in- cluding an electronic format; and any information that is maintained for an agency by an entity under Government contract, for the purposes of records management. Redact means delete or mark over. Representative of the news media means any person or entity that ac ined for an agency by an entity under Government contract, for the purposes of records management. Redact means delete or mark over. Representative of the news media means any person or entity that ac- tively gathers information of potential interest to a segment of the public, uses its editorial skills to turn raw ma- terials into a distinct work, and dis- tributes that work to an audience. The term ‘‘news’’ means information that is about current events or that would be of current interest to the public. Ex- amples of news media entities include television or radio stations that broad- cast news to the public at large and publishers of periodicals, including print and online publications that dis- seminate news and make their prod- ucts available through a variety of means to the general public. We do not consider requests for records that sup- port the news-dissemination function of the requester to be a commercial use. We consider ‘‘freelance’’ journal- ists who demonstrate a solid basis for 21 § 5.4 45 CFR Subtitle A (10–1–24 Edition) expecting publication through a news media entity as working for that enti- ty. A publishing contract provides the clearest evidence that a jour basis for 21 § 5.4 45 CFR Subtitle A (10–1–24 Edition) expecting publication through a news media entity as working for that enti- ty. A publishing contract provides the clearest evidence that a journalist ex- pects publication; however, we also consider a requester’s past publication record. Review means examining records re- sponsive to a request to determine whether any portions are exempt from disclosure. Review time includes proc- essing a record for disclosure (i.e., doing all that is necessary to prepare the record for disclosure), including re- dacting the record and marking the ap- propriate FOIA exemptions. Search means the process of identi- fying, locating, and retrieving records to find records responsive to a request, whether in hard copy or in electronic form or format. Staff Division (StaffDiv) means an or- ganization component that provides leadership, direction, and policy and management guidance to the Office of the Secretary and the Department. The following StaffDivs are subject to the regulations in this part: Immediate Office of the Secretary (IOS) Assistant Secretary for Administration (ASA) Assistant Secretary for Financial Resources (ASFR) Assistant Secre ivs are subject to the regulations in this part: Immediate Office of the Secretary (IOS) Assistant Secretary for Administration (ASA) Assistant Secretary for Financial Resources (ASFR) Assistant Secretary for Health (OASH) Assistant Secretary for Legislation (ASL) Assistant Secretary for Planning and Eval- uation (ASPE) Assistant Secretary for Public Affairs (ASPA) Assistant Secretary for Preparedness and Response (ASPR) Departmental Appeals Board (DAB) Office for Civil Rights (OCR) Office of the General Counsel (OGC) Office of Global Affairs (OGA) Office of the Inspector General (OIG) Office of Medicare Hearings and Appeals (OMHA) Office of the National Coordinator for Health Information Technology (ONC) Submitter means any person or entity, including a corporation, State, or for- eign government, but not including an- other Federal Government entity, that provides commercial or financial infor- mation, either directly or indirectly to the Federal Government. Tolling means temporarily stopping the running of a time limit. We may toll a request to seek clarification or to address fee issues, as further de- scribed in § 5.24. § 5.4 Regulatory scope. The requirements in this part app stopping the running of a time limit. We may toll a request to seek clarification or to address fee issues, as further de- scribed in § 5.24. § 5.4 Regulatory scope. The requirements in this part apply to all OpDivs and StaffDivs of HHS. Some OpDivs and StaffDivs may estab- lish or continue to maintain additional rules because of unique program re- quirements, but such rules must be consistent with this part and the FOIA. If additional rules are issued, they must be published in the FEDERAL REG- ISTER and you may get copies online at https://www.federalregister.gov/, http:// www.regulations.gov/ or by contacting one of our FOIA Requester Service Centers. § 5.5 Interrelationship between the FOIA and the Privacy Act of 1974. The FOIA allows any person (whether an individual or entity) to request ac- cess to records. The Privacy Act, at 5 U.S.C. 552a(d), provides an additional right of access, allowing individuals to request records about themselves, if the records are maintained in a system of 5 U.S.C. 552a(a)(5)). (defined records in (a) Requesting records about you. If any part of your request includes records about yourself that are main- tained within a system of records as defi stem of 5 U.S.C. 552a(a)(5)). (defined records in (a) Requesting records about you. If any part of your request includes records about yourself that are main- tained within a system of records as defined by the Privacy Act at 5 U.S.C. 552a(a)(5), you should make your re- quest in accordance with the Privacy Act and the Department’s imple- menting regulations at 45 CFR part 5b. This includes requirements to verify your identity. We will process the re- quest under the Privacy Act and, if it is not fully granted under the Privacy Act, we will process it under the FOIA. You may obtain, under the FOIA, in- formation that is exempt from access under the Privacy Act, if the informa- tion is not excluded or exempt under the FOIA. If you request records about yourself that are not maintained with- in a system of records, we will process your request under the FOIA only. (b) Requesting records about another individual. If you request records about another individual, we will process your request under the FOIA. You may receive greater access by following the procedures described in § 5.22(g). 22 Dept. of Health and Human Services § 5.23 Subpart B—How to Request Records under FOIA § 5.21 Who t under the FOIA. You may receive greater access by following the procedures described in § 5.22(g). 22 Dept. of Health and Human Services § 5.23 Subpart B—How to Request Records under FOIA § 5.21 Who can file a FOIA request? Any individual, partnership, corpora- tion, association, or public or private organization other than a Federal agency, regardless of nationality, may submit a FOIA request to us. This in- cludes state and local governments. § 5.22 What do I include in my FOIA request? In your FOIA request: (a) Provide a written description of the records you seek in sufficient de- tail to enable our staff to locate them with a reasonable amount of effort. The more information you provide, the better possibility we have of finding the records you are seeking. Informa- tion that will help us find the records would include: (1) The agencies, offices, or individ- uals involved; (2) The approximate date(s) when the records were created; (3) The subject, title, or description of the records sought; and (4) Author, recipient, case number, file designation, or other reference number, if available. (b) Include your name, full mailing address, and phone number and if avail- able, your cords sought; and (4) Author, recipient, case number, file designation, or other reference number, if available. (b) Include your name, full mailing address, and phone number and if avail- able, your email address. This informa- tion allows us to reach you faster if we have any questions about your request. It is your responsibility to keep your current mailing address up to date with the office where you have filed the FOIA request. (c) State your willingness to pay all fees, or the maximum amount of fees you are willing to pay, and/or include a request for a fee waiver/reduction. (d) Mark both your letter and enve- lope, or the subject line of your email, with the words ‘‘FOIA Request.’’ (e) If you are unable to submit a written request to us due to cir- cumstances such as disability or lit- eracy, you may make a request orally to a FOIA Officer. FOIA Officers will put in writing an oral request made di- rectly to them. (f) If you are making a first-party re- quest, you must comply with the verification of identity procedures set forth in 45 CFR part 5b. (g) Where your request for records pertains to another individual, you may receive greater access by submit- ting either a nota ith the verification of identity procedures set forth in 45 CFR part 5b. (g) Where your request for records pertains to another individual, you may receive greater access by submit- ting either a notarized authorization signed by that individual or a declara- tion made in compliance with the re- quirements set forth in 28 U.S.C. 1746 by that individual authorizing disclo- sure of the records to the requester, or by submitting proof that the individual is deceased (e.g., a copy of a death cer- tificate or an obituary). At our discre- tion, we may require you to supply ad- ditional information if necessary to verify that a particular individual has consented to disclosure of records about them. (h) If you are requesting the medical records of an individual other than yourself from a government program that pays or provides for health care (e.g. Medicare, Indian Health Service) and you are not that individual’s le- gally authorized representative, you should submit a Health Insurance Port- ability and Accountability Act (HIPAA) compliant release authoriza- tion form signed by the subject of records or the individual’s legally au- thorized representative. The HIPAA Privacy Rule require - ability and Accountability Act (HIPAA) compliant release authoriza- tion form signed by the subject of records or the individual’s legally au- thorized representative. The HIPAA Privacy Rule requires that an author- ization form contain certain core ele- ments and statements which are de- scribed in the Privacy Rule’s require- ments at 45 CFR 164.508. If you are sub- mitting a request for Medicare records to CMS, CMS has a release authoriza- tion form at the following link: ttps:// www.cms.gov/Medicare/CMS-Forms/CMS- Forms/Downloads/CMS10106.pdf. (i) Before filing your request, you may find it helpful to consult the HHS FOIA Requester Service Centers online at http://www.hhs.gov/foia/contacts/ index.html, which provides additional guidance to assist in submitting a FOIA request to a specific OpDiv or StaffDiv or to regional offices or divi- sions within an OpDiv or StaffDiv. You may also wish to check in the agency’s electronic FOIA libraries available on- line at http://www.hhs.gov/foia/reading/ index.html, to see if the information you wish to obtain is already available. § 5.23 Where do I send my FOIA re- quest? We have several FOIA Requester Service Centers (FOIA offices) tha foia/reading/ index.html, to see if the information you wish to obtain is already available. § 5.23 Where do I send my FOIA re- quest? We have several FOIA Requester Service Centers (FOIA offices) that 23 § 5.24 45 CFR Subtitle A (10–1–24 Edition) process FOIA requests. You should send your FOIA request to the appro- priate FOIA Requester Service Center that you believe would have the records you seek. An up-to-date listing is maintained http:// www.hhs.gov/foia/contacts/index.html. You also may submit your request electronically by emailing it to the ap- propriate FOIA Requester Service Cen- ter or by submitting it to the Depart- ment’s web portal located at https://re- quests.publiclink.hhs.gov/palMain.aspx. online at (a) If you are requesting research data made available under the provi- sions of 45 CFR 75.322(e), requests for such data should be addressed to the OpDiv that made the award under which the data were first produced. That OpDiv will process your request in accordance with established proce- dures consistent with the FOIA and 45 CFR 75.322(e). (b) We officially receive your request when it reaches the FOIA Requester Service Center with responsibility for the OpDiv or th established proce- dures consistent with the FOIA and 45 CFR 75.322(e). (b) We officially receive your request when it reaches the FOIA Requester Service Center with responsibility for the OpDiv or StaffDiv where requested records are likely to be located, but no later than 10 working days after the re- quest first arrives at any of our FOIA Requester Service Centers. (c) If you have questions concerning the processing of your FOIA request, you may contact the FOIA Requester Service Center processing your request. If that initial contact does not resolve your concerns, you may wish to con- tact the designated FOIA Public Liai- son for the OpDiv or StaffDiv proc- essing your request. You can find a list of our FOIA Requester Service Centers and Public Liaisons http:// www.hhs.gov/foia/contacts/index.html. at § 5.24 How does HHS process my FOIA request? (a) Acknowledgement. We acknowledge all FOIA requests in writing within 10 working days after receipt by the ap- propriate office. The acknowledgement letter or email informs you of your re- quest tracking number, provides con- tact information, and informs you of any complexity we are aware of in processing that may lengthen the t e acknowledgement letter or email informs you of your re- quest tracking number, provides con- tact information, and informs you of any complexity we are aware of in processing that may lengthen the time required to reach a final decision on the release of the records. In addition, the acknowledgement letter or email or a subsequent communication may also seek additional information to clarify your request. (b) Perfected requests. (1) A request is considered to be perfected (i.e., the 20 working day statutory response time begins to run) when— (i) The request either has been re- ceived by the responsible FOIA office, or, in any event, not later than 10 working days after the request has been received by any HHS FOIA office; (ii) The requested records are reason- ably described; and (iii) The request contains sufficient information to enable the FOIA office to contact you and transmit records to you. (2) We provide at least 20 working days for you to respond to a request to perfect your request, after notification. Requests must reasonably describe the records sought and contain sufficient information to enable the FOIA office to contact you and transmit records to you. If we determ request, after notification. Requests must reasonably describe the records sought and contain sufficient information to enable the FOIA office to contact you and transmit records to you. If we determine that a request does not meet these requirements, we will attempt to contact you if possible. Should you not answer any correspond- ence, or should the correspondence be returned as undeliverable, we reserve the right to administratively close the FOIA request. (c) Stops in processing time (tolling). We may stop the processing of your re- quest one time if we require additional information regarding the specifics of the request. The processing time re- sumes upon our receipt of your re- sponse. We also may stop the proc- essing of your request if we require clarification regarding fee assessments. If additional information or clarifica- tion is required, we will attempt to contact you using the contact informa- tion you have provided. The processing time will resume upon our receipt of your response. We will provide at least 20 working days after notification for you to respond to a request for addi- tional information or clarification re- garding the specifics of your request or fe your response. We will provide at least 20 working days after notification for you to respond to a request for addi- tional information or clarification re- garding the specifics of your request or fee assessment. Should you not answer any correspondence, or should the cor- respondence be returned as undeliver- able, we may administratively close the FOIA request. (d) Search cut-off date. As the end or cut-off date for a records search, we use the date on which we first begin our 24 Dept. of Health and Human Services § 5.25 search for documents responsive to your request, unless you specify an ear- lier cut-off date, or a specific date range for the records search. We will use the date of the first search in those cases when you records ‘‘through the present,’’ ‘‘through today,’’ or similar language. The FOIA allows you to request existing agency records. The FOIA cannot be used to request records which the agency may create in the future in the course of carrying out its mission. request (e) Processing queues. We place FOIA requests in simple or complex proc- essing queues to be processed in the order received, on a first-in, first-out basis, absent approval for expedited processi est (e) Processing queues. We place FOIA requests in simple or complex proc- essing queues to be processed in the order received, on a first-in, first-out basis, absent approval for expedited processing based upon a compelling need, as further explained and defined in § 5.27. We will place your request in the simple or complex processing queue based on the estimated amount of work or time needed to process the request. Among the factors we may consider are the number of records requested, the number of pages involved in processing the request, and the need for consulta- tions or referrals. We will advise re- questers of potential complicating fac- tors in our acknowledgement letter or email, or in subsequent communica- tions regarding your request and, when appropriate, we will offer requesters an opportunity to narrow or modify their request so that it can be placed in the simple processing track. (f) Unusual Circumstances. Whenever we cannot meet the statutory time limit for processing a request because of ‘‘unusual circumstances,’’ as defined in the FOIA, and we extend the time limit on that basis, we will notify you, before expiration of the 20-day period to respond and in writ ng a request because of ‘‘unusual circumstances,’’ as defined in the FOIA, and we extend the time limit on that basis, we will notify you, before expiration of the 20-day period to respond and in writing of the un- usual circumstances involved and of the date by which we estimate proc- essing of the request will be completed. Where the extension exceeds 10 work- ing days, we will provide you, as de- scribed by the FOIA, with an oppor- tunity to modify the request or ar- range an alternative time period for processing the original or modified re- quest. We will make available a des- ignated FOIA contact in the appro- priate FOIA Requester Service Center or the appropriate FOIA Public Liaison for this purpose. In addition, we will inform you of the right to seek dispute resolution services from the Office of Government Services (OGIS). Information satisfying unusual (g) Aggregating requests. For the pur- poses of cir- cumstances, we may aggregate re- quests in cases where it reasonably ap- pears that multiple requests, sub- mitted either by a requester or by a group of requesters acting in concert, constitute a single request, involving clearly related matters, that would otherwise c p- pears that multiple requests, sub- mitted either by a requester or by a group of requesters acting in concert, constitute a single request, involving clearly related matters, that would otherwise cir- cumstances. In the event that requests are aggregated, they will be treated as one request for the purposes of calcu- lating both response time and fees. unusual involve § 5.25 How does HHS handle requests that involve more than one OpDiv, StaffDiv, or Federal agency? (a) Re-routing of misdirected requests. When a FOIA Requester Service Center determines that a request was mis- directed within HHS, the receiving FOIA Requester Service Center must route the request to the FOIA Re- quester Service Center of the proper OpDiv or StaffDiv within HHS. (b) Consultation, referral, and coordi- nation. When reviewing records located by an OpDiv or StaffDiv in response to a request, the OpDiv or StaffDiv will determine whether another agency of the Federal Government is better able to determine whether the record is ex- empt from disclosure under the FOIA. As to any such record, the OpDiv or StaffDiv must proceed in one of the fol- lowing ways: (1) Consultation. When records origi- nated with hether the record is ex- empt from disclosure under the FOIA. As to any such record, the OpDiv or StaffDiv must proceed in one of the fol- lowing ways: (1) Consultation. When records origi- nated with an OpDiv or StaffDiv proc- essing the request, but contain within them information of interest to an- other OpDiv, StaffDiv, agency or other Federal Government office, the OpDiv or StaffDiv processing the request should typically consult with that other entity prior to making a release determination. (2) Referral. (i) When the OpDiv or StaffDiv processing the request be- lieves that a different OpDiv, StaffDiv, or agency is best able to determine whether to disclose the record, the OpDiv or StaffDiv typically should refer the responsibility for responding to the request regarding that record to 25 § 5.26 45 CFR Subtitle A (10–1–24 Edition) that other entity. Ordinarily, the enti- ty that originated the record is pre- sumed to be the best entity to make the disclosure determination. However, if the OpDiv or StaffDiv processing the request and the originating entity jointly agree that the OpDiv or StaffDiv processing the request is in the best position to respond regarding the record, t r, if the OpDiv or StaffDiv processing the request and the originating entity jointly agree that the OpDiv or StaffDiv processing the request is in the best position to respond regarding the record, then the record may be handled as a consultation. (ii) Whenever an OpDiv or StaffDiv refers any part of the responsibility for responding to a request to another OpDiv, StaffDiv, or federal agency, it must document the referral, maintain a copy of the record that it refers, and notify the requester of the referral; in- forming the requester of the name(s) of the entity to which the record was re- ferred, including that entity’s FOIA contact information. (3) Coordination. The standard refer- ral procedure is not appropriate where disclosure of the identity of the OpDiv, StaffDiv, or federal agency to which the referral would be made could harm an interest protected by an applicable exemption, such as the exemptions that protect personal privacy or na- tional security interests. In such in- stances, in order to avoid harm to an interest protected by an applicable ex- emption, the OpDiv or StaffDiv that re- ceived the request should coordinate with the originating entity to seek its views tances, in order to avoid harm to an interest protected by an applicable ex- emption, the OpDiv or StaffDiv that re- ceived the request should coordinate with the originating entity to seek its views on the disclosability of the record. The release determination for the record that is the subject of the co- ordination should then be conveyed to the requester by the OpDiv or StaffDiv that originally received the request. (c) Classified information. On receipt of any request involving classified in- formation, the OpDiv or StaffDiv must determine whether the information is currently and properly classified in ac- cordance with applicable classification rules. Whenever a request involves a record containing information that has been classified or may be appropriate for classification by another agency under any applicable executive order concerning of records, the OpDiv or StaffDiv must refer the responsibility for responding to the request regarding that informa- tion to the agency that classified the information, or which should consider classification the information for classification. the Whenever an OpDiv’s or StaffDiv’s record contains information that has been derivatively cla classified the information, or which should consider classification the information for classification. the Whenever an OpDiv’s or StaffDiv’s record contains information that has been derivatively classified (for exam- ple, when it contains information clas- sified by another agency), the OpDiv or StaffDiv must refer the responsibility for responding to that portion of the request to the agency that classified the underlying information. (d) Timing of responses to consultations and referrals. All consultations and re- ferrals received by the Department will be handled according to the date that the FOIA request initially was received by the first OpDiv, StaffDiv, or federal agency. agreements with (e) Agreements regarding consultations and referrals. OpDivs or StaffDivs may establish other OpDivs, StaffDivs, or federal agencies to eliminate the need for consultations or referrals with respect to particular types of records. § 5.26 How does HHS determine esti- mated completion dates for FOIA requests? (a) When we provide an estimated completion date, in accordance with § 5.24(f) and upon request, for the proc- essing of records that do not require consultation with another agency, w FOIA requests? (a) When we provide an estimated completion date, in accordance with § 5.24(f) and upon request, for the proc- essing of records that do not require consultation with another agency, we estimate the completion date on the basis of our reasonable judgment as to how long it will take to complete the request. Given the uncertainty inher- ent in establishing any estimate, the estimated completion date is subject to change at any time. (b) When we provide an estimated completion date, in accordance with § 5.24(f) and upon request, for records that must be reviewed by another agency, our estimate may also be based on information from the other agency. § 5.27 How do I request expedited processing? (a) To request expedited processing, you must submit a statement, certified to be true and correct, explaining the basis for your need for expedited proc- essing. You must send the request to the appropriate FOIA Officer at the ad- dress listed at http://www.hhs.gov/foia/ contacts/index.html. You may request 26 Dept. of Health and Human Services § 5.29 expedited processing when you first re- quest records or at any time during our processing of your request or appeal. (b) We proc dex.html. You may request 26 Dept. of Health and Human Services § 5.29 expedited processing when you first re- quest records or at any time during our processing of your request or appeal. (b) We process requests on an expe- dited basis whenever we determine that one or more of the following criteria exist: (1) That a failure to obtain requested records on an expedited basis could rea- sonably be expected to pose an immi- nent threat to the life or physical safe- ty of an individual; or (2) There is an urgent need to inform the public about an actual or alleged Federal Government activity (this cri- terion applies only to those requests made by a person primarily engaged in disseminating information to the pub- lic). (c) We will respond to your request for expedited processing within 10 cal- endar days of our receipt of your re- quest to expedite. If we grant your re- quest, the OpDiv or StaffDiv respon- sible for the review of the requested records will process your request as a priority, and it will be processed as soon as practicable. We will inform you if we deny your request for expedited processing and provide you with appeal rights. If you decide to appeal that de- nial, we ity, and it will be processed as soon as practicable. We will inform you if we deny your request for expedited processing and provide you with appeal rights. If you decide to appeal that de- nial, we will expedite our review of your appeal. (d) If we must refer records to an- other agency, we will inform you and suggest that you seek expedited review from that agency. § 5.28 How does HHS respond to my request? (a) The appropriate FOIA Officer will send you a response informing you of our release determination, including whether any responsive records were located, how much responsive material was located, whether the records are being released in full or withheld in full or in part, any fees you must pay for processing of the request, and your right to seek assistance from the ap- propriate FOIA Public Liaison. (b) If we deny any part of your re- quest, our response will explain the reasons for the denial, which FOIA ex- emptions apply the withheld records, your right to appeal that de- termination, and your right to seek dispute resolution services from the ap- propriate FOIA Public Liaison or the to Information Office of Government Services (OGIS). We will advise you of the numbe - termination, and your right to seek dispute resolution services from the ap- propriate FOIA Public Liaison or the to Information Office of Government Services (OGIS). We will advise you of the number of pages withheld or the es- timated volume of withheld records, unless providing such information would harm an interest protected by an applicable FOIA exemption. (c) Records may be withheld in full or in part if any of the nine FOIA exemp- tions apply. If we determine to with- hold part of a record pursuant to an ex- emption, we will provide access to rea- sonably segregable non-exempt infor- mation contained in the record. On the released portion of the record, we indi- cate where the information has been redacted and the exemption(s) we ap- plied, unless including that indication would harm an interest the exemption protects. In Subpart C of this part, we list the exemptions to disclosure that may apply to agency records. (d) We also may deny your request for other reasons, including that a re- quest does not reasonably describe the records sought; the information re- quested is not a record subject to the FOIA; the requested records do not exist, cannot be located, or have been g that a re- quest does not reasonably describe the records sought; the information re- quested is not a record subject to the FOIA; the requested records do not exist, cannot be located, or have been destroyed; or that the requested records are not readily reproducible in the form or format requested. (e) If a request involves a voluminous amount of material or searches in mul- tiple locations, we may provide you with interim responses if feasible and reasonably possible, the records on a rolling basis. releasing (f) Copies of records in the format you request will be provided if the records already exist in that format or if they are reasonably and readily re- producible in the format you request. § 5.29 How may I request assistance with the FOIA process? (a) If you have questions concerning the processing of your FOIA request, you should first contact the FOIA Re- quester Service Center processing your request. Additionally, for assistance at any point in the FOIA process, you may contact the FOIA Public Liaison at the FOIA Requester Service Center processing your request. The FOIA Public Liaison is responsible for assist- ing you to reduce delays, increasing transparency and un ontact the FOIA Public Liaison at the FOIA Requester Service Center processing your request. The FOIA Public Liaison is responsible for assist- ing you to reduce delays, increasing transparency and understanding of the 27 § 5.31 45 CFR Subtitle A (10–1–24 Edition) status of requests, and assisting to re- solve any FOIA disputes. Some FOIA Requester Service Centers allow you to check the status of your request on- line. You can find a list of our FOIA Requester Service Centers and Public Liaisons at http://www.hhs.gov/foia/con- tacts/index.html. (b) The Office of Government Infor- mation Services (OGIS), which is part of the National Archives and Records Administration, serves as the Federal FOIA ombudsman and assists request- ers and agencies to prevent and resolve FOIA disputes through mediation. Me- diation is a voluntary process. If we participate in the dispute resolution services provided by OGIS, we will ac- tively engage as a partner to the proc- ess in an attempt to resolve the dispute and will follow the principles of con- fidentiality in accordance with the Ad- ministrative Dispute Resolution Act, 5 U.S.C. 571–8. You may contact OGIS at the following address: National Ar- dispute and will follow the principles of con- fidentiality in accordance with the Ad- ministrative Dispute Resolution Act, 5 U.S.C. 571–8. You may contact OGIS at the following address: National Ar- chives and Records Administration, Of- fice of Government Information Serv- ices, 8601 Adelphi Road—OGIS, College Park, MD 20740–6001, or by email at ogis@nara.gov, or by telephone at 202– 741–5770 or 1–877–684–6448 (toll free). Subpart C—Exemptions to Disclosure § 5.31 What are the reasons records may be withheld? While we are committed to providing public access to as many of our records as possible, there are instances in which information falls within one or more of the FOIA’s nine exemptions and disclosure would either foreseeably harm an interest protected by a FOIA exemption or disclosure is prohibited by law. We review all records and weigh and assess all legal and policy requirements prior to making a final disclosure determination. A descrip- tion of the nine FOIA exemptions is provided in paragraphs (a) through (i) of this section. (a) Exemption 1. Exemption 1 protects from disclosure information specifi- cally authorized under criteria estab- lished by an Executive order t provided in paragraphs (a) through (i) of this section. (a) Exemption 1. Exemption 1 protects from disclosure information specifi- cally authorized under criteria estab- lished by an Executive order to be kept secret in the interest of national de- fense or foreign policy and are in fact properly classified pursuant to such Executive order. (b) Exemption 2. Exemption 2 author- izes our agency to withhold records that are related solely to the internal personnel rules and practices of an agency. (c) Exemption 3. Exemption 3 author- izes our agency to withhold records which are specifically exempted from disclosure by statute (other than 5 U.S.C. 552(b)) provided that such stat- ute requires that the matters be with- held from the public in such a manner as to leave no discretion on the issue; or establishes particular criteria for withholding or refers to particular types of matters to be withheld; and if enacted after the date of enactment of the OPEN FOIA Act of 2009, October 28, 2009, specifically cites to 5 U.S.C. 552(b)(3). (d) Exemption 4. Exemption 4 author- izes our agency to withhold trade se- crets and commercial or financial in- formation obtained from a person and privil , specifically cites to 5 U.S.C. 552(b)(3). (d) Exemption 4. Exemption 4 author- izes our agency to withhold trade se- crets and commercial or financial in- formation obtained from a person and privileged or confidential. (e) Exemption 5. Exemption 5 author- izes our agency to withhold inter-agen- cy or intra agency memorandums or letters that would not be available by law to a party other than an agency in litigation with the agency, provided that the deliberative process privilege shall not apply to records created 25 years or more before the date on which the records were requested. (f) Exemption 6. Exemption 6 author- izes our agency to protect information in personnel and medical files and similar files when the disclosure of such information would constitute a clearly unwarranted invasion of per- sonal privacy. (g) Exemption 7. Exemption 7 author- izes our agency to withhold records or information compiled for law enforce- ment purposes, but only to the extent that the production of such law en- forcement information records or would cause the following harm(s): (1) Could reasonably be expected to pro- enforcement interfere with ceedings; (2) Would deprive a person of a right of such law en- forcement information records or would cause the following harm(s): (1) Could reasonably be expected to pro- enforcement interfere with ceedings; (2) Would deprive a person of a right to a fair trial or an impartial adjudica- tion; 28 Dept. of Health and Human Services § 5.42 (3) Could reasonably be expected to constitute an unwarranted invasion of personal privacy; (4) Could reasonably be expected to disclose the identity of a confidential source, including a state, local, or for- eign agency or authority, or any pri- vate institution which furnished infor- mation on a confidential basis, and, in the case of a record or information compiled by a criminal law enforce- ment authority in the course of a criminal investigation, or by an agency conducting lawful national security in- telligence investigation, information furnished by a confidential source; (5) Would disclose techniques and procedures for law enforcement inves- tigations or prosecutions, or would dis- close guidelines for law enforcement investigations or prosecutions, if such disclosure could reasonably be ex- pected to risk circumvention of the law; or (6) Could reasonably be expected to endanger the guidelines for law enforcement investigations or prosecutions, if such disclosure could reasonably be ex- pected to risk circumvention of the law; or (6) Could reasonably be expected to endanger the life or physical safety of any individual. (h) Exemption 8. Exemption 8 author- izes our agency to withhold records that are contained in or related to ex- amination, operating, or condition re- ports prepared by, on behalf of, or for the use of an agency responsible for the regulation or supervision of financial institutions. (i) Exemption 9. Exemption 9 author- izes our agency to withhold geological and geophysical information and data, including maps, concerning wells. § 5.32 Records not subject to the re- quirements of the FOIA—law en- forcement exclusions. and national Under the FOIA, there is special pro- tection for narrow categories of law en- security forcement records. The provisions protecting those records are known as ‘‘exclu- sions’’ and are described in 5 U.S.C. 552(c). These exclusions expressly au- thorize Federal law enforcement agen- cies, under these exceptional cir- cumstances, to treat the records as not subject to the requirements of the FOIA. (a) Should an HHS O e exclusions expressly au- thorize Federal law enforcement agen- cies, under these exceptional cir- cumstances, to treat the records as not subject to the requirements of the FOIA. (a) Should an HHS OpDiv or StaffDiv maintain records which are subject to a FOIA exclusion, and consider employ- ing an exclusion or have a question as to the implementation of an exclusion, the OpDiv or StaffDiv will consult with the Office of Information Policy, U.S. Department of Justice. (b) Because records falling within an exclusion are not subject to the re- quirements of the FOIA, should any HHS OpDiv or StaffDiv maintain such excluded records, the OpDiv or StaffDiv will limit its response to those records that are subject to the FOIA. Subpart D—Confidential Commercial Information § 5.41 How does a submitter identify confidential containing records commercial information? A person who submits records to the government may designate part or all of the information in such records that they may consider to be exempt from disclosure under Exemption 4 of the FOIA. The person may make this des- ignation either at the time the records are submitted to the government or within a reasonable time thereafte to be exempt from disclosure under Exemption 4 of the FOIA. The person may make this des- ignation either at the time the records are submitted to the government or within a reasonable time thereafter. The designation must be in writing. Any such designation will expire 10 years after the records were submitted to the government. § 5.42 How does HHS process FOIA re- quests for confidential commercial information? (a) Predisclosure notification. The pro- cedures in this section apply to records on which the submitter has designated information as provided in § 5.41. They also apply to records that were sub- mitted to the government where we have substantial reason to believe that information in the records could rea- sonably be considered exempt under Exemption 4. Certain exceptions to these procedures are stated in para- graph (b) of this section. (1) When we receive a request for such records, and we determine that we may be required to disclose them, we will make reasonable efforts to notify the submitter about these facts. The notice will include a copy of the re- quest, and it will inform the submitter about the procedures and time limits for submission and consideration of ob to notify the submitter about these facts. The notice will include a copy of the re- quest, and it will inform the submitter about the procedures and time limits for submission and consideration of ob- jections to disclosure. If we must no- tify a large number of submitters, we may do this by posting or publishing a 29 § 5.51 45 CFR Subtitle A (10–1–24 Edition) notice in a place where the submitters are reasonably likely to become aware of it. (2) The submitter has 10 working days from the date of the notice to ob- ject to disclosure of any part of the records and to state all bases for its ob- jections. FOIA Offices in HHS and its organizational components may extend this period as appropriate and nec- essary. (3) We review and consider all objec- tions to release that we receive within the time limit. If a submitter fails to respond within the time period speci- fied in the notice, we will consider the submitter to have no objection to dis- closure of the information. If we decide to release the records, we inform the submitter in writing, along with our reasons for the decision to release. We include with the notice a description of the information to be disclosed or cop- ies of release the records, we inform the submitter in writing, along with our reasons for the decision to release. We include with the notice a description of the information to be disclosed or cop- ies of the records as we intend to re- lease them. We also provide the sub- mitter with a specific date that we in- tend to disclose the records, which must be at least 5 working days after the date of the notice. We do not con- sider any information we receive after the date of a disclosure decision. (4) If the requester files a lawsuit under the FOIA for access to records submitted to HHS, we promptly notify the submitter. (5) We will notify the requester in these circumstances: (i) When we notify a submitter that we may be required to disclose infor- mation under the FOIA, we will also notify the requester that notice and opportunity to comment are being pro- vided to the submitter; (ii) When the agency notifies a sub- mitter of a final disclosure decision under the FOIA, and; (iii) When a submitter files a lawsuit to prevent the disclosure of the infor- mation. (b) Exceptions to predisclosure notifica- tion. The notice requirements in para- graph (a) of this section do not apply in the f bmitter files a lawsuit to prevent the disclosure of the infor- mation. (b) Exceptions to predisclosure notifica- tion. The notice requirements in para- graph (a) of this section do not apply in the following situations: (1) We determine that we should withhold the information under a FOIA exemption; (2) The information has been lawfully published or made available to the pub- lic (3) We are required by a statute (other than the FOIA), or by a regula- tion issued in accordance with the re- quirements of Executive Order 12600, to disclose the information; or (4) The designation made by the sub- mitter appears obviously frivolous. However, in such a case, the agency must provide the submitter with writ- ten notice of any final disclosure deter- mination and intent to release, at least 5 working days prior to the specified disclosure date. We will notify the sub- mitter as referenced in § 5.42(a)(3). Subpart E—Fees § 5.51 General information on fees for all FOIA requests. (a) We generally assume that when you request records you are willing to pay the fees we charge for services as- sociated with your request. You may specify a limit on the amount you are willing to spend. We will not assume that when you request records you are willing to pay the fees we charge for services as- sociated with your request. You may specify a limit on the amount you are willing to spend. We will notify you if it appears that the fees will exceed $25.00 or your specified limit and ask whether you nevertheless want us to proceed with the search. (b) If you have failed to pay FOIA fees in the past, we will require you to pay your past due bill and we may also require you to pay the anticipated fee before we begin processing your cur- rent request. If we estimate that your fees may be greater than $250.00, we also may require advance payment or a deposit before we begin processing your request. If you fail to make an advance payment within 20 working days after the date of our fee letter, we will close the request. (c) We may charge interest on unpaid bills beginning on the 31st calendar day following the day the FOIA fee invoice was sent. We may assess interest, ad- ministrative costs, and penalties for overdue FOIA fee costs. (d) If we determine that you (either acting alone or with a group of request- ers) are breaking down a single request into a series of requests in order to av and penalties for overdue FOIA fee costs. (d) If we determine that you (either acting alone or with a group of request- ers) are breaking down a single request into a series of requests in order to avoid or reduce fees, we may aggregate all of these requests when calculating the fees. In aggregating requests, we may consider the subject matter of the 30 Dept. of Health and Human Services § 5.52 requests and whether the requests were filed close in time to one another. (e) If, in the course of negotiating fees, you do not respond to the agency within 20 working days of our last com- munication, your request will be closed. (f) We may stop the processing of your request, if necessary, to clarify fee issues with you, and to confirm your willingness to pay applicable fees. Fee related issues may arise sequen- tially over the course of processing a request, and the FOIA allows agencies to stop the processing time as many times as necessary in order to clarify issues regarding fee assessment and willingness to pay fees. (g) We may charge search fees even if the records are exempt from disclosure, or if we do not find any responsive records during our search. (h) We do not send an invoice and willingness to pay fees. (g) We may charge search fees even if the records are exempt from disclosure, or if we do not find any responsive records during our search. (h) We do not send an invoice to re- questers if assessable processing fees are less than $25.00. § 5.52 What is the FOIA fee schedule for obtaining records? In responding to FOIA requests for records, we charge the following fees, where applicable, unless we have given you a reduction or waiver of fees. The fees we charge for search and review are three-tiered, and the hourly charge is determined by the classification and grade level of the employee performing the search or review. When the search or review is performed by employees at grade GS–1 through GS–8 (or equiva- lent), an hourly rate will be charged based on the salary of a GS–5, step 7, employee; when done by a GS–9 through GS–14 (or equivalent), an hour- ly rate will be charged based on the salary of a GS–12, step 4,employee; and when done by a GS–15 or above (or equivalent), an hourly rate will be charged based on the salary of a GS–15, step 7, employee. In each case, the hourly rate will be computed by taking the current hourly rate listed for the sp ove (or equivalent), an hourly rate will be charged based on the salary of a GS–15, step 7, employee. In each case, the hourly rate will be computed by taking the current hourly rate listed for the specified grade and step in the General Schedule Locality Pay Table for the Locality of Washington-Baltimore- Northern Virginia, DC–MD–VA–WV– PA, adding 16% of that rate to cover benefits, and rounding to the nearest whole dollar. (a) Search fees—(1) Manual searches. Fees will be assessed to search agency files and records in both hardcopy and electronic format. Such fees will be at the rate or rates for the classification of the employee(s) performing the search, as established in this section. (2) Computer searches. We base the fees for computer searches on the ac- tual cost to our agency of operating the computer and the salary of the op- erator. (b) Review fees. (1) We charge review fees for time we spend examining docu- ments that are responsive to a request to determine whether we must apply any FOIA exemptions to withhold in- formation. Review time includes proc- essing any record for disclosure (i.e., doing all that is necessary to prepare the record for disclosure), including re apply any FOIA exemptions to withhold in- formation. Review time includes proc- essing any record for disclosure (i.e., doing all that is necessary to prepare the record for disclosure), including re- dacting the record and marking the ap- propriate FOIA exemptions. We charge review fees even if we ultimately are unable to disclose a record. (2) We do not charge review fees for time we spend resolving general legal or policy issues regarding the applica- tion of exemptions. However, we do charge review fees for time we spend obtaining and considering any formal objection to disclosure made by a con- fidential commercial information sub- mitter. (c) Duplication fees—(1) Photocopying standard-sized current charge for photocopying records is $0.10 per page. pages. The (2) Reproduction of electronic records. We will attempt to provide records in the format you sought, if the records are reasonably and readily reproduc- ible in the requested format. We charge you for our direct costs for staff time and to organize, convert, and format data for release, per requester instruc- tions, and for printouts or electronic media necessary to reproduce elec- tronic records requested under the FOI taff time and to organize, convert, and format data for release, per requester instruc- tions, and for printouts or electronic media necessary to reproduce elec- tronic records requested under the FOIA. (3) Copying other media. We will charge you the direct cost of copying other media. (d) Mailing and special delivery fees. We release records by United States Postal Service or, when appropriate, by electronic means, such as electronic mail or web portal. If a requester seeks special delivery, such as overnight 31 § 5.53 45 CFR Subtitle A (10–1–24 Edition) shipping, we reserve the right to pass on the actual costs of special delivery to the requester. Requesters may pro- vide their mailing account and billing information to the agency, so that they may pay directly for special deliv- ery options. (e) Certification of records. The FOIA does not require agencies to certify records as true copies. We may elect, as a matter of administrative discretion, to certify records upon request; how- ever, such a request must be submitted in writing. Further, we will only cer- tify as true copies records that have not left the agency’s chain of custody. The charge for certification is $25.00 per ever, such a request must be submitted in writing. Further, we will only cer- tify as true copies records that have not left the agency’s chain of custody. The charge for certification is $25.00 per record certified. (f) Other statutes specifically providing for fees. The fee schedule of this section does not apply to fees charged under any statute that specifically requires an OpDiv or StaffDiv to set and collect fees for particular types of records. In instances where records responsive to a request are subject to a statutorily- based fee schedule program, the OpDiv or StaffDiv must inform the requester of the contact information for that program. § 5.53 How does HHS calculate FOIA fees for different categories of re- questers? (a) If you are a commercial use re- quester, we charge you fees for search- ing, reviewing, and duplicating respon- sive records. (b) If you are an educational or non- commercial scientific institution re- quester, or a member of the news media, you are entitled to search time, review time, and up to 100 pages of du- plication (or the cost equivalent for other media) without charge. We charge duplication fees after the first 100 pages (or its cost equival led to search time, review time, and up to 100 pages of du- plication (or the cost equivalent for other media) without charge. We charge duplication fees after the first 100 pages (or its cost equivalent). (c) If you do not fall into either of the categories in paragraphs (a) and (b) of this section (i.e. you are an ‘‘other requester’’), you are entitled to two hours of free search time, up to 100 pages of duplication (or the cost equiv- alent of other media) without charge, and you will not be charged for review time. We may charge for search time beyond the first two hours and for du- plication beyond the first 100 pages (or its cost equivalent). (d)(1) If we fail to comply with the FOIA’s time limits in which to respond to a request, we may not charge search fees, or, in the instances of the re- quester categories referenced in para- graph (b) of this section, may not charge duplication fees, except as de- scribed in (d)(2)-(4). (2) If we have determined that un- usual circumstances as defined by the FOIA apply and we provided timely written notice to the requester in ac- cordance with the FOIA, a failure to comply with the time limit shall be ex- cused for an additional 10 days as defined by the FOIA apply and we provided timely written notice to the requester in ac- cordance with the FOIA, a failure to comply with the time limit shall be ex- cused for an additional 10 days. (3) If we have determined that un- usual circumstances, as defined by the FOIA, apply and more than 5,000 pages are necessary to respond to the re- quest, we may charge search fees, or, in the instances of requests from request- ers described in paragraph (b) of this section, may charge duplication fees if the following steps are taken: we must have provided timely written notice to the requester in accordance with the FOIA and must have discussed with the requester via written mail, email, or telephone (or made not less than three good-faith attempts to do so) how the requester could effectively limit the scope of the request in accordance with 5. U.S.C. 552(a)(6)(B)(ii). If this excep- tion is satisfied, we may charge all ap- plicable fees incurred in the processing of the request. (4) If a court has determined that ex- ceptional circumstances exist, as de- fined by the FOIA, a failure to comply with the time limits shall be excused for the length of time provided by the court orde If a court has determined that ex- ceptional circumstances exist, as de- fined by the FOIA, a failure to comply with the time limits shall be excused for the length of time provided by the court order. § 5.54 How may I request a fee waiver? (a) Requesters may seek a waiver of fees by submitting a written applica- tion demonstrating how disclosure of the requested information is in the public interest because it is likely to contribute significantly to public un- derstanding of the operations or activi- ties of the government and is not pri- marily in the commercial interest of the requester. (b) We must furnish records respon- sive to a request without charge or at a reduced rate when we determine, based on all available information, 32 Dept. of Health and Human Services § 5.62 that the following three factors are satisfied: (1) Disclosure of the requested infor- mation would shed light on the oper- ations or activities of the government. The subject of the request must con- cern identifiable operations or activi- ties of the Federal Government with a connection that is direct and clear, not remote or attenuated. (2) Disclosure of the requested infor- mation would be likely to con tifiable operations or activi- ties of the Federal Government with a connection that is direct and clear, not remote or attenuated. (2) Disclosure of the requested infor- mation would be likely to contribute significantly to public understanding of those operations or activities. This factor is satisfied when the following criteria are met: the (i) Disclosure of requested records must be meaningfully inform- ative about government operations or activities. The disclosure of informa- tion that already is in the public do- main, in either the same or a substan- tially identical form, would not be meaningfully informative if nothing new would be added to the public’s un- derstanding. (ii) The disclosure must contribute to the understanding of a reasonably broad audience of persons interested in the subject, as opposed to the indi- vidual understanding of the requester. A requester’s expertise in the subject area as well as the requester’s ability and intention to effectively convey in- formation to the public must be consid- ered. We will presume that a represent- ative of the news media will satisfy this consideration. (3) The disclosure must not be pri- marily in the commercial inte rmation to the public must be consid- ered. We will presume that a represent- ative of the news media will satisfy this consideration. (3) The disclosure must not be pri- marily in the commercial interest of the requester. To determine whether disclosure of the requested information is primarily in the commercial interest of the requester, we will consider the following criteria: (i) We will identify whether the re- quester has any commercial interest that would be furthered by the re- quested disclosure. A commercial in- terest includes any commercial, trade, or profit interest. Requesters will be given an opportunity to provide ex- planatory information regarding this consideration. (ii) If there is an identified commer- cial interest, we will determine wheth- interest is the primary er that furthered by the request. A waiver or reduction of fees is justified when the requirements of paragraphs (b)(1) and (2) of this section are satisfied and any commercial interest is not the primary interest furthered by the request. We ordinarily will presume that when a news media requester has satisfied fac- tors (b)(1) and (2) of this section, the request is not primarily in the com- mercia y interest furthered by the request. We ordinarily will presume that when a news media requester has satisfied fac- tors (b)(1) and (2) of this section, the request is not primarily in the com- mercial interest of the requester. Dis- closure to data brokers or others who merely compile and market govern- ment information for direct economic return will not be presumed to pri- marily serve the public interest. (c) You should ask for waiver or re- duction of fees when you first submit your request to HHS, and should ad- dress the criteria referenced in this section. Subpart F—Appeals § 5.61 When may I appeal HHS’s FOIA determination? In order to fully exhaust all of your administrative remedies, you must file an appeal of an adverse agency deter- mination in writing, and to be consid- ered timely it must be postmarked, or in the case of electronic submissions, transmitted within 90 calendar days from the date of such determination. Any electronic transmission made after normal business hours will be considered to have been transmitted on the next calendar day. If a postmark is not legible, the timeliness of a submis- sion will be based on the date that we receive the appeal. Adverse ours will be considered to have been transmitted on the next calendar day. If a postmark is not legible, the timeliness of a submis- sion will be based on the date that we receive the appeal. Adverse determina- tions include: (a) Refusal to release a record, either in whole or in part; (b) Determination that a record does not exist or cannot be found; (c) Determination that a request does not reasonably describe the records sought; (d) Determination that the record you sought was not subject to the FOIA; (e) Denial of a request for expedited processing; (f) Denial of a fee waiver request; or (g) Fee category determination. § 5.62 How do I file an appeal? (a) You have the right to appeal an adverse agency determination of your FOIA request. 33 § 5.63 45 CFR Subtitle A (10–1–24 Edition) (b) You may submit your appeal via mail or electronically. (1) Please send your appeal to the re- view official at the address provided in your denial letter. If you are unsure who is the appropriate review official, please contact the FOIA Requester Service Center that processed your re- quest to obtain that information. (2) The addresses to mail FOIA ap- peals for CMS and OS are, respectively: Cente ew official, please contact the FOIA Requester Service Center that processed your re- quest to obtain that information. (2) The addresses to mail FOIA ap- peals for CMS and OS are, respectively: Centers for Medicare & Medicaid Serv- ices, Attn: Principal Deputy Adminis- trator, Room C5–16- 03, 7500 Security Boulevard, Baltimore, MD 21244; and U.S. Department of Health and Human Services, Deputy Agency Chief FOIA Officer, Office of the Assistant Sec- retary for Public Affairs, Room 729H, 200 Independence Avenue SW., Wash- ington, DC 20201. Additionally, infor- mation, including how to submit a FOIA appeal electronically, can be found at the following online locations for CMS and OS: https://www.cms.gov/ Regulations-and-Guidance/Legislation/ FOIA/filehow.html quests.publiclink.hhs.gov/palMain.aspx. https://re- and (3) When submitting an appeal, you should mark both your letter and enve- lope with the words ‘‘FOIA Appeal’’ or include the words ‘‘FOIA Appeal’’ in the subject line of your email. You should also include your FOIA request tracking number, a copy of your initial request, and a copy of our final deter- mination letter. (c) Your appeal should clearly iden- tify the agency de mail. You should also include your FOIA request tracking number, a copy of your initial request, and a copy of our final deter- mination letter. (c) Your appeal should clearly iden- tify the agency determination that is being appealed. It would be helpful if you provide specific reasons explaining why you believe the agency’s adverse determination should be reconsidered. § 5.63 How does HHS process appeals? (a) We respond to your appeal within 20 working days after the appeal offi- cial designated in your appeal letter receives it. If, however, your appeal is based on a denial of a request for expe- dited processing, we will act on your appeal of that decision expeditiously. Before making a decision on an appeal of an adverse determination, the des- ignated review official will consult with the Office of the General Counsel. Also, the concurrence of the Office of the Assistant Secretary for Public Af- fairs is required in all appeal decisions, including those on fees. When the re- view official responds to an appeal, that constitutes the Department’s final action on the request. (b) If we reverse or modify the initial decision, we will inform you in writing and, if applicable, repr official responds to an appeal, that constitutes the Department’s final action on the request. (b) If we reverse or modify the initial decision, we will inform you in writing and, if applicable, reprocess your re- quest. If we do not change our initial decision, we will respond in writing to you, explain the reasons for the deci- sion, set out any FOIA exemptions that apply, and inform you of the provisions for judicial review. If a requester files a FOIA lawsuit in reference to an ap- peal, we will cease processing the ap- peal. § 5.64 What avenues are available to me if I disagree with HHS’s appeal decision? (a) In our response letter, we notify you of your right to seek judicial re- view of an adverse determination as set in the FOIA at 5 U.S.C. forth 552(a)(4)(B). Before seeking review by a court of an adverse determination, you generally must first submit a timely administrative appeal. (b) We also inform you that the Of- fice of Government Information Serv- ices (OGIS) offers mediation services to resolve disputes between FOIA request- ers and Federal agencies as a non-ex- clusive alternative to litigation. As referenced in § 5.29(b) you may contact OGIS via mail, email, or diation services to resolve disputes between FOIA request- ers and Federal agencies as a non-ex- clusive alternative to litigation. As referenced in § 5.29(b) you may contact OGIS via mail, email, or telephone for assistance. Subpart G—Records Retention § 5.71 How does HHS retain FOIA records? We will preserve records created in administering the Department’s Free- dom of Information program until dis- position is authorized under an applica- ble General Records Schedule or other records schedule duly approved by the Archivist of the United States. PART 5a [RESERVED] PART 5b—PRIVACY ACT REGULATIONS Sec. 5b.1 Definitions. 5b.2 Purpose and scope. 5b.3 Policy. 34 Dept. of Health and Human Services § 5b.1 5b.4 Maintenance of records. 5b.5 Notification of or access to records. 5b.6 Special procedures for notification of or access to medical records. 5b.7 Procedures for correction or amend- ment of records. 5b.8 Appeals of refusals to correct or amend records. 5b.9 Disclosure of records. 5b.10 Parents and guardians. 5b.11 Exempt systems. 5b.12 Contractors. 5b.13 Fees. APPENDIX A TO PART 5b—EMPLOYEE STAND- ARDS OF CONDUCT APPENDIX B TO PART 5b—ROUTINE USES AP- PLICABLE TO MORE THAN ONE SY 10 Parents and guardians. 5b.11 Exempt systems. 5b.12 Contractors. 5b.13 Fees. APPENDIX A TO PART 5b—EMPLOYEE STAND- ARDS OF CONDUCT APPENDIX B TO PART 5b—ROUTINE USES AP- PLICABLE TO MORE THAN ONE SYSTEM OF RECORDS MAINTAINED BY HHS APPENDIX C TO PART 5b—DELEGATIONS OF AU- THORITY [RESERVED] AUTHORITY: 5 U.S.C. 301, 5 U.S.C. 552a. SOURCE: 40 FR 47409, Oct. 8, 1975, unless otherwise noted. § 5b.1 Definitions. As used in this part: (a) Access means availability of a record to a subject individual. (b) Agency means the Department of Health and Human Services. (c) Department means the Department of Health and Human Services. (d) Disclosure means the availability or release of a record to anyone other than the subject individual. (e) Individual means a living person who is a citizen of the United States or an alien lawfully admitted for perma- nent residence. It does not include per- sons such as sole proprietorships, part- nerships, or corporations. A business firm which is identified by the name of one or more persons is not an indi- vidual within the meaning of this part. (f) Maintain means to maintain, col- lect, use, or disseminate when used in connection with the term ‘‘record’’; the name of one or more persons is not an indi- vidual within the meaning of this part. (f) Maintain means to maintain, col- lect, use, or disseminate when used in connection with the term ‘‘record’’; and, to have control over or responsi- bility for a system of records when used in connection with the term ‘‘sys- tem of records.’’ (g) Notification means communication to an individual whether he is a subject individual. (h) Record means any item, collec- tion, or grouping of information about an individual that is maintained by the Department, including but not limited to the individual’s education, financial transactions, medical history, and criminal or employment history and that contains his name, or an identi- fying number, symbol, or other identi- fying particular assigned to the indi- vidual, such as a finger or voice print or a photograph. When used in this part, record means only a record which is in a system of records. (i) Responsible Department official means that officer who is listed in a notice of a system of records as the system manager for a given system of records or another individual listed in the notice of a system of records to whom requests may be made, or t ho is listed in a notice of a system of records as the system manager for a given system of records or another individual listed in the notice of a system of records to whom requests may be made, or the designee of either such officer or indi- vidual. (j) Routine use means the disclosure of a record outside the Department, without the consent of the subject indi- vidual, for a purpose which is compat- ible with the purpose for which the record was collected. It includes disclo- sures required to be made by statute other than the Freedom of Information Act, 5 U.S.C. 552. It does not include disclosures which are permitted to be made without the consent of the sub- ject individual which are not compat- ible with the purpose for which it was collected such as disclosures to the Bu- reau of the Census, the General Ac- counting Office, or to Congress. (k) Secretary means the Secretary of Health and Human Services, or his des- ignee. (l) Statistical record means a record maintained for statistical research or reporting purposes only and not main- tained to make determinations about a particular subject individual. (m) Subject individual means that in- dividual to whom a record pertains. stical research or reporting purposes only and not main- tained to make determinations about a particular subject individual. (m) Subject individual means that in- dividual to whom a record pertains. (n) System of records means any group of records under the control of the De- partment from which a record is re- trieved by personal identifier such as the name of the individual, number, symbol or other unique retriever as- signed to the individual. Single records or groups of records which are not re- trieved by a personal identifier are not part of a system of records. Papers maintained by individual employees of the Department which are prepared, maintained, or discarded at the discre- tion of the employee and which are not subject to the Federal Records Act, 44 U.S.C. 2901, are not part of a system of records; Provided, That such personal 35 § 5b.2 45 CFR Subtitle A (10–1–24 Edition) papers are not used by the employee or the Department to determine any rights, benefits, or privileges of indi- viduals. § 5b.2 Purpose and scope. (a) This part implements section 3 of the Privacy Act of 1974, 5 U.S.C. 552a (hereinafter referred to as the Act), by establishing agency policies and pro s of indi- viduals. § 5b.2 Purpose and scope. (a) This part implements section 3 of the Privacy Act of 1974, 5 U.S.C. 552a (hereinafter referred to as the Act), by establishing agency policies and proce- dures for the maintenance of records. This part also establishes agency poli- cies and procedures under which a sub- ject individual may be given notifica- tion of or access to a record pertaining to him and policies and procedures under which a subject individual may have his record corrected or amended if he believes that his record is not accu- rate, timely, complete, or relevant or necessary to accomplish a Department function. (b) All components of the Depart- ment are governed by the provisions of this part. Also governed by the provi- sions of this part are: (1) Certain non-Federal entities which operate as agents of the Depart- ment for purposes of carrying out Fed- eral functions, such as intermediaries and carriers performing functions under contracts and agreements en- tered into pursuant to sections 1816 and 1842 of the Social Security Act, 42 U.S.C. 1395h and 1395u. (2) Advisory committees and councils within the meaning of the Federal Ad- visory Committee Act which pr into pursuant to sections 1816 and 1842 of the Social Security Act, 42 U.S.C. 1395h and 1395u. (2) Advisory committees and councils within the meaning of the Federal Ad- visory Committee Act which provide advice to (i) any official or component of the Department or (ii) the President and for which the Department has been delegated responsibility for providing services. (c) Employees of the Department governed by this part include all reg- ular and special government employees of the Department; members of the Public Health Service Commissioned Corps; experts and consultants whose temporary (not in excess of 1 year) or intermittent services have been pro- cured by the Department by contract pursuant to 3109 of Title 5, United States Code; volunteers where accept- ance of their services are authorized by law; those individuals performing gra- tuitous services as permitted under conditions prescribed by the Civil Serv- ice Commission; and, participants in work-study or training programs. (d) Where other statutes mandate procedures which are inconsistent with the procedures set forth in this part, components of the Department may issue supplementary regulations con- taining procedures (d) Where other statutes mandate procedures which are inconsistent with the procedures set forth in this part, components of the Department may issue supplementary regulations con- taining procedures necessary to comply with such statutes. In addition, compo- nents of the Department may supple- ment by regulation the policies and procedures set forth in this part to meet particular needs of the programs administered by such components. (e) This part does not: (1) Make available to a subject indi- vidual records which are not retrieved by that individual’s name or other per- sonal identifier. (2) Make available to the general public records which are retrieved by a subject individual’s name or other per- sonal identifier or make available to the general public records which would otherwise not be available to the gen- eral public under the Freedom of Infor- mation Act, 5 U.S.C. 552, and part 5 of this title. (3) Govern the maintenance or disclo- sure of, notification of or access to, records in the possession of the Depart- ment which are subject to regulations of another agency, such as personnel records subject to the regulations of the Civil Service Commission. (4) Apply to gran ecords in the possession of the Depart- ment which are subject to regulations of another agency, such as personnel records subject to the regulations of the Civil Service Commission. (4) Apply to grantees, including State and local governments or subdivisions thereof, administering federally funded programs. (5) Make available records compiled by the Department in reasonable an- ticipation of court litigation or formal administrative proceedings. The avail- ability of such records to the general public or to any subject individual or party to such litigation or proceedings shall be governed by applicable con- stitutional principles, rules of dis- covery, and applicable regulations of the Department and any of its compo- nents. § 5b.3 Policy. It is the policy of the Department to protect the privacy of individuals to the fullest extent possible while none- theless permitting the exchange of records required to fulfill the adminis- trative and program responsibilities of 36 Dept. of Health and Human Services § 5b.5 the Department, and responsibilities of the Department for disclosing records which the general public is entitled to have under the Freedom of Information Act, 5 U.S.C. 5 th and Human Services § 5b.5 the Department, and responsibilities of the Department for disclosing records which the general public is entitled to have under the Freedom of Information Act, 5 U.S.C. 552, and part 5 of this title. § 5b.4 Maintenance of records. (a) No record will be maintained by the Department unless: (1) It is relevant and necessary to ac- complish a Department function re- quired to be accomplished by statute or Executive Order; (2) It is acquired to the greatest ex- tent practicable from the subject indi- vidual when maintenance of the record may result in a determination about the subject individual’s rights, benefits or privileges under Federal programs; (3) The individual providing the record is informed of the authority for providing the record (including wheth- er the providing of the record is man- datory or voluntary, the principal pur- pose for maintaining the record, the routine uses for the record, what effect his refusal to provide the record may have on him), and if the record is not required by statute or Executive Order to be provided by the individual, he agrees to provide the record. (b) No record will be maintained by the Department which descri him), and if the record is not required by statute or Executive Order to be provided by the individual, he agrees to provide the record. (b) No record will be maintained by the Department which describes how an individual exercises rights guaran- teed by the First Amendment unless expressly authorized (1) by statute, or (2) by the subject individual, or (3) un- less pertinent to and within the scope of an authorized law enforcement ac- tivity. § 5b.5 Notification of or access to records. (a) Times, places, and manner of re- questing notification of or access to a record. (1) Subject to the provisions governing medical records in § 5b.6 of this part, any individual may request notification of a record. He may at the same time request access to any record pertaining to him. An individual may be accompanied by another individual of his choice when he requests access to a record in person; Provided, That he affirmatively authorizes the presence of such other individual during any dis- cussion of a record to which access is requested. (2) An individual making a request for notification of or access to a record shall address his request to the respon- sible Department official and shall ion of a record to which access is requested. (2) An individual making a request for notification of or access to a record shall address his request to the respon- sible Department official and shall verify his identity when required in ac- cordance with paragraph (b)(2) of this section. At the time the request is made, the individual shall specify which systems of records he wishes to have searched and the records to which he wishes to have access. He may also request that copies be made of all or any such records. An individual shall also provide the responsible Depart- ment official with sufficient particu- lars to enable such official to distin- guish between records on subject indi- viduals with the same name. The nec- essary particulars are set forth in the notices of systems of records. (3) An individual who makes a re- quest in person may leave with any re- sponsible Department official a request for notification of or access to a record under the control of another respon- sible Department official; Provided, That the request is addressed in writ- ing to the appropriate responsible De- partment official. (b) Verification of identity—(1) When required. Unless an individual, le Department official; Provided, That the request is addressed in writ- ing to the appropriate responsible De- partment official. (b) Verification of identity—(1) When required. Unless an individual, who is making a request for notification of or access to a record in person, is person- ally known to the responsible Depart- ment official, he shall be required to verify his identity in accordance with paragraph (b)(2) of this section if: (i) He makes a request for notifica- tion of a record and the responsible De- partment official determines that the mere disclosure of the existence of the record would be a clearly unwarranted invasion of privacy if disclosed to someone other than the subject indi- vidual; or, (ii) He makes a request for access to a record which is not required to be disclosed to the general public under the Freedom of Information Act, 5 U.S.C. 552, and part 5 of this title. (2) Manner of verifying identity. (i) An individual who makes a request in per- son shall provide to the responsible De- partment official at least one piece of tangible identification such as a driv- er’s license, passport, alien or voter registration card, or union card to verify his identit ide to the responsible De- partment official at least one piece of tangible identification such as a driv- er’s license, passport, alien or voter registration card, or union card to verify his identity. If an individual does not have identification papers to 37 § 5b.6 45 CFR Subtitle A (10–1–24 Edition) verify his identity, he shall certify in writing that he is the individual who he claims to be and that he under- stands that the knowing and willful re- quest for or acquisition of a record per- taining to an individual under false pretenses is a criminal offense under the Act subject to a $5,000 fine. (ii) Except as provided in paragraph (b)(2)(v) of this section, an individual who does not make a request in person shall submit a notarized request to the responsible Department official to verify his identity or shall certify in his request that he is the individual who he claims to be and that he under- stands that the knowing and willful re- quest for or acquisition of a record per- taining to an individual under false pretenses is a criminal offense under the Act subject to a $5,000 fine. (iii) An individual who makes a re- quest on behalf of a minor or legal in- competent as au taining to an individual under false pretenses is a criminal offense under the Act subject to a $5,000 fine. (iii) An individual who makes a re- quest on behalf of a minor or legal in- competent as authorized under § 5b.10 of this part shall verify his relationship to the minor or legal incompetent, in addition to verifying his own identity, by providing a copy of the minor’s birth certificate, a court order, or other competent evidence of guardian- ship to the responsible Department of- ficial; except that, an individual is not required to verify his relationship to the minor or legal incompetent when he is not required to verify his own identity or when evidence of his rela- tionship to the minor or legal incom- petent has been previously given to the responsible Department official. (iv) An individual shall further verify his identity if he is requesting notifica- tion of or access to sensitive records such as medical records. Any further verification shall parallel the record to which notification or access is being sought. Such further verification may include such particulars as the individ- ual’s years of attendance at a par- ticular educational institution, rank attained in ich notification or access is being sought. Such further verification may include such particulars as the individ- ual’s years of attendance at a par- ticular educational institution, rank attained in the uniformed services, date or place of birth, names of par- ents, an occupation or the specific times the individual received medical treatment. (v) An individual who makes a re- quest by telephone shall verify his identity by providing to the respon- sible Department official identifying particulars which parallel the record to which notification or access is being sought. If the responsible Department official determines that the particulars provided by telephone are insufficient, the requester will be required to sub- mit the request in writing or in person. Telephone requests will not be accept- ed where an individual is requesting notification of or access to sensitive records such as medical records. (c) Granting notification of or access to a record. (1) Subject to the provisions governing medical records in § 5b.6 of this part and the provisions governing exempt systems in § 5b.11 of this part, a responsible Department official, who receives a request for notification of or governing medical records in § 5b.6 of this part and the provisions governing exempt systems in § 5b.11 of this part, a responsible Department official, who receives a request for notification of or access to a record and, if required, verification of an individual’s identity, will review the request and grant noti- fication or access to a record, if the in- dividual requesting access to the record is the subject individual. (2) If the responsible Department of- ficial determines that there will be a delay in responding to a request be- cause of the number of requests being processed, a breakdown of equipment, shortage of personnel, storage of records in other locations, etc., he will so inform the individual and indicate when notification or access will be granted. (3) Prior to granting notification of or access to a record, the responsible Department official may at his discre- tion require an individual making a re- quest in person to reduce his request to writing if the individual has not al- ready done so at the time the request is made. § 5b.6 Special procedures for notifica- tion of or access to medical records. (a) General. An individual in general has a right to notificat has not al- ready done so at the time the request is made. § 5b.6 Special procedures for notifica- tion of or access to medical records. (a) General. An individual in general has a right to notification of or access to his medical records, including psy- chological records, as well as to other records pertaining to him maintained by the Department. This section sets forth special procedures as permitted by the Act for notification of or access to medical records, including a special procedure for notification of or access to medical records of minors. The spe- cial procedures set forth in paragraph (b) of this section may not be suitable for use by every component of the De- partment. Therefore, components may 38 Dept. of Health and Human Services § 5b.7 follow the paragraph (b) procedure for notification of or access to medical records, or may issue regulations es- tablishing special procedures for such purposes. The special procedure set forth in paragraph (c) of this section relating to medical records of minors is mandatory. (b) Medical records procedures—(1) No- tification of or access to medical records. (i) Any individual may request notifi- cation of or access to a medical ng to medical records of minors is mandatory. (b) Medical records procedures—(1) No- tification of or access to medical records. (i) Any individual may request notifi- cation of or access to a medical record pertaining to him. Unless the indi- vidual is a parent or guardian request- ing notification of or access to a mi- nor’s medical record, an individual shall make a request for a medical record in accordance with this section and the procedures in § 5b.5 of this part. (ii) An individual who requests notifi- cation of or access to a medical record shall, at the time the request is made, designate a representative in writing. The representative may be a physician, other health professional, or other re- sponsible individual, who would be willing to review the record and inform the subject individual of its contents at the representative’s discretion. (2) Utilization of the designated rep- resentative. A subject individual will be granted direct access to a medical record if the responsible official deter- mines that direct access is not likely to have an adverse effect on the subject individual. If the responsible Depart- ment official believes that he is not qualified to determin sible official deter- mines that direct access is not likely to have an adverse effect on the subject individual. If the responsible Depart- ment official believes that he is not qualified to determine, or if he does de- termine, that direct access to the sub- ject individual is likely to have an ad- verse effect on the subject individual, the record will be sent to the des- ignated representative. The subject in- dividual will be informed in writing that the record has been sent. (c) Medical records of minors—(1) Re- quests by minors; notification of or access to medical records to minors. A minor may request notification of or access to a medical record pertaining to him in accordance with paragraph (b) of this section. (2) Requests on a minor’s behalf; notifi- cation of or access to medical records to an individual on a minor’s behalf. (i) In order to protect the privacy of a minor, a parent or guardian, authorized to act on a minor’s behalf as provided in § 5b.10 of this part, who makes a re- quest for notification of or access to a minor’s medical record will not be given direct notification of or access to such record. (ii) A parent or guardian shall make all requests for not makes a re- quest for notification of or access to a minor’s medical record will not be given direct notification of or access to such record. (ii) A parent or guardian shall make all requests for notification of or ac- cess to a minor’s medical record in ac- cordance with this paragraph and the procedures in § 5b.5 of this part. A par- ent or guardian shall at the time he makes a request designate a family physician or other health professional (other than a family member) to whom the record, if any, will be sent. (iii) Where a medical record on the minor exists, it will be sent to the phy- sician or health professional des- ignated by the parent or guardian in all cases. If disclosure of the record would constitute an invasion of the mi- nor’s privacy, that fact will be brought to the attention of the physician or health professional to whom the record is sent. The physician or health profes- sional will be asked to consider the ef- fect that disclosure of the record to the parent or guardian would have on the minor in determining whether the mi- nor’s medical record should be made available to the parent or guardian. Response to the parent or guardian making the request will be guardian would have on the minor in determining whether the mi- nor’s medical record should be made available to the parent or guardian. Response to the parent or guardian making the request will be made in substantially the following form: We have completed processing your request for notification of or access to ——————— ________________________________________’s (Name of minor) medical records. Please be informed that if any medical record were found pertaining to that individual, they have not been sent to your designated physician or health profes- sional. In each case where a minor’s medical record is sent to a physician or health professional, reasonable efforts will be made to so inform the minor. § 5b.7 Procedures for correction or amendment of records. (a) Any subject individual may re- quest that his record be corrected or amended if he believes that the record is not accurate, timely, complete, or relevant or necessary to accomplish a Department function. A subject indi- vidual making a request to amend or correct his record shall address his re- quest to the responsible Department 39 § 5b.8 45 CFR Subtitle A (10–1–24 Edition) official in writing; except that, the re- q dual making a request to amend or correct his record shall address his re- quest to the responsible Department 39 § 5b.8 45 CFR Subtitle A (10–1–24 Edition) official in writing; except that, the re- quest need not be in writing if the sub- ject individual makes his request in person and the responsible Department official corrects or amends the record at that time. The subject individual shall specify in each request: (1) The system of records from which the record is retrieved; (2) The particular record which he is seeking to correct or amend; (3) Whether he is seeking an addition to or a deletion or substitution of the record; and, (4) His reasons for requesting correc- tion or amendment of the record. (b) A request for correction or amendment of a record will be ac- knowledged within 10 working days of its receipt unless the request can be processed and the subject individual in- formed of the responsible Department official’s decision on the request within that 10 day period. (c) If the responsible Department of- ficial agrees that the record is not ac- curate, timely, or complete based on a preponderance of the evidence, the record will be corrected or amended. The record will f the responsible Department of- ficial agrees that the record is not ac- curate, timely, or complete based on a preponderance of the evidence, the record will be corrected or amended. The record will be deleted without re- gard to its accuracy, if the record is not relevant or necessary to accom- plish the Department function for which the record was provided or is maintained. In either case, the subject individual will be informed in writing of the correction, amendment, or dele- tion and, if accounting was made of prior disclosures of the record, all pre- vious recipients of the record will be informed of the corrective action taken. (d) If the responsible Department of- ficial does not agree that the record should be corrected or amended, the subject individual will be informed in writing of the refusal to correct or amend the record. He will also be in- formed that he may appeal the refusal to correct or amend his record to the appropriate appeal authority listed in § 5b.8 of this part. The appropriate ap- peal authority will be identified to the subject individual by name, title, and business address. (e) Requests to correct or amend a record governed by the regulation of ano part. The appropriate ap- peal authority will be identified to the subject individual by name, title, and business address. (e) Requests to correct or amend a record governed by the regulation of another government agency, e.g., Civil Service Commission, Federal Bureau of Investigation, will be forwarded to such government agency for processing and the subject individual will be in- formed in writing of the referral. § 5b.8 Appeals of refusals to correct or amend records. (a) Processing the appeal. (1) A subject individual who disagrees with a refusal to correct or amend his record may ap- peal the refusal in writing. All appeals shall be made to the following appeal authorities, or their designees, or suc- cessors in function: (i) Assistant Secretary for Adminis- tration and Management for records of the Office of the Secretary, or where the initial refusal to correct or amend was made by another appeal authority. The appeal authority for an initial re- fusal by the Assistant Secretary for Administration and Management is the Under Secretary. (ii) Assistant Secretary for Health for records of the Public Health Serv- ice including Office of Assistant Sec- retary for Health; Health ry for Administration and Management is the Under Secretary. (ii) Assistant Secretary for Health for records of the Public Health Serv- ice including Office of Assistant Sec- retary for Health; Health Resources Administration; Health Services Ad- ministration; Alcohol, Drug Abuse, and Mental Health Administration; Center for Disease Control; National Insti- tutes of Health; and Food and Drug Ad- ministration. (iii) Assistant Secretary for Edu- cation for records of the Office of the Assistant Secretary for Education, Na- tional Center for Education Statistics, National Institute of Education, and Office of Education. (iv) Assistant Secretary for Human Development for records of the Office of Human Development. (v) Commissioner of Social Security for records of the Social Security Ad- ministration. (vi) Administrator, Social and Reha- bilitation Service for the records of the Social and Rehabilitation Service. (2) An appeal will be completed with- in 30 working days from its receipt by the appeal authority; except that, the appeal authority may for good cause extend this period for an additional 30 days. Should the appeal period be ex- tended, the subject individual appeal- ing the the appeal authority; except that, the appeal authority may for good cause extend this period for an additional 30 days. Should the appeal period be ex- tended, the subject individual appeal- ing the refusal to correct or amend the record will be informed in writing of the extension and the circumstances of 40 Dept. of Health and Human Services § 5b.9 the delay. The subject individual’s re- quest to amend or correct the record, the responsible Department official’s refusal to correct or amend, and any other pertinent material relating to the appeal will be reviewed. No hearing will be held. (3) If the appeal authority agrees that the record subject to the appeal should be corrected or amended, the record will be amended and the subject individual will be informed in writing of the correction or amendment. Where an accounting was made of prior disclo- sures of the record, all previous recipi- ents of the record will be informed of the corrective action taken. (4) If the appeal is denied, the subject individual will be informed in writing: (i) Of the denial and the reasons for the denial; (ii) That he has a right to seek judi- cial review of the denial; and, (iii) That he may submit , the subject individual will be informed in writing: (i) Of the denial and the reasons for the denial; (ii) That he has a right to seek judi- cial review of the denial; and, (iii) That he may submit to the re- sponsible Department official a concise statement of disagreement to be asso- ciated with the disputed record and dis- closed whenever the record is disclosed. (b) Notation and disclosure of disputed records. Whenever a subject individual submits a statement of disagreement to the responsible Department official in accordance with paragraph (a)(4)(iii) of this section, the record will be noted to indicate that it is disputed. In any subsequent disclosure, a copy of the subject individual’s statement of dis- agreement will be disclosed with the record. If the responsible Department official deems it appropriate, a concise statement of the appeal authority’s reasons for denying the subject individ- ual’s appeal may also be disclosed with the record. While the subject indi- vidual will have access to this state- ment of reasons, such statement will not be subject to correction or amend- ment. Where an accounting was made of prior disclosures of the record, all previous recipien will have access to this state- ment of reasons, such statement will not be subject to correction or amend- ment. Where an accounting was made of prior disclosures of the record, all previous recipients of the record will be provided a copy of the subject indi- vidual’s statement of disagreement, as well as the statement, if any, of the ap- peal authority’s reasons for denying the subject individual’s appeal. § 5b.9 Disclosure of records. (a) Consent to disclosure by a subject individual. (1) Except as provided in paragraph (b) of this section author- izing disclosures of records without consent, no disclosure of a record will be made without the consent of the subject individual. In each case the consent, whether obtained from the subject individual at the request of the Department or whether provided to the Department by the subject individual on his own initiative, shall be in writ- ing. The consent shall specify the indi- vidual, organizational unit or class of individuals or organizational units to whom the record may be disclosed, which record may be disclosed and, where applicable, during which time frame the record may be disclosed (e.g., during the school year, while the s izational units to whom the record may be disclosed, which record may be disclosed and, where applicable, during which time frame the record may be disclosed (e.g., during the school year, while the sub- ject individual is out of the country, whenever the subject individual is re- ceiving specific services). A blanket consent to disclose all of a subject indi- vidual’s records to unspecified individ- uals or organizational units will not be honored. The subject individual’s iden- tity and, where applicable (e.g., where a subject individual gives consent to dis- closure of a record to a specific indi- vidual), the identity of the individual to whom the record is to be disclosed shall be verified. (2) A parent or guardian of any minor is not authorized to give consent to a disclosure of the minor’s medical record. (b) Disclosures without the consent of the subject individual. The disclosures listed in this paragraph may be made without the consent of the subject indi- vidual. Such disclosures are: (1) To those officers and employees of the Department who have a need for the record in the performance of their duties. The responsible Department of- ficial may upon request of any office sures are: (1) To those officers and employees of the Department who have a need for the record in the performance of their duties. The responsible Department of- ficial may upon request of any officer or employee, or on his own initiative, determine what constitutes legitimate need. (2) Required to be disclosed under the Freedom of Information Act, 5 U.S.C. 552, and part 5 of this title. (3) For a routine use as defined in paragraph (j) of § 5b.1 of this part. Rou- tine uses will be listed in any notice of a system of records. Routine uses pub- lished in appendix B are applicable to more than one system of records. Where applicable, notices of systems of records may contain references to the 41 § 5b.10 45 CFR Subtitle A (10–1–24 Edition) routine uses listed in appendix B. Ap- pendix B will be published with any compendium of notices of systems of records. (4) To the Bureau of the Census for purposes of planning or carrying out a census or survey or related activity pursuant to the provisions of Title 13 U.S.C. (5) To a recipient who has provided the agency with advance written assur- ance that the record will be used solely as a statistical research or reporting record; Provided, visions of Title 13 U.S.C. (5) To a recipient who has provided the agency with advance written assur- ance that the record will be used solely as a statistical research or reporting record; Provided, That, the record is transferred in a form that does not identify the subject individual. (6) To the National Archives of the United States as a record which has sufficient historical or other value to warrant its continued preservation by the United States Government, or for evaluation by the Administrator of General Services or his designee to de- termine whether the record has such value. (7) To another government agency or to an instrumentality of any govern- mental jurisdiction within or under the control of the United States for a civil or criminal law enforcement activity if the activity is authorized by law, and if the head of such government agency or instrumentality has submitted a writ- ten request to the Department speci- fying the record desired and the law en- forcement activity for which the record is sought. (8) To an individual pursuant to a showing of compelling circumstances affecting the health or safety of any in- dividual if a notice of the disclosure is transmitte ty for which the record is sought. (8) To an individual pursuant to a showing of compelling circumstances affecting the health or safety of any in- dividual if a notice of the disclosure is transmitted to the last known address of the subject individual. (9) To either House of Congress, or to the extent of matter within its juris- sub- diction, any committee thereof, any joint com- mittee of Congress or subcommittee of any such joint committee. committee or (10) To the Comptroller General, or any of his authorized representatives, in the course of the performance of the duties of the General Accounting Of- fice. (11) Pursuant to the order of a court of competent jurisdiction. (c) Accounting of disclosures. (1) An ac- counting of all disclosures of a record will be made and maintained by the Department for 5 years or for the life of the record, whichever is longer; except that, such an accounting will not be made: (i) For disclosures under paragraphs (b) (1) and (2) of this section; and, (ii) For disclosures made with the written consent of the subject indi- vidual. (2) The accounting will include: (i) The date, nature, and purpose of each disclosure; and (ii) The name and address o