82 FR 35532 - Cardiac Troponin Assays; Public Workshop; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 145 (July 31, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 145 (July 31, 2017)
| Page Range | 35532-35534 | |
| FR Document | 2017-16007 |
[Federal Register Volume 82, Number 145 (Monday, July 31, 2017)] [Notices] [Pages 35532-35534] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-16007] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-4179] Cardiac Troponin Assays; 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, the Agency, or we) is announcing the following public workshop entitled ``Cardiac Troponin Assays.'' The purpose of the workshop is to discuss the development of innovative troponin assays designed to aid in the diagnosis of myocardial infarction (MI) and additional clinical uses of these assays. The workshop is intended to enhance engagement with stakeholders to facilitate device development and to discuss scientific and regulatory challenges associated with the analytical and clinical validation methods for troponin assay devices. Public input and feedback gained through this workshop may aid in the development of science-based approaches to aid in the efficient development of innovative, safe and effective, troponin diagnostic assays, which may lead to better patient care. DATES: The public workshop will be held on November 28, 2017, from 8:30 a.m. to 5 p.m. Submit either electronic or written comments on this public workshop by November 27, 2017. See the SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: The public workshop will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, Rm. 1503 (The Great Room), Silver Spring, MD 20993. Entrance for the public workshop participants (non- FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before November 27, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of November 27, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, 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-2017-N-4179 for ``Cardiac Troponin Assays.'' Received comments, those filed in a timely manner (see ADDRESSES) will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov [[Page 35533]] or at the Dockets Management Staff 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 second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Paula Caposino, Food and Drug Administration, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 4644, Silver Spring, MD 20993, 301-796- 6160, [email protected]. SUPPLEMENTARY INFORMATION: I. Background Since first discovered, cardiac troponin has become increasingly valuable as a biomarker of MI. In 2007, the National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines and the Joint European Society of Cardiology, American College of Cardiology Foundation, American Heart Association, and the World Heart Federation Task Force Guidelines recommended the use of cardiac troponin as a biomarker for the diagnosis of MI when used in conjunction with clinical evidence of myocardial ischemia (Refs. 1 and 2). Cardiac troponin has also been recommended in current clinical guidelines as a prognostic marker in patients with symptoms of acute coronary syndrome with respect to mortality, MI, or ischemic events. These recommendations solidified troponin's importance in MI diagnosis and triage; at the same time, they formalized an adjustment in the clinical cutoffs and changed the way troponin results were interpreted and used. There is a lot of interest in developing innovative troponin assays that aid in the diagnosis of MI and to support additional clinical uses of these assays. We are holding this public workshop to discuss several topics of interest that are important for the development of innovative cardiac troponin assays. The goal of the workshop is to enhance engagement with stakeholders concerning the development and validation of innovative troponin assay devices. II. Topics for Discussion at the Public Workshop This public workshop will consist of brief presentations providing information to frame the discussion, followed by interactive panel discussions. Following the presentations, a moderated discussion is planned to ask speakers and additional panelists to provide their individual perspectives. Topics for discussion include: Clinical study design considerations and challenges Subgroup differences for troponin's clinical use (e.g., the need for sex-specific cutoffs) Reference range study design considerations and best practices for reference range study design and methods for calculating upper reference limits The use of deltas in the diagnosis of MI Point of care testing In light of the changes to how troponin is used clinically, there is a need to explore and discuss troponin assay device development and evaluation. We are soliciting comments and feedback from stakeholders regarding additional topics for FDA to consider for discussion. These comments can be submitted to the docket prior to the meeting (see ADDRESSES). We anticipate that the comments and discussion at this public workshop will help facilitate the development of innovative troponin devices and lessen regulatory burden. The ultimate goal is to facilitate the availability of innovative, safe and effective troponin assay devices for patient care. III. Participating in the Public Workshop Registration: To register for the public workshop, please visit FDA's Medical Devices News & Events--Workshops & 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. Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public workshop must register by November 17, 2017, by 4 p.m. Eastern Time. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted. If time and space permit, onsite registration on the day of the public workshop will be provided beginning at 7:30 a.m. We will let registrants know if registration closes before the day of the public workshop. If you need special accommodations due to a disability, please contact Susan Monahan, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4321, Silver Spring, MD 20993-0002, 301-796-5661, email: [email protected], no later than November 14, 2017. Requests for Oral Presentations: During online registration you may indicate if you wish to present during a public comment session, and which topic(s) you wish to address. We will do our best to accommodate requests to make public comments. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation. Following the close of registration, we will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and will select and notify participants by November 20, 2017. All requests to make oral presentations must be received by the close of registration on [[Page 35534]] November 17, 2017 by 4 p.m. If selected for presentation, any presentation materials must be emailed to Paula Caposino (see FOR FURTHER INFORMATION CONTACT) no later than November 21, 2017. No commercial or promotional material will be permitted to be presented or distributed at the public workshop. Streaming Webcast of the public workshop: This public workshop will also be Webcast. The Webcast link will be available on the registration Web page after November 21, 2017. Organizations are requested to register all participants, but to view using one connection per location. If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit http://www.adobe.com/go/connectpro_overview. 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. Transcripts: Please be advised that as soon as a transcript of the public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff (see ADDRESSES). A link to the transcript 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). IV. References The following references are on display in the Dockets Management Staff (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov. 1. ``National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines: Clinical Characteristics and Utilization of Biochemical Markers in Acute Coronary Syndromes.'' Circulation, 2007; 115, 356-375. 2. ``Universal Definition of Myocardial Infarction.'' Circulation, 2007: 116, 2634-2653. Dated: July 20, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-16007 Filed 7-28-17; 8:45 am] BILLING CODE 4164-01-P
![35532 Federal Register / Vol. 82, No. 145 / Monday, July 31, 2017 / Notices
• Building and leveraging existing Dated: July 21, 2017. Electronic comments must be submitted
community infrastructures for Seema Verma, on or before November 27, 2017. The
information, counseling, and assistance. Administrator, Centers for Medicare & https://www.regulations.gov electronic
• Drawing the program link between Medicaid Services. filing system will accept comments
outreach and education, promoting [FR Doc. 2017–15960 Filed 7–28–17; 8:45 am] until midnight Eastern Time at the end
consumer understanding of health care BILLING CODE 4120–01–P of November 27, 2017. Comments
coverage choices, and facilitating received by mail/hand delivery/courier
consumer selection/enrollment, which (for written/paper submissions) will be
in turn support the overarching goal of DEPARTMENT OF HEALTH AND considered timely if they are
improved access to quality care, HUMAN SERVICES postmarked or the delivery service
including preventive services, acceptance receipt is on or before that
envisioned under the Affordable Care Food and Drug Administration date.
Act. [Docket No. FDA–2017–N–4179] Electronic Submissions
The current members of the Panel are:
Kellan Baker, Associate Director, Center Cardiac Troponin Assays; Public Submit electronic comments in the
for American Progress; Robert Blancato, Workshop; Request for Comments following way:
• Federal eRulemaking Portal: Go to
President, Matz, Blancato & Associates; AGENCY: Food and Drug Administration, https://www.regulations.gov. Follow the
Dale Blasier, Professor of Orthopaedic HHS. instructions for submitting comments.
Surgery, Department of Orthopaedics, ACTION: Notice of public workshop; Comments submitted electronically,
Arkansas Children’s Hospital; Deborah request for comments. including attachments, to https://
Britt, Executive Director of Community
www.regulations.gov will be posted to
& Public Relations, Piedmont Fayette SUMMARY: The Food and Drug
Administration (FDA, the Agency, or the docket unchanged. Because your
Hospital; Deena Chisolm, Associate
we) is announcing the following public comment will be made public, you are
Professor of Pediatrics & Public Health,
workshop entitled ‘‘Cardiac Troponin solely responsible for ensuring that your
The Ohio State University, Nationwide
Assays.’’ The purpose of the workshop comment does not include any
Children’s Hospital; Josephine DeLeon,
is to discuss the development of confidential information that you or a
Director, Anti-Poverty Initiatives,
innovative troponin assays designed to third party may not wish to be posted,
Catholic Charities of California; Robert
aid in the diagnosis of myocardial such as medical information, your or
Espinoza, Vice President of Policy,
infarction (MI) and additional clinical anyone else’s Social Security number, or
Paraprofessional Healthcare Institute;
uses of these assays. The workshop is confidential business information, such
Louise Scherer Knight, Director, The
intended to enhance engagement with as a manufacturing process. Please note
Sidney Kimmel Comprehensive Cancer
stakeholders to facilitate device that if you include your name, contact
Center at Johns Hopkins; Roanne
development and to discuss scientific information, or other information that
Osborne-Gaskin, M.D., Senior Medical
and regulatory challenges associated identifies you in the body of your
Director, MDWise, Inc.; Cathy Phan,
with the analytical and clinical comments, that information will be
Outreach and Education Coordinator,
validation methods for troponin assay posted on https://www.regulations.gov.
Asian American Health Coalition DBA • If you want to submit a comment
HOPE Clinic; Kamilah Pickett, devices. Public input and feedback
gained through this workshop may aid with confidential information that you
Litigation Support, Independent do not wish to be made available to the
Contractor; Brendan Riley, Outreach in the development of science-based
approaches to aid in the efficient public, submit the comment as a
and Enrollment Coordinator, NC written/paper submission and in the
Community Health Center Association; development of innovative, safe and
effective, troponin diagnostic assays, manner detailed (see ‘‘Written/Paper
Alvia Siddiqi, Medicaid Managed Care Submissions’’ and ‘‘Instructions’’).
Community Network (MCCN) Medical which may lead to better patient care.
Director, Advocate Physician Partners, DATES: The public workshop will be Written/Paper Submissions
Carla Smith, Executive Vice President, held on November 28, 2017, from 8:30 Submit written/paper submissions as
Healthcare Information and a.m. to 5 p.m. Submit either electronic follows:
Management Systems Society (HIMSS); or written comments on this public • Mail/Hand delivery/Courier (for
Tobin Van Ostern, Vice President and workshop by November 27, 2017. See written/paper submissions): Dockets
Co-Founder, Young Invincibles the SUPPLEMENTARY INFORMATION section Management Staff (HFA–305), Food and
Advisors; and Paula Villescaz, Senior for registration date and information. Drug Administration, 5630 Fishers
Consultant, Assembly Health ADDRESSES: The public workshop will Lane, Rm. 1061, Rockville, MD 20852.
Committee, California State Legislature. be held at FDA’s White Oak Campus, • For written/paper comments
III. Copies of the Charter 10903 New Hampshire Ave., Bldg. 31, submitted to the Dockets Management
Rm. 1503 (The Great Room), Silver Staff, FDA will post your comment, as
The Secretary’s Charter for the APOE Spring, MD 20993. Entrance for the well as any attachments, except for
is available on the CMS Web site at: public workshop participants (non-FDA information submitted, marked and
https://www.cms.gov/Regulations-and- employees) is through Building 1 where identified, as confidential, if submitted
Guidance/Guidance/FACA/Downloads/ routine security check procedures will as detailed in ‘‘Instructions.’’
APOECharter2017.pdf or you may be performed. For parking and security Instructions: All submissions received
obtain a copy of the charter by must include the Docket No. FDA–
sradovich on DSKBCFCHB2PROD with NOTICES
information, please refer to http://
submitting a request to: Thomas Dudley, www.fda.gov/AboutFDA/ 2017–N–4179 for ‘‘Cardiac Troponin
Designated Federal Official (DFO), WorkingatFDA/BuildingsandFacilities/ Assays.’’ Received comments, those
Office of Communications, Centers for WhiteOakCampusInformation/ filed in a timely manner (see
Medicare & Medicaid Services, 7500 ucm241740.htm. ADDRESSES) will be placed in the docket
Security Boulevard, Mailstop S1 05–06, You may submit comments as and, except for those submitted as
Baltimore, MD 21244 1850 or via email follows. Please note that late, untimely ‘‘Confidential Submissions,’’ publicly
at Thomas.Dudley@cms.hhs.gov. filed comments will not be considered. viewable at https://www.regulations.gov
VerDate Sep<11>2014 17:38 Jul 28, 2017 Jkt 241001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\FR\FM\31JYN1.SGM 31JYN1](https://thefederalregister.org/doc/82_FR_35677/page/1.svg)
![35534 Federal Register / Vol. 82, No. 145 / Monday, July 31, 2017 / Notices
November 17, 2017 by 4 p.m. If selected Dated: July 20, 2017. Hampshire Ave., Bldg. 51, Rm. 6314,
for presentation, any presentation Anna K. Abram, Silver Spring, MD 20993, (301) 796–
materials must be emailed to Paula Deputy Commissioner for Policy, Planning, 7578, Kayla.Garvin@fda.hhs.gov.
Caposino (see FOR FURTHER INFORMATION Legislation, and Analysis. SUPPLEMENTARY INFORMATION:
CONTACT) no later than November 21, [FR Doc. 2017–16007 Filed 7–28–17; 8:45 am]
I. Background
2017. No commercial or promotional BILLING CODE 4164–01–P
material will be permitted to be RWD (data relating to patient health
presented or distributed at the public status and/or the delivery of health care
workshop. DEPARTMENT OF HEALTH AND routinely collected from a variety of
HUMAN SERVICES sources) and RWE (clinical evidence
Streaming Webcast of the public regarding the usage and potential
workshop: This public workshop will Food and Drug Administration benefits or risks of a drug derived from
also be Webcast. The Webcast link will analysis of RWD) are increasingly being
[Docket No. FDA–2017–N–0001]
be available on the registration Web used by multiple stakeholders within
page after November 21, 2017. Developing a Framework for the health care system. Payers may rely
Organizations are requested to register Regulatory Use of Real-World on RWD and RWE to refine formularies
all participants, but to view using one Evidence; Public Workshop or assist in coverage decisions.
connection per location. Physicians and professional societies
AGENCY: Food and Drug Administration, can utilize RWE to further tailor clinical
If you have never attended a Connect HHS. practice guidelines and decision-
Pro event before, test your connection at
ACTION: Notice of public workshop. support tools. Medical product
https://collaboration.fda.gov/common/ developers can use RWE to further
help/en/support/meeting_test.htm. To SUMMARY: The Food and Drug develop a product’s benefit-risk profile,
get a quick overview of the Connect Pro Administration (FDA, the Agency, or monitor postmarket safety and adverse
program, visit http://www.adobe.com/ we) is announcing the following public events, or generate additional
go/connectpro_overview. FDA has workshop entitled ‘‘Developing a hypotheses for continued clinical
verified the Web site addresses in this Framework for Regulatory Use of Real- development.
document, as of the date this document World Evidence.’’ Convened by the The 21st Century Cures Act, section
publishes in the Federal Register, but Duke-Robert J. Margolis, MD, Center for 3022 (Pub. L. 114–255), enacted on
Web sites are subject to change over Health Policy at Duke University and December 13, 2016, directed FDA to
time. supported by a cooperative agreement establish a program to evaluate the
Transcripts: Please be advised that as with FDA, the purpose of the public potential use of RWE. The framework of
workshop is to bring the stakeholder the program was to include information
soon as a transcript of the public
community together to discuss a variety describing the sources of RWE, the gaps
workshop is available, it will be
of topics related to the use of real-world in data collection, standards and
accessible at https:// methods for collection and analysis, and
data (RWD) and real-world evidence
www.regulations.gov. It may be viewed (RWE) in drug development and the priority areas and challenges.
at the Dockets Management Staff (see regulatory decision making. Topics will To date, RWD and RWE have been
ADDRESSES). A link to the transcript will include an update on FDA’s activities to used in very specific regulatory
also be available approximately 45 days address the use of RWE in regulatory contexts. Some treatments for rare
after the public workshop on the decisions and the development of a diseases, for example, have utilized
Internet at http://www.fda.gov/ framework for tackling challenges RWE as part of the historical controls
MedicalDevices/NewsEvents/ related to RWE’s regulatory used for clinical study and, ultimately,
WorkshopsConferences/default.htm. acceptability. In addition, panelists will regulatory submission. Postmarket
(Select this public workshop from the discuss opportunities to improve data safety surveillance has also relied
posted events list). development activities, study designs, heavily on RWD-generating networks.
and analytical methods used to create As part of exploring the opportunities
IV. References for enhanced use of these types of data
robust RWE.
The following references are on DATES: The public workshop will be and evidence in additional regulatory
display in the Dockets Management held on September 13, 2017, from 9 a.m. decision-making contexts, FDA is
Staff (see ADDRESSES) and are available to 4:30 p.m., Eastern Time. seeking input on the opportunities and
challenges in using RWE to support the
for viewing by interested persons ADDRESSES: The public workshop will
approval of a new indication for an
between 9 a.m. and 4 p.m., Monday be held at the Conference Center at 1777
already approved drug, and to help
through Friday; they are also available F Street NW., Washington, DC 20006.
support or satisfy postapproval study
electronically at https:// For additional travel and hotel
requirements.
www.regulations.gov. information, please refer to the This public workshop is being held to
following Web site: https:// engage external stakeholders in
1. ‘‘National Academy of Clinical
healthpolicy.duke.edu/events/public- discussions around the current state of
Biochemistry Laboratory Medicine
Practice Guidelines: Clinical
workshop-developing-framework- RWE development and potential
Characteristics and Utilization of
regulatory-use-real-world-evidence. challenge areas for using RWE in
There will also be a live webcast for
sradovich on DSKBCFCHB2PROD with NOTICES
Biochemical Markers in Acute Coronary regulatory decisions beyond postmarket
Syndromes.’’ Circulation, 2007; 115, those unable to attend the meeting in safety surveillance.
356–375. person (see Streaming Webcast of Public
Workshop). II. Topics for Discussion at the Public
2. ‘‘Universal Definition of Myocardial
Infarction.’’ Circulation, 2007: 116, FOR FURTHER INFORMATION CONTACT: Workshop
2634–2653. Kayla Garvin, Center for Drug During the course of the public
Evaluation and Research, Food and workshop, speakers and participants
Drug Administration, 10903 New will cover a range of issues related to
VerDate Sep<11>2014 17:38 Jul 28, 2017 Jkt 241001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\31JYN1.SGM 31JYN1](https://thefederalregister.org/doc/82_FR_35677/page/3.svg)
Document Created: 2017-07-29 00:21:17
Document Modified: 2017-07-29 00:21:17
| 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 November 28, 2017, from 8:30 a.m. to 5 p.m. Submit either electronic or written comments on this public workshop by November 27, 2017. See the SUPPLEMENTARY INFORMATION section for registration date and information. | |
| Contact | Paula Caposino, Food and Drug Administration, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 4644, Silver Spring, MD 20993, 301-796- 6160, [email protected] | |
| FR Citation | 82 FR 35532 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR