82 FR 6423 - National Vaccine Injury Compensation Program: Statement of Reasons for Not Conducting a Rulemaking Proceeding
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 82, Issue 12 (January 19, 2017)
Health Resources and Services Administration
Federal Register Volume 82, Issue 12 (January 19, 2017)
| Page Range | 6423-6425 | |
| FR Document | 2017-00700 |
[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)] [Proposed Rules] [Pages 6423-6425] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-00700] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration 42 CFR Part 100 National Vaccine Injury Compensation Program: Statement of Reasons for Not Conducting a Rulemaking Proceeding AGENCY: Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Denial of petition for rulemaking. ----------------------------------------------------------------------- SUMMARY: In accordance with section 2114(c)(2)(B) of the Public Health Service Act, 42 U.S.C. 300aa-14(c)(2)(B), notice is hereby given concerning the reasons for not conducting a rulemaking proceeding to add neurological disorders or conditions as injuries associated with seasonal influenza vaccines to the Vaccine Injury Table. DATES: Written comments are not being solicited. FOR FURTHER INFORMATION CONTACT: Narayan Nair, MD, Director, Division of Injury Compensation Programs (DICP), Healthcare Systems Bureau, Health Resources and Services Administration, 5600 Fishers Lane, Room 8N146B, Rockville, Maryland 20857, or by telephone 301-443-6593. SUPPLEMENTARY INFORMATION: The National Childhood Vaccine Injury Act of 1986, (Vaccine Act), Title III of Public Law 99-660, established the National Vaccine Injury Compensation Program (VICP) for persons found to be injured by vaccines.\1\ Under this federal program, petitions for compensation are filed with the United States Court of Federal Claims (Court). The Court, acting through special masters, makes findings as to eligibility for, and amount of, compensation. To gain entitlement to compensation under VICP for a covered vaccine, a petitioner must establish a vaccine-related injury or death in one of the following ways (unless another cause is found): (1) By proving that the first symptom of an injury or condition, as defined by the Qualifications and Aids to Interpretation, occurred within the time period listed on the Vaccine Injury Table (Table), and, therefore, is presumed to be caused by a vaccine; (2) by proving vaccine causation, if the injury or condition is not on the Table or did not occur within the time period specified on the Table; or (3) by proving that the vaccine significantly aggravated a pre-existing condition. --------------------------------------------------------------------------- \1\ 42 U.S.C. 300 aa-10 et seq. --------------------------------------------------------------------------- The statute authorizing VICP provides for the inclusion of additional vaccines in VICP when they are recommended by the Centers for Disease Control and Prevention for routine administration to children.\2\ Consistent with section 13632(a)(3) of Public Law 103-66, the regulations governing VICP provide that such vaccines will be included in the Table as of the effective date of an excise tax to provide funds for the payment of compensation with respect to such vaccines.\3\ The statute authorizing VICP also authorizes the Secretary to create and modify a list of injuries, disabilities, illnesses, conditions, and deaths (and their associated time frames) associated with each category of vaccines included on the Table.\4\ Finally, the Vaccine Act provides that: --------------------------------------------------------------------------- \2\ Section 2114(e)(2) of the PHS Act, 42 U.S.C. 300aa-14(e)(2). \3\ 42 CFR 100.3(c)(8). \4\ Sections 2114(c) and 2114(e)(2) of the PHS Act, 42 U.S.C. 300aa-14(c) and 300aa-14(e)(2). [a]ny person (including the Advisory Commission on Childhood Vaccines) [the Commission] may petition the Secretary to propose regulations to amend the Vaccine Injury Table. Unless clearly frivolous, or initiated by the Commission, any such petition shall --------------------------------------------------------------------------- be referred to the Commission for its recommendations. Following-- (A) Receipt of any recommendation of the Commission, or (B) 180 days after the date of the referral to the Commission, whichever occurs first, the Secretary shall conduct a rule-making proceeding on the matters proposed in the petition or publish [[Page 6424]] in the Federal Register a statement or reasons for not conducting such proceeding.\5\ --------------------------------------------------------------------------- \5\ Section 2114(c)(2) of the PHS Act, 42 U.S.C. 300aa-14(c)(2). On January 28, 2016, a private citizen submitted a petition to the Department of Health and Human Services (HHS) requesting that: (1) Any adverse neurological disorder or condition be added to the Table for the seasonal influenza vaccines; and (2) if any adverse neurological disorder or condition was too broad in scope, then at least anaphylaxis, Shoulder Injury Related to Vaccine Administration (SIRVA), vasovagal syncope, multiple sclerosis (MS), Guillain-Barr[eacute] Syndrome (GBS), transverse myelitis (TM), and myelitis be added to the Table for the seasonal influenza vaccine. The petitioner asserted that based on Vaccine Adverse Event Reporting System (VAERS) data and Department of Justice (DOJ) quarterly reports on vaccine settlements, which were presented at Commission meetings, there is sufficient evidence to add these conditions as injuries associated with the seasonal influenza vaccine to the Table. The petitioner did not provide any medical or scientific literature to accompany the request. Pursuant to the Vaccine Act, the petition was referred to the Commission on June 3, 2016. The Commission voted unanimously to recommend that the Secretary not proceed with rulemaking to amend the Table to include ``any adverse neurological disorder or condition,'' MS, TM, or myelitis as injuries associated with seasonal influenza vaccines as requested in the petition. The petitioner requested the addition of any adverse neurological disorder or condition to the Table for the seasonal influenza vaccine. The petitioner alleged that the DOJ quarterly reports on vaccine settlement cases and VAERS data support the inclusion of all of these conditions to the Table. However, neither of these sources of data is sufficient to modify the Table. The DOJ quarterly report is the report that DOJ provides and discusses at the quarterly Commission meetings and is made available to the public at http://www.hrsa.gov/advisorycommittees/childhoodvaccines/meetings.html. The report includes a list of adjudicated settlements for the applicable quarter by vaccine and alleged injury, and time frame from petition filing to settlement filing. In negotiated settlements between the parties, HHS has not concluded, based upon review of the evidence, that the alleged vaccine(s) caused the alleged injury. These settlements are not an admission by the United States or the Secretary of Health and Human Services that the vaccine caused the petitioner's alleged injury, and, in settled cases, the Court does not determine that the vaccine caused the injury. Therefore, a settlement cannot be characterized as a decision by HHS or by the Court that the vaccine caused an injury. Thus, information from negotiated settlements cannot be used to establish that vaccines cause certain injuries. The purposes of VAERS data are to: Detect new, unusual, or rare vaccine adverse events; identify potential patient risk factors for particular types of adverse events; identify vaccine lots with increased numbers or types of reported adverse events; and assess the safety of newly licensed vaccines. The VAERS data are considered a useful tool in vaccine safety, but VAERS reports by themselves generally cannot demonstrate that vaccines cause injuries. In 2008, the Secretary contracted with the Institute of Medicine (IOM) to review the epidemiologic, clinical, and biological evidence regarding adverse health events associated with specific vaccines covered by VICP. The results of this review were published in the 2012 IOM Report, ``Adverse Effects of Vaccines: Evidence and Causality.'' This report reviewed 8 of the 12 vaccines covered by the VICP and provided 158 causality conclusions. The 2012 IOM Report reviewed the medical and scientific literature regarding a causal relationship between seasonal influenza vaccines and the following conditions: Encephalopathy, encephalitis, seizures, acute disseminated encephalomyelitis, TM, optic neuritis, neuromyelitis optica, MS, MS relapse, GBS, chronic inflammatory demyelinating polyneuropathy, Bell's palsy, brachial neuritis, and small fiber neuropathy. The IOM concluded that the evidence is inadequate to accept or reject a causal relationship between influenza vaccines and the above conditions. Therefore, ``any adverse neurological disorder or condition,'' as suggested by the petitioner will not be added as injuries caused by the seasonal influenza vaccine to the Table since the medical and scientific literature is not sufficient to support this change. The petitioner also requested that certain conditions be added to the Table if ``any adverse neurological disorder or condition'' could not be added to the Table. These conditions include: Anaphylaxis, SIRVA, vasovagal syncope, MS, GBS, TM, and myelitis. The petitioner stated that VAERS and settlement data from quarterly reports support the inclusion of these conditions for seasonal influenza vaccines to the Table. However, as explained above, the VAERS data and the DOJ quarterly report do not demonstrate that vaccines cause injuries and do not establish causality. As stated previously, the 2012 IOM Report reviewed the medical and scientific literature regarding causal relationships between seasonal influenza vaccines and MS, TM, and myelitis. The IOM concluded that the evidence is inadequate to accept or reject a causal relationship between influenza vaccines and these conditions. More recent studies support the lack of an association between the seasonal influenza vaccine and neurologic conditions, such as MS. The Williamson, et al. study found no substantiation to reports suggesting a link between MS and vaccines and that most of the studies that purported an increased risk of MS or relapse of MS after vaccination were small case series, which are methodologically less robust than other epidemiologic studies.\6\ In addition, Langer-Gould, et al. conducted a nested case control study that found no long-term association between vaccines and MS or other central nervous system acquired demyelinating syndromes.\7\ Therefore, MS, TM, and myelitis will not be added to the Table as injuries associated with the seasonal influenza vaccine since the medical and scientific literature is not sufficient to support those changes. --------------------------------------------------------------------------- \6\ Williamson et al. Vaccines in Multiple Sclerosis, Curr Neurol Neurosci Rep 2016 16:36. \7\ Langer-Gould et al., Vaccines and the risk of MS and other CNS Demyelinating Diseases, JAMA Neurol. 2014:71(12): 1506-13. --------------------------------------------------------------------------- HHS proposed certain changes to the Vaccine Injury Table in a Notice of Proposed Rulemaking (NPRM) published in the Federal Register on July 29, 2015 (80 Fed. Reg. 45132 (July 29, 2015)). Among other proposed changes, anaphylaxis, SIRVA, GBS, and vasovagal syncope were proposed to be added as injuries for seasonal influenza vaccines. HHS is adding these injuries with the final rule, titled ``National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table,'' concurrently publishing in the Federal Register. In conclusion, there is no reliable evidence to support the addition of ``any adverse neurological disorder or condition,'' MS, TM, or myelitis to the Table as injuries associated with the seasonal influenza vaccine. Therefore, the Table will not be amended at this time to include those injuries on the Table. [[Page 6425]] Dated: January 9, 2017. Sylvia M. Burwell, Secretary, Department of Health and Human Services. [FR Doc. 2017-00700 Filed 1-18-17; 8:45 am] BILLING CODE 4165-15-P
![Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules 6423
Region 10 Office (please contact the impose substantial direct costs on tribal Vaccine Injury Compensation Program
person identified in the FOR FURTHER governments or preempt tribal law. This (VICP) for persons found to be injured
INFORMATION CONTACT section of this SIP revision is not approved to apply in by vaccines.1 Under this federal
preamble for more information). Indian reservations in the State, or any program, petitions for compensation are
other area where the EPA or an Indian filed with the United States Court of
V. Statutory and Executive Order
tribe has demonstrated that a tribe has Federal Claims (Court). The Court,
Reviews
jurisdiction. acting through special masters, makes
Under the CAA, the Administrator is findings as to eligibility for, and amount
required to approve a SIP submission List of Subjects in 40 CFR Part 52
of, compensation. To gain entitlement to
that complies with the provisions of the Environmental protection, Air compensation under VICP for a covered
CAA and applicable Federal regulations. pollution control, Carbon monoxide, vaccine, a petitioner must establish a
42 U.S.C. 7410(k); 40 CFR 52.02(a). Incorporation by reference, vaccine-related injury or death in one of
Thus, in reviewing SIP submissions, the Intergovernmental relations, Lead, the following ways (unless another
EPA’s role is to approve state choices, Nitrogen dioxide, Ozone, Particulate cause is found): (1) By proving that the
provided that they meet the criteria of matter, Reporting and recordkeeping first symptom of an injury or condition,
the CAA. Accordingly, this proposed requirements, Sulfur oxides, Volatile as defined by the Qualifications and
action merely approves the state’s law organic compounds. Aids to Interpretation, occurred within
as meeting Federal requirements and Authority: 42 U.S.C. 7401 et seq. the time period listed on the Vaccine
does not impose additional Injury Table (Table), and, therefore, is
Dated: January 4, 2017.
requirements beyond those imposed by presumed to be caused by a vaccine; (2)
the state’s law. For that reason, this Dennis J. McLerran,
by proving vaccine causation, if the
proposed action: Regional Administrator, Region 10. injury or condition is not on the Table
• Is not a ‘‘significant regulatory [FR Doc. 2017–01090 Filed 1–18–17; 8:45 am] or did not occur within the time period
action’’ subject to review by the Office BILLING CODE 6560–50–P specified on the Table; or (3) by proving
of Management and Budget under that the vaccine significantly aggravated
Executive Order 12866 (58 FR 51735, a pre-existing condition.
October 4, 1993); DEPARTMENT OF HEALTH AND
• Does not impose an information The statute authorizing VICP provides
HUMAN SERVICES for the inclusion of additional vaccines
collection burden under the provisions
of the Paperwork Reduction Act (44 Health Resources and Services in VICP when they are recommended by
U.S.C. 3501 et seq.); Administration the Centers for Disease Control and
• Is certified as not having a Prevention for routine administration to
significant economic impact on a 42 CFR Part 100 children.2 Consistent with section
substantial number of small entities 13632(a)(3) of Public Law 103–66, the
under the Regulatory Flexibility Act (5 National Vaccine Injury Compensation regulations governing VICP provide that
U.S.C. 601 et seq.); Program: Statement of Reasons for such vaccines will be included in the
• Does not contain any unfunded Not Conducting a Rulemaking Table as of the effective date of an
mandate or significantly or uniquely Proceeding excise tax to provide funds for the
affect small governments, as described payment of compensation with respect
AGENCY: Health Resources and Services to such vaccines.3 The statute
in the Unfunded Mandates Reform Act
Administration (HRSA), Department of authorizing VICP also authorizes the
of 1995 (Pub. L. 104–4);
Health and Human Services (HHS).
• Does not have Federalism Secretary to create and modify a list of
implications as specified in Executive ACTION: Denial of petition for injuries, disabilities, illnesses,
Order 13132 (64 FR 43255, August 10, rulemaking. conditions, and deaths (and their
1999); associated time frames) associated with
SUMMARY: In accordance with section
• Is not an economically significant 2114(c)(2)(B) of the Public Health
each category of vaccines included on
regulatory action based on health or the Table.4 Finally, the Vaccine Act
Service Act, 42 U.S.C. 300aa–
safety risks subject to Executive Order provides that:
14(c)(2)(B), notice is hereby given
13045 (62 FR 19885, April 23, 1997); concerning the reasons for not [a]ny person (including the Advisory
• Is not a significant regulatory action conducting a rulemaking proceeding to Commission on Childhood Vaccines) [the
subject to Executive Order 13211 (66 FR add neurological disorders or conditions Commission] may petition the Secretary to
28355, May 22, 2001); as injuries associated with seasonal propose regulations to amend the Vaccine
• Is not subject to the requirements of Injury Table. Unless clearly frivolous, or
influenza vaccines to the Vaccine Injury initiated by the Commission, any such
section 12(d) of the National
Table. petition shall be referred to the Commission
Technology Transfer and Advancement
DATES: Written comments are not being for its recommendations. Following—
Act of 1995 (15 U.S.C. 272 note) because
this action does not involve technical solicited. (A) Receipt of any recommendation of the
standards; and FOR FURTHER INFORMATION CONTACT: Commission, or
• Does not provide the EPA with the Narayan Nair, MD, Director, Division of (B) 180 days after the date of the referral
discretionary authority to address, as Injury Compensation Programs (DICP), to the Commission,
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
appropriate, disproportionate human Healthcare Systems Bureau, Health whichever occurs first, the Secretary shall
health or environmental effects, using Resources and Services Administration, conduct a rule-making proceeding on the
5600 Fishers Lane, Room 8N146B, matters proposed in the petition or publish
practicable and legally permissible
methods, under Executive Order 12898 Rockville, Maryland 20857, or by
1 42 U.S.C. 300 aa–10 et seq.
(59 FR 7629, February 16, 1994). telephone 301–443–6593.
2 Section 2114(e)(2) of the PHS Act, 42 U.S.C.
In addition, this rule does not have SUPPLEMENTARY INFORMATION: The
300aa–14(e)(2).
tribal implications as specified by National Childhood Vaccine Injury Act 3 42 CFR 100.3(c)(8).
Executive Order 13175 (65 FR 67249, of 1986, (Vaccine Act), Title III of Public 4 Sections 2114(c) and 2114(e)(2) of the PHS Act,
November 9, 2000), because it will not Law 99–660, established the National 42 U.S.C. 300aa–14(c) and 300aa–14(e)(2).
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![Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules 6425
Dated: January 9, 2017. Comments received generally will be 3024.70, Privacy Training and HSAR
Sylvia M. Burwell, posted without change to http:// 3052.224–7X, Privacy Training.
Secretary, Department of Health and Human www.regulations.gov, including any (2) Add a new subpart at HSAR
Services. personal information provided. To 3024.70, Privacy Training addressing
[FR Doc. 2017–00700 Filed 1–18–17; 8:45 am] confirm receipt of your comment(s), the requirements for privacy training.
BILLING CODE 4165–15–P please check http:// HSAR 3024.7001, Scope identifies the
www.regulations.gov, approximately applicability of the subpart to contracts
two to three days after submission to and subcontracts. HSAR 3024.7002,
verify posting (except allow 30 days for Definitions defines the term ‘‘handling.’’
DEPARTMENT OF HOMELAND posting of comments submitted by The definition of ‘‘handling’’ was
SECURITY mail). developed based upon a review of
48 CFR Parts 3001, 3002, 3024, and FOR FURTHER INFORMATION CONTACT: Ms.
definitions for the term developed by
Candace Lightfoot, Procurement other Federal agencies. HSAR
3052
Analyst, DHS, Office of the Chief 3024.7003, Policy identifies when
[Docket No. DHS–2017–0008] Procurement Officer, Acquisition Policy contractors and subcontracts are
and Legislation at (202) 447–0882 or required to complete the DHS privacy
RIN 1601–AA79 training. This subsection also requires
email HSAR@hq.dhs.gov. When using
email, include HSAR Case 2015–003 in the submission of training completion
Homeland Security Acquisition
the ‘‘Subject’’ line. certificates for all contractor and
Regulation (HSAR); Privacy Training
subcontractor employees as a record of
(HSAR Case 2015–003) SUPPLEMENTARY INFORMATION:
compliance. HSAR 3024.7004, Contract
AGENCY: Office of the Chief Procurement I. Background Clause, identifies when Contracting
Officer, Department of Homeland DHS contracts currently require Officers must insert HSAR 3052.224–7X
Security (DHS). contractor and subcontractor employees Privacy Training in solicitations and
ACTION: Proposed rule. to complete privacy training before contracts. DHS welcomes respondents
accessing a Government system of to offer their views on the following
SUMMARY: DHS is proposing to amend records; handling Personally questions in particular:
the Homeland Security Acquisition A. What burden, if any, is associated
Identifiable Information (PII) or
Regulation (HSAR) to add a new with the requirement to complete DHS-
Sensitive PII (SPII); or designing,
subpart, update an existing clause, and developed privacy training?
developing, maintaining, or operating a B. What value, if any, is associated
add a new contract clause to require Government system of records. This
contractors to complete training that with providing industry the flexibility
training is completed upon award of the to develop its own privacy training
addresses the protection of privacy, in procurement and at least annually
accordance with the Privacy Act of given a unique set of Government
thereafter. requirements?
1974, and the handling and DHS is proposing to (1) include
safeguarding of Personally Identifiable (3) Amend sub paragraph (b) of the
Privacy training requirements in the HSAR 3052.212–70, Contract Terms and
Information and Sensitive Personally HSAR and (2) make the training more Conditions Applicable to DHS
Identifiable Information. easily accessible by hosting it on a Acquisition of Commercial Items to add
DATES: Interested parties should submit public Web site. This approach ensures HSAR 3052.224–7X, Privacy Training.
written comments to one of the all applicable DHS contractors and This change is necessary because HSAR
addresses shown below on or before subcontractors are subject to the same 3052.224–7X is applicable to the
March 20, 2017, to be considered in the requirements while removing the need acquisition of commercial items; and
formation of the final rule. for Government intervention to provide (4) Add a new subsection at HSAR
ADDRESSES: Submit comments access to the Privacy training. 3052.224–7X, Privacy Training to
identified by HSAR Case 2015–003, This proposed rule standardizes the provide the text of the proposed clause.
Privacy Training, using any of the Privacy training requirement across all The proposed clause requires contractor
following methods: DHS contracts by amending the HSAR and subcontractor employees to
• Regulations.gov: http:// to: complete privacy training before
www.regulations.gov. (1) Add the terms ‘‘personally accessing a Government system of
Submit comments via the Federal identifiable information’’ and ‘‘sensitive records; handling Personally
eRulemaking portal by entering ‘‘HSAR personally identifiable information’’ at Identifiable Information (PII) or
Case 2015–003’’ under the heading HSAR 3002.1, Definitions. The Sensitive PII (SPII); or designing,
‘‘Enter Keyword or ID’’ and selecting definition of ‘‘personally identifiable developing, maintaining, or operating a
‘‘Search.’’ Select the link ‘‘Submit a information’’ is taken from OMB Government system of records. The
Comment’’ that corresponds with Circular A–130 Managing Information training shall be completed within
‘‘HSAR Case 2015–003.’’ Follow the as a Strategic Resource,1 published July thirty (30) days of contract award and
instructions provided at the ‘‘Submit a 27, 2016. The definition of ‘‘sensitive on an annual basis thereafter. The
Comment’’ screen. Please include your personally identifiable information’’ is contractor shall maintain copies of
name, company name (if any), and derived from the DHS lexicon, Privacy training certificates for all contractor
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
‘‘HSAR Case 2015–003’’ on your Incident Handling Guidance, and the and subcontractor employees as a record
attached document. Handbook for Safeguarding Sensitive of compliance and provide copies of the
• Fax: (202) 447–0520 Personally Identifiable Information. training certificates to the contracting
• Mail: Department of Homeland These definitions are necessary because officer. Subsequent training certificates
Security, Office of the Chief these terms appear in proposed HSAR to satisfy the annual privacy training
Procurement Officer, Acquisition Policy 1 OMB Circular A–130 Managing Information as
requirement shall be submitted via
and Legislation, ATTN: Ms. Candace a Strategic Resource is accessible at https://
email notification not later than October
Lightfoot, 245 Murray Drive, Bldg. 410 www.whitehouse.gov/sites/default/files/omb/assets/ 31st of each year. The contractor shall
(RDS), Washington, DC 20528. OMB/circulars/a130/a130revised.pdf. attach training certificates to the email
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Document Created: 2018-02-01 15:15:13
Document Modified: 2018-02-01 15:15:13
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Denial of petition for rulemaking. | |
| Dates | Written comments are not being solicited. | |
| Contact | Narayan Nair, MD, Director, Division of Injury Compensation Programs (DICP), Healthcare Systems Bureau, Health Resources and Services Administration, 5600 Fishers Lane, Room 8N146B, Rockville, Maryland 20857, or by telephone 301-443-6593. | |
| FR Citation | 82 FR 6423 |
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