81 FR 90361 - Public Meeting on Patient-Focused Drug Development for Sarcopenia; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 240 (December 14, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 240 (December 14, 2016)
| Page Range | 90361-90363 | |
| FR Document | 2016-29998 |
[Federal Register Volume 81, Number 240 (Wednesday, December 14, 2016)] [Notices] [Pages 90361-90363] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-29998] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-N-2016-4198] Public Meeting on Patient-Focused Drug Development for Sarcopenia; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing a public meeting and an opportunity for public comment on ``Patient- Focused Drug Development for Sarcopenia.'' Patient-Focused Drug Development is part of FDA's performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patient perspectives on the impact of sarcopenia on daily life as well as patient views on treatment approaches for sarcopenia. DATES: The public meeting will be held on April 6, 2017, from 1 p.m. to 5 p.m. Registration to attend the meeting must be received by March 27, 2017 (see SUPPLEMENTARY INFORMATION for instructions). Public comments will be accepted through June 6, 2017. See the ADDRESSES section for information about submitting comments to the public docket. ADDRESSES: The public meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room, (Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For more information on parking and security procedures, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: 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): 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-4198 for ``Public Meeting on Patient-Focused Drug Development for Sarcopenia; Request for Comments.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://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 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 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 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FDA will post the agenda approximately 5 days before the meeting [[Page 90362]] at: http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm527587.htm. FOR FURTHER INFORMATION CONTACT: Meghana Chalasani, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 240- 402-6525, FAX: 301-847-8443, [email protected]. SUPPLEMENTARY INFORMATION: I. Background on Patient-Focused Drug Development FDA has selected sarcopenia as the focus of a public meeting under Patient-Focused Drug Development, an initiative that involves obtaining a better understanding of patient perspectives on the severity of a disease and the available therapies for that condition. Patient-Focused Drug Development is being conducted to fulfill FDA performance commitments that are part of the reauthorization of the PDUFA under Title I of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144). The full set of performance commitments is available at http://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm270412.pdf. FDA committed to obtain the patient perspective on at least 20 disease areas during the course of PDUFA V. For each disease area, the Agency is conducting a public meeting to discuss the disease and its impact on patients' daily lives, the types of treatment benefit that matter most to patients, and patients' perspectives on the adequacy of the available therapies. These meetings will include participation of FDA review divisions, the relevant patient communities, and other interested stakeholders. On April 11, 2013, FDA published a notice in the Federal Register (78 FR 21613) announcing the disease areas for meetings in fiscal years (FYs) 2013-2015, the first 3 years of the 5-year PDUFA V time frame. The Agency used several criteria outlined in that notice to develop the list of disease areas. FDA obtained public comment on the Agency's proposed criteria and potential disease areas through a public docket and a public meeting that was convened on October 25, 2012. In selecting the set of disease areas, FDA carefully considered the public comments received and the perspectives of review divisions at FDA. FDA initiated a second public process for determining the disease areas for FY 2016-2017, and published a notice in the Federal Register on July 2, 2015 (80 FR 38216), announcing the selection of eight disease areas. More information, including the list of disease areas and a general schedule of meetings, is posted at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm326192.htm. II. Public Meeting Information As part of Patient-Focused Drug Development, FDA will obtain patient and patient stakeholder input on the symptoms of sarcopenia that matter most to patients and on current approaches to treating sarcopenia. Sarcopenia is a condition characterized by loss of muscle mass and loss of muscle function or strength that occurs with age. While there is currently no cure, treatments for sarcopenia are primarily non-drug therapies including exercise and nutrition. FDA is interested in the perspectives of patients with sarcopenia on (1) symptoms and the daily impacts of their condition, (2) current approaches to treatment, and (3) decision factors taken into account when selecting a treatment. The questions that will be asked of patients and patient stakeholders at the meeting are listed in this section, organized by topic. For each topic, a brief initial patient panel discussion will begin the dialogue. This will be followed by a facilitated discussion inviting comments from other patient and patient stakeholder participants. In addition to input generated through this public meeting, FDA is interested in receiving patient input addressing these questions through written comments, which can be submitted to the public docket (see ADDRESSES). Topic 1: Disease Symptoms and Daily Impacts That Matter Most to Patients (1) Of all the symptoms that you experience because of your condition, which one to three symptoms have the most significant impact on your life? (Examples may include difficulty walking, feeling unsteady and falling frequently, having a decreased level of activity, etc.) (2) Are there specific activities that are important to you but that you cannot do at all or as fully as you would like because of your condition? (Examples of activities may include participation in social activities, household chores, daily hygiene, etc.) (3) How do your symptoms and their negative impacts affect your daily life on the best days? On the worst days? (4) How have your condition and its symptoms changed over time? (a) Would you define your condition today as being well managed? (5) What worries you most about your condition? Topic 2: Patients' Perspectives on Current Approaches to Treatment (1) What are you currently doing to help treat your condition or its symptoms? (Examples may include prescription medicines, over-the- counter products, and other therapies including non-drug therapies such as diet modification.) (a) What specific symptoms do your treatments address? (b) How has your treatment regimen changed over time, and why? (2) How well does your current treatment regimen control your condition? (a) How well do your treatments address specific activities that are important to you in your daily life? (b) How well have these treatments worked for you as your condition has changed over time? (3) What are the most significant downsides to your current treatments, and how do they affect your daily life? (Examples of downsides may include going to the hospital or clinic for treatment, time devoted to treatment, etc.) (4) What specific things would you look for in an ideal treatment for your condition? (a) What would you consider to be a meaningful improvement (for example, symptom improvements or functional improvements) in your condition that a treatment could provide? III. Meeting Attendance and Participation If you wish to attend this meeting, visit https://sarcopeniapfdd.eventbrite.com. Please register by March 27, 2017. If you are unable to attend the meeting in person, you can register to view a live Webcast of the meeting. You will be asked to indicate in your registration if you plan to attend in person or via the Webcast. Seating will be limited, so early registration is recommended. Registration is free and will be on a first-come, first-served basis. However, FDA may limit the number of participants from each organization based on space limitations. Registrants will receive confirmation once they have been accepted. Onsite registration on the day of the meeting will be based on space availability. If you need special accommodations because of a disability, please contact Meghana Chalasani (see FOR FURTHER INFORMATION CONTACT) at least 7 days before the meeting. [[Page 90363]] Patients who are interested in presenting comments as part of the initial panel discussions will be asked to indicate in their registration which topic(s) they wish to address. These patients also must send to [email protected] a brief summary of responses to the topic questions by March 20, 2017. Panelists will be notified of their selection approximately 7 days before the public meeting. We will try to accommodate all patients and patient stakeholders who wish to speak, either through the panel discussion or audience participation; however, the duration of comments may be limited by time constraints. Transcripts: Please be advised that as soon as a transcript of the public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Division of Dockets Management (see ADDRESSES). A link to the transcript will also be available on the Internet at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm527587.htm. Dated: December 9, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-29998 Filed 12-13-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 240 / Wednesday, December 14, 2016 / Notices 90361
Review Improvement Act of 1982 be received by March 27, 2017 (see comment, as well as any attachments,
amended Title XI of the Social Security SUPPLEMENTARY INFORMATION for except for information submitted,
Act to create the Utilization and Quality instructions). Public comments will be marked and identified, as confidential,
Control Peer Review Organization (PRO) accepted through June 6, 2017. See the if submitted as detailed in
program which replaces the Professional ADDRESSES section for information about ‘‘Instructions.’’
Standards Review Organization (PSRO) submitting comments to the public Instructions: All submissions received
program and streamlines peer review docket. must include the Docket No. FDA–
activities. The term PRO has been ADDRESSES: The public meeting will be 2016–N–4198 for ‘‘Public Meeting on
renamed Quality Improvement held at the FDA White Oak Campus, Patient-Focused Drug Development for
Organization (QIO). This information 10903 New Hampshire Ave., Bldg. 31 Sarcopenia; Request for Comments.’’
collection describes the review Conference Center, the Great Room, Received comments will be placed in
functions to be performed by the QIO. (Rm. 1503), Silver Spring, MD 20993– the docket and, except for those
It outlines relationships among QIOs, 0002. Entrance for the public meeting submitted as ‘‘Confidential
providers, practitioners, beneficiaries, participants (non-FDA employees) is Submissions,’’ publicly viewable at
intermediaries, and carriers. Form through Building 1 where routine https://www.regulations.gov or at the
Number: CMS–R–71 (OMB Control security check procedures will be Division of Dockets Management
Number: 0938–0445); Frequency: performed. For more information on between 9 a.m. and 4 p.m., Monday
Yearly; Affected Public: Private sector— parking and security procedures, please through Friday.
Business or other for-profit and Not-for- refer to http://www.fda.gov/AboutFDA/ • Confidential Submissions—To
profit institutions; Number of WorkingatFDA/BuildingsandFacilities/ submit a comment with confidential
Respondents: 6,939; Total Annual WhiteOakCampusInformation/ information that you do not wish to be
Responses: 44,015; Total Annual Hours: ucm241740.htm. made publicly available, submit your
100,065. (For policy questions regarding You may submit comments as comments only as a written/paper
this collection contact Tennille Coombs follows: submission. You should submit two
at 410–786–3472.) copies total. One copy will include the
Dated: December 9, 2016.
Electronic Submissions information you claim to be confidential
William N. Parham, III, Submit electronic comments in the with a heading or cover note that states
Director, Paperwork Reduction Staff, Office following way: ‘‘THIS DOCUMENT CONTAINS
of Strategic Operations and Regulatory • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
Affairs. https://www.regulations.gov. Follow the Agency will review this copy, including
[FR Doc. 2016–30024 Filed 12–13–16; 8:45 am] instructions for submitting comments. the claimed confidential information, in
BILLING CODE 4120–01–P Comments submitted electronically, its consideration of comments. The
including attachments, to https:// second copy, which will have the
www.regulations.gov will be posted to claimed confidential information
DEPARTMENT OF HEALTH AND the docket unchanged. Because your redacted/blacked out, will be available
HUMAN SERVICES comment will be made public, you are for public viewing and posted on
solely responsible for ensuring that your https://www.regulations.gov. Submit
Food and Drug Administration comment does not include any both copies to the Division of Dockets
confidential information that you or a Management. If you do not wish your
[Docket No. FDA–N–2016–4198]
third party may not wish to be posted, name and contact information to be
Public Meeting on Patient-Focused such as medical information, your or made publicly available, you can
Drug Development for Sarcopenia; anyone else’s Social Security number, or provide this information on the cover
Request for Comments confidential business information, such sheet and not in the body of your
as a manufacturing process. Please note comments and you must identify this
AGENCY: Food and Drug Administration, that if you include your name, contact information as ‘‘confidential.’’ Any
HHS. information, or other information that information marked as ‘‘confidential’’
ACTION: Notice of public meeting; identifies you in the body of your will not be disclosed except in
request for comments. comments, that information will be accordance with 21 CFR 10.20 and other
posted on https://www.regulations.gov. applicable disclosure law. For more
SUMMARY: The Food and Drug • If you want to submit a comment information about FDA’s posting of
Administration (FDA or Agency) is with confidential information that you comments to public dockets, see 80 FR
announcing a public meeting and an do not wish to be made available to the 56469, September 18, 2015, or access
opportunity for public comment on public, submit the comment as a the information at: http://www.fda.gov/
‘‘Patient-Focused Drug Development for written/paper submission and in the regulatoryinformation/dockets/
Sarcopenia.’’ Patient-Focused Drug manner detailed (see ‘‘Written/Paper default.htm.
Development is part of FDA’s Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to
performance commitments made as part read background documents or the
of the fifth authorization of the Written/Paper Submissions electronic and written/paper comments
Prescription Drug User Fee Act (PDUFA Submit written/paper submissions as received, go to https://
V). The public meeting is intended to follows: www.regulations.gov and insert the
allow FDA to obtain patient • Mail/Hand delivery/Courier (for docket number, found in brackets in the
sradovich on DSK3GMQ082PROD with NOTICES
perspectives on the impact of written/paper submissions): Division of heading of this document, into the
sarcopenia on daily life as well as Dockets Management (HFA–305), Food ‘‘Search’’ box and follow the prompts
patient views on treatment approaches and Drug Administration, 5630 Fishers and/or go to the Division of Dockets
for sarcopenia. Lane, Rm. 1061, Rockville, MD 20852. Management, 5630 Fishers Lane, Rm.
DATES: The public meeting will be held • For written/paper comments 1061, Rockville, MD 20852.
on April 6, 2017, from 1 p.m. to 5 p.m. submitted to the Division of Dockets FDA will post the agenda
Registration to attend the meeting must Management, FDA will post your approximately 5 days before the meeting
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![Federal Register / Vol. 81, No. 240 / Wednesday, December 14, 2016 / Notices 90363
Patients who are interested in Dated: December 9, 2016. been approved by the Office of
presenting comments as part of the Leslie Kux, Management and Budget (OMB) under
initial panel discussions will be asked Associate Commissioner for Policy. the Paperwork Reduction Act of 1995.
to indicate in their registration which [FR Doc. 2016–29998 Filed 12–13–16; 8:45 am]
topic(s) they wish to address. These FOR FURTHER INFORMATION CONTACT: FDA
BILLING CODE 4164–01–P
patients also must send to PRA Staff, Office of Operations, Food
PatientFocused@fda.hhs.gov a brief and Drug Administration, Three White
summary of responses to the topic DEPARTMENT OF HEALTH AND Flint North, 10A63, 11601 Landsdown
questions by March 20, 2017. Panelists HUMAN SERVICES St., North Bethesda, MD 20852,
will be notified of their selection PRAStaff@fda.hhs.gov.
approximately 7 days before the public Food and Drug Administration SUPPLEMENTARY INFORMATION: The
meeting. We will try to accommodate all [Docket Nos. FDA–2013–N–0375; FDA– following is a list of FDA information
patients and patient stakeholders who 2013–N–0370; FDA–2013–N–0134; FDA– collections recently approved by OMB
wish to speak, either through the panel 2009–N–0511; FDA–1997–N–0020; FDA– under section 3507 of the Paperwork
discussion or audience participation; 2011–N–0902; FDA–2013–N–0662; FDA–
Reduction Act of 1995 (44 U.S.C. 3507).
however, the duration of comments may 2013–N–0450; FDA–2012–N–0477; FDA–
be limited by time constraints. 2013–N–0519] The OMB control number and
Transcripts: Please be advised that as expiration date of OMB approval for
soon as a transcript of the public Agency Information Collection each information collection are shown
meeting is available, it will be accessible Activities; Announcement of Office of in table 1. Copies of the supporting
at https://www.regulations.gov. It may Management and Budget Approvals statements for the information
be viewed at the Division of Dockets AGENCY: Food and Drug Administration, collections are available on the Internet
Management (see ADDRESSES). A link to HHS. at http://www.reginfo.gov/public/do/
the transcript will also be available on PRAMain. An Agency may not conduct
ACTION: Notice.
the Internet at http://www.fda.gov/ or sponsor, and a person is not required
ForIndustry/UserFees/ SUMMARY: The Food and Drug to respond to, a collection of
PrescriptionDrugUserFee/ Administration (FDA) is publishing a information unless it displays a
ucm527587.htm. list of information collections that have currently valid OMB control number.
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
Date
OMB
Title of collection approval
control No. expires
Agreement for Shipments of Devices for Sterilization ............................................................................................ 0910–0131 9/30/2019
Export of Medical Devices—Foreign Letters of Approval ....................................................................................... 0910–0264 9/30/2019
Mammography Facilities, Standards, and Lay Summaries for Patients ................................................................. 0910–0309 9/30/2019
Medicated Fee Mill License Application .................................................................................................................. 0910–0337 9/30/2019
Substances Generally Recognized as Safe: Notification Procedure ...................................................................... 0910–0342 9/30/2019
Prescription Drug Product Labeling; Medication Guide Requirements ................................................................... 0910–0393 9/30/2019
Applications for FDA Approval to Market a New Drug: Patent Submission and Listing Requirements and Appli-
cation of 30-month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claim-
ing a Drug is Invalid or Will Not be Infringed ...................................................................................................... 0910–0513 9/30/2016
Substances Prohibited from Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed .......... 0910–0339 10/31/2019
Investigational Device Exemptions Reports and Records—21 CFR 812 ............................................................... 0910–0078 11/30/2019
Guidance for Industry on How to Submit Information in Electronic Format to the Center for Veterinary Medicine
Using the FDA Electronic Submission Gateway ................................................................................................. 0910–0454 11/30/2019
Dated: December 9, 2016. SUMMARY: The Food and Drug I. Background
Leslie Kux, Administration (FDA) is announcing the
fiscal year (FY) 2017 fee rate for Section 307 of FSMA, Accreditation
Associate Commissioner for Policy.
accreditation bodies applying to be of Third-Party Auditors, amends the
[FR Doc. 2016–30035 Filed 12–13–16; 8:45 am]
recognized in the third-party FD&C Act to create a new provision,
BILLING CODE 4164–01–P
certification program that is authorized section 808, under the same name.
by the Federal Food, Drug, and Section 808 of the FD&C Act (21 U.S.C.
Cosmetic Act (the FD&C Act), as 384d) directs us to establish a new
DEPARTMENT OF HEALTH AND
amended by the FDA Food Safety program for accreditation of third-party
HUMAN SERVICES
Modernization Act (FSMA). certification bodies 1 conducting food
Food and Drug Administration safety audits and issuing food and
FOR FURTHER INFORMATION CONTACT:
facility certifications to eligible foreign
[Docket No. FDA–2016–N–4119] Sylvia Kim, Office of Foods and
entities (including registered foreign
Veterinary Medicine, Food and Drug
sradovich on DSK3GMQ082PROD with NOTICES
Food Safety Modernization Act Third- Administration, 10903 New Hampshire 1 For the reasons explained in the third-party
Party Certification Program User Fee Ave., Bldg. 1, Rm. 3212, Silver Spring, certification final rule (80 FR74570 at 74578–74579,
Rate for Fiscal Year 2017 MD 20993, 301–796–7599. November 27, 2015), and for consistency with the
DATES: This fee is effective January 13, implementing regulations for the third-party
AGENCY: Food and Drug Administration, certification program in 21 CFR parts 1, 11, and 16,
2017, and will remain in effect through
HHS. this notice uses the term ‘‘third-party certification
September 30, 2017. body’’ rather than the term ‘‘third-party auditor’’
ACTION: Notice.
SUPPLEMENTARY INFORMATION: used in section 808(a)(3) of the FD&C Act.
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Document Created: 2016-12-14 00:48:43
Document Modified: 2016-12-14 00:48:43
| 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 meeting; request for comments. | |
| Dates | The public meeting will be held on April 6, 2017, from 1 p.m. to 5 p.m. Registration to attend the meeting must be received by March 27, 2017 (see SUPPLEMENTARY INFORMATION for instructions). Public comments | |
| Contact | Meghana Chalasani, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 240- 402-6525, FAX: 301-847-8443, [email protected] | |
| FR Citation | 81 FR 90361 |
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