81 FR 56656 - Adapting Regulatory Oversight of Next Generation Sequencing-Based Tests; Public Workshop; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 162 (August 22, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 162 (August 22, 2016)
| Page Range | 56656-56658 | |
| FR Document | 2016-19939 |
[Federal Register Volume 81, Number 162 (Monday, August 22, 2016)] [Notices] [Pages 56656-56658] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-19939] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-2473] Adapting Regulatory Oversight of Next Generation Sequencing-Based Tests; Public Workshop; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Adapting Regulatory Oversight of Next Generation Sequencing-Based Tests.'' The purpose of this workshop is to obtain feedback on two FDA draft guidances, ``Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases'' and ``Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics'' that describes new approaches to regulate NGS-based tests. DATES: The public workshop will be held on September 23, 2016, from 9 a.m.to 3 p.m. Submit either electronic or written comments on the public workshop by October 6, 2016. ADDRESSES: The workshop will be held in Masur Auditorium at the NIH Campus, 9000 Rockville Pike, Bldg. 10, Bethesda, MD 20814. For parking and security information, please refer to the NIH Campus Visitor Information: http://www.nih.gov/icd/od/ocpl/VIC/index.htm. You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2016-N-2473 for ``Adapting Regulatory Oversight of Next Generation Sequencing-Based Tests.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The [[Page 56657]] second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: David Litwack, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4548, Silver Spring, MD 20993, 301-796-6206, [email protected]. SUPPLEMENTARY INFORMATION: I. Background In Vitro diagnostic devices that utilize NGS technology to generate information on an individual's genome are rapidly transforming healthcare. As part of the Precision Medicine Initiative,\1\ FDA is developing and implementing a novel framework for NGS test regulation that can accelerate innovation while assuring NGS-based test safety and effectiveness. To advance this effort, FDA published two draft guidances on July 8, 2016. The first, entitled ``Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics'', describes how publicly accessible databases of human genetic variants can serve as sources of valid scientific evidence to support the clinical validity of genotype-phenotype relationships in FDA's regulatory review of NGS- based tests. This draft guidance further outlines the process by which administrators of genetic variant databases could voluntarily apply to FDA for recognition, and how FDA would review such applications and periodically reevaluate recognized databases. --------------------------------------------------------------------------- \1\ The Precision Medicine Initiative found on the White House's Web site at: https://www.whitehouse.gov/precision-medicine. --------------------------------------------------------------------------- The second draft guidance document, entitled ``Use of Standards in the Food and Drug Administration's Regulatory Oversight of Next Generation Sequencing-Based In Vitro Diagnostics Used for Diagnosing Germline Diseases'', addresses DNA sequencing and whole exome sequencing NGS-based tests intended to aid in the diagnosis of individuals with suspected germline diseases or other conditions. This document provides recommendations for designing, developing, and validating NGS-based tests for germline diseases, and also discusses possible use of FDA-recognized standards for regulatory oversight of these tests. These recommendations are based on FDA's understanding of the tools and processes needed to run an NGS-based test along with the design and analytical validation considerations appropriate for such tests. Neither draft guidance is final nor in effect at this time. The workshop announced in this document seeks to obtain public input on the proposals contained in the two draft guidances. Workshop material, including the draft guidances, can be accessed from the workshop Web site: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list). II. Topics for Discussion at the Public Workshop This public workshop will consist of presentations that will frame the goals of the workshop followed by moderated discussions via panel sessions. The presentations and discussions will focus on the content of the draft guidances, as well as on additional questions that were posed in the Notices of Availability published in the Federal Register on July 8, 2016. These notices can be found at https://federalregister.gov/a/2016-1233 and https://federalregister.gov/a/2016-1270. Registration: Registration is free and available on a first-come, first-served basis. Persons interested in attending this public workshop must register online by September 13, 2016, at 4 p.m. Early registration is recommended because facilities are limited and, therefore, FDA may limit the number of participants from each organization. If time and space permits, onsite registration on the day of the public workshop will be provided beginning at 8 a.m. If you need special accommodations due to a disability, please contact Susan Monahan, 301-796-5661, [email protected], no later than September 12, 2016. To register for the public workshop, please visit FDA's Medical Devices News, Events, Workshops, and Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.) Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone number. Those without Internet access should contact David Litwack to register (see FOR FURTHER INFORMATION CONTACT). Registrants will receive confirmation after they have been accepted. You will be notified if you are on a waiting list. Streaming Webcast of the Public Workshop: This public workshop will also be Webcast. The Webcast link will be available on the registration Web site after September 13, 2016. To view the registration Web site, please visit FDA's Medical Devices News, Events, Workshops, and Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. Select this public workshop from the posted events list. FDA has verified the Web site addresses in this document, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. Requests for Oral Presentations: This public workshop includes a public comment session. During online registration you may indicate if you wish to present during a public comment session, and which topics you wish to address. In addition to the subjects discussed in the two draft guidances, FDA has posed supplemental topics in the Notices of Availability for the draft guidances (see Supplementary Information). FDA will do its best to accommodate requests to make public comments. Individuals and organizations with common interests are urged to consolidate or coordinate their comments, and request time for joint comments, or submit requests for designated representatives to participate in the focused sessions. Following the close of registration, FDA will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, [[Page 56658]] and will select and notify participants by September 14, 2016. All requests to make oral presentations must be received by September 13, 2016. If selected for presentation, any presentation materials must be emailed to David Litwack (see FOR FURTHER INFORMATION CONTACT) no later than September 16, 2016, at 5 p.m. No commercial or promotional material will be permitted to be presented or distributed at the public workshop. FDA is holding this public workshop to obtain feedback on its recently released draft guidance documents: ``Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing-Based In Vitro Diagnostics'' and ``Use of Standards in the Food and Drug Administration's Regulatory Oversight of Next Generation Sequencing-Based In Vitro Diagnostics Used for Diagnosing Germline Diseases''. In order to permit the widest possible opportunity to obtain public comment, FDA is soliciting either electronic or written comments on all aspects of the public workshop topics. The deadline for submitting comments related to this public workshop is October 6, 2016. Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at http://www.regulations.gov. It may be viewed at the Division of Dockets Management (see ADDRESSES). A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. The Freedom of Information office address is available on the Agency's Web site at http://www.fda.gov. A link to the transcripts will also be available approximately 45 days after the public workshop on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.) Dated: August 17, 2016. Peter Lurie, Associate Commissioner for Public Health Strategy and Analysis. [FR Doc. 2016-19939 Filed 8-19-16; 8:45 am] BILLING CODE 4164-01-P
![56656 Federal Register / Vol. 81, No. 162 / Monday, August 22, 2016 / Notices
It is expected that ORR will continue 29, 2015, in FR Doc. 2015–32726, the instructions for submitting comments.
to provide awards to the listed grantees following correction is made: Comments submitted electronically,
for a 4-year project period. Grantees will 1. On page 81336, in the third including attachments, to http://
be required to submit applications for column, in the 13th sentence of the www.regulations.gov will be posted to
noncompetitive awards for the second paragraph under section II. the docket unchanged. Because your
subsequent years of the project period. CDRH Guidance Development Initiative, comment will be made public, you are
Future noncompetitive awards will be ‘‘2 years’’ is corrected to read ‘‘3 years’’. solely responsible for ensuring that your
based on the grantee’s performance, the Dated: August 16, 2016. comment does not include any
availability of funds, and the best Peter Lurie, confidential information that you or a
interest of the Federal Government. Associate Commissioner for Public Health
third party may not wish to be posted,
Statutory Authority: The Refugee Act of Strategy and Analysis. such as medical information, your or
1980 as amended, Wilson-Fish Amendment, [FR Doc. 2016–19874 Filed 8–19–16; 8:45 am]
anyone else’s Social Security number, or
Public Law 98–473, 8 U.S.C. 1522(e)(7); confidential business information, such
BILLING CODE 4164–01–P
section 412(e)(7)(A) of the Immigration and as a manufacturing process. Please note
Nationality Act. that if you include your name, contact
DEPARTMENT OF HEALTH AND information, or other information that
Mary M. Wayland,
HUMAN SERVICES identifies you in the body of your
Senior Grants Policy Specialist, Division of comments, that information will be
Grants Policy, Office of Administration.
Food and Drug Administration posted on http://www.regulations.gov.
[FR Doc. 2016–19923 Filed 8–19–16; 8:45 am] • If you want to submit a comment
BILLING CODE 4184–01–P [Docket No. FDA–2016–N–2473] with confidential information that you
do not wish to be made available to the
Adapting Regulatory Oversight of Next
public, submit the comment as a
DEPARTMENT OF HEALTH AND Generation Sequencing-Based Tests;
Public Workshop; Request for written/paper submission and in the
HUMAN SERVICES manner detailed (see ‘‘Written/Paper
Comments
Submissions’’ and ‘‘Instructions’’).
Food and Drug Administration AGENCY: Food and Drug Administration,
Written/Paper Submissions
[Docket No. FDA–2012–N–1021] HHS.
ACTION: Notice of public workshop; Submit written/paper submissions as
Medical Device User Fee and request for comments. follows:
Modernization Act; Notice to Public of • Mail/Hand delivery/Courier (for
Web Site Location of Fiscal Year 2016 SUMMARY: The Food and Drug written/paper submissions): Division of
Proposed Guidance Development; Administration (FDA) is announcing the Dockets Management (HFA–305), Food
Correction following public workshop entitled and Drug Administration, 5630 Fishers
‘‘Adapting Regulatory Oversight of Next Lane, Rm. 1061, Rockville, MD 20852.
AGENCY: Food and Drug Administration, Generation Sequencing-Based Tests.’’ • For written/paper comments
HHS The purpose of this workshop is to submitted to the Division of Dockets
ACTION: Notice; correction. obtain feedback on two FDA draft Management, FDA will post your
guidances, ‘‘Use of Standards in FDA comment, as well as any attachments,
SUMMARY: The Food and Drug Regulatory Oversight of Next Generation except for information submitted,
Administration is correcting a notice Sequencing (NGS)-Based In Vitro marked and identified, as confidential,
entitled ‘‘Medical Device User Fee and Diagnostics (IVDs) Used for Diagnosing if submitted as detailed in
Modernization Act; Notice to Public of Germline Diseases’’ and ‘‘Use of Public ‘‘Instructions.’’
Web Site Location of Fiscal Year 2016 Human Genetic Variant Databases to Instructions: All submissions received
Proposed Guidance Development’’ that Support Clinical Validity for Next must include the Docket No. FDA–
appeared in the Federal Register of Generation Sequencing (NGS)-Based In 2016–N–2473 for ‘‘Adapting Regulatory
December 29, 2016 (80 FR 81335). The Vitro Diagnostics’’ that describes new Oversight of Next Generation
document announced the Web site approaches to regulate NGS-based tests. Sequencing-Based Tests.’’ Received
location where the Agency will post two comments will be placed in the docket
DATES: The public workshop will be
lists of guidance documents that the and, except for those submitted as
Center for Devices and Radiological held on September 23, 2016, from 9
a.m.to 3 p.m. Submit either electronic or ‘‘Confidential Submissions,’’ publicly
Health (CDRH or the Center) intends to viewable at http://www.regulations.gov
publish in Fiscal Year (FY) 2016. The written comments on the public
workshop by October 6, 2016. or at the Division of Dockets
document was published with the Management between 9 a.m. and 4 p.m.,
incorrect number of years in which ADDRESSES: The workshop will be held
in Masur Auditorium at the NIH Monday through Friday.
CDRH committed to finalize, withdraw, • Confidential Submissions—To
re-open the comment period, or issue Campus, 9000 Rockville Pike, Bldg. 10,
Bethesda, MD 20814. For parking and submit a comment with confidential
another draft guidance on the topic for information that you do not wish to be
80 percent of the documents. This security information, please refer to the
NIH Campus Visitor Information: http:// made publicly available, submit your
document corrects that error. comments only as a written/paper
www.nih.gov/icd/od/ocpl/VIC/
FOR FURTHER INFORMATION CONTACT: Lisa submission. You should submit two
asabaliauskas on DSK3SPTVN1PROD with NOTICES
index.htm.
Granger, Office of Policy, Planning, You may submit comments as copies total. One copy will include the
Legislation, and Analysis, Food and follows: information you claim to be confidential
Drug Administration, 10903 New with a heading or cover note that states
Hampshire Ave., Bldg. 32, Rm. 3330, Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
Silver Spring, MD 20993–0002, 301– Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
796–9115. following way: Agency will review this copy, including
SUPPLEMENTARY INFORMATION: In the • Federal eRulemaking Portal: http:// the claimed confidential information, in
Federal Register of Tuesday, December www.regulations.gov. Follow the its consideration of comments. The
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![56658 Federal Register / Vol. 81, No. 162 / Monday, August 22, 2016 / Notices
and will select and notify participants DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND
by September 14, 2016. All requests to HUMAN SERVICES HUMAN SERVICES
make oral presentations must be
received by September 13, 2016. If Food and Drug Administration Food and Drug Administration
selected for presentation, any [Docket No. FDA–2016–N–2474]
presentation materials must be emailed [Docket No. FDA–2016–N–0001]
to David Litwack (see FOR FURTHER Agency Information Collection
INFORMATION CONTACT) no later than National Mammography Quality Activities; Proposed Collection;
September 16, 2016, at 5 p.m. No Assurance Advisory Committee; Comment Request; Reporting
commercial or promotional material Amendment of Notice Associated With Designated New
will be permitted to be presented or Animal Drugs for Minor Use and Minor
distributed at the public workshop. AGENCY: Food and Drug Administration, Species
HHS.
FDA is holding this public workshop AGENCY: Food and Drug Administration,
to obtain feedback on its recently ACTION: Notice. HHS.
released draft guidance documents: ACTION: Notice.
‘‘Use of Public Human Genetic Variant SUMMARY: The Food and Drug
Databases to Support Clinical Validity Administration (FDA) is announcing an SUMMARY: The Food and Drug
for Next Generation Sequencing-Based amendment to the notice of meeting of Administration (FDA) is announcing an
In Vitro Diagnostics’’ and ‘‘Use of the National Mammography Quality opportunity for public comment on the
Standards in the Food and Drug Assurance Advisory Committee. This proposed collection of certain
Administration’s Regulatory Oversight meeting was announced in the Federal information by the Agency. Under the
of Next Generation Sequencing-Based In Register of August 5, 2016. The Paperwork Reduction Act of 1995 (the
amendment is being made to reflect a PRA), Federal Agencies are required to
Vitro Diagnostics Used for Diagnosing
change in the ADDRESSES portion of the publish notice in the Federal Register
Germline Diseases’’. In order to permit
document. There are no other changes. concerning each proposed collection of
the widest possible opportunity to
information, including each proposed
obtain public comment, FDA is FOR FURTHER INFORMATION CONTACT: S.J. extension of an existing collection of
soliciting either electronic or written Anderson, Center for Devices and information, and to allow 60 days for
comments on all aspects of the public Radiological Health, Food and Drug public comment in response to the
workshop topics. The deadline for Administration, 10903 New Hampshire notice. This notice solicits comments on
submitting comments related to this Ave., Bldg. 66, Rm. 1552, Silver Spring, the reporting associated with
public workshop is October 6, 2016. MD 20993–0002, Sara.Anderson@ designation under the Minor Use and
Transcripts: Please be advised that as fda.hhs.gov, 301–796–6875, or FDA Minor Species Animal Health Act of
soon as a transcript is available, it will Advisory Committee Information Line, 2004.
be accessible at http:// 1–800–741–8138 (301–443–0572 in the DATES: Submit either electronic or
www.regulations.gov. It may be viewed Washington, DC area), code MA. Please written comments on the collection of
at the Division of Dockets Management call the Information Line for up-to-date information by October 21, 2016.
(see ADDRESSES). A transcript will also information on this meeting. ADDRESSES: You may submit comments
be available in either hardcopy or on SUPPLEMENTARY INFORMATION: In the as follows:
CD–ROM, after submission of a Federal Register of August 5, 2016 (81
Freedom of Information request. A Electronic Submissions
FR 51918), FDA announced that a
transcript will also be available in either meeting of the National Mammography Submit electronic comments in the
hardcopy or on CD–ROM, after Quality Assurance Advisory Committee following way:
submission of a Freedom of Information would be held on September 15, 2016. • Federal eRulemaking Portal: http://
request. The Freedom of Information On page 51919, in the first column, in www.regulations.gov. Follow the
office address is available on the the ADDRESSES portion: Hilton instructions for submitting comments.
Agency’s Web site at http:// Comments submitted electronically,
Washington, DC/North, Salons A, B, C
www.fda.gov. A link to the transcripts including attachments, to http://
and D, 620 Perry Pkwy., Gaithersburg,
will also be available approximately 45 www.regulations.gov will be posted to
MD 20877. The hotel’s telephone
days after the public workshop on the the docket unchanged. Because your
number is 301–977–8900, is changed to comment will be made public, you are
Internet at http://www.fda.gov/ read as follows: Gaithersburg Holiday
MedicalDevices/NewsEvents/ solely responsible for ensuring that your
Inn—Grand Ballroom, 2 Montgomery comment does not include any
WorkshopsConferences/default.htm. Village Ave., Gaithersburg, MD 20878.
(Select this public workshop from the confidential information that you or a
The hotel’s telephone number is 301– third party may not wish to be posted,
posted events list.) 948–8900. such as medical information, your or
Dated: August 17, 2016. This notice is issued under the anyone else’s Social Security number, or
Peter Lurie, Federal Advisory Committee Act (5 confidential business information, such
U.S.C. app. 2) and 21 CFR part 14, as a manufacturing process. Please note
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Associate Commissioner for Public Health
Strategy and Analysis. relating to the advisory committees. that if you include your name, contact
[FR Doc. 2016–19939 Filed 8–19–16; 8:45 am] Dated: August 17, 2016.
information, or other information that
BILLING CODE 4164–01–P
identifies you in the body of your
Janice M. Soreth, comments, that information will be
Acting Associate Commissioner, Special posted on http://www.regulations.gov.
Medical Programs. • If you want to submit a comment
[FR Doc. 2016–19957 Filed 8–19–16; 8:45 am] with confidential information that you
BILLING CODE 4164–01–P do not wish to be made available to the
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Document Created: 2018-02-09 11:37:45
Document Modified: 2018-02-09 11:37:45
| 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 | Notices | |
| Action | Notice of public workshop; request for comments. | |
| Dates | The public workshop will be held on September 23, 2016, from 9 a.m.to 3 p.m. Submit either electronic or written comments on the public workshop by October 6, 2016. | |
| Contact | David Litwack, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4548, Silver Spring, MD 20993, 301-796-6206, [email protected] | |
| FR Citation | 81 FR 56656 |
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