81 FR 39054 - Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 042
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 115 (June 15, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 115 (June 15, 2016)
| Page Range | 39054-39056 | |
| FR Document | 2016-13990 |
[Federal Register Volume 81, Number 115 (Wednesday, June 15, 2016)] [Notices] [Pages 39054-39056] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-13990] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2004-N-0451] Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 042 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 042'' (Recognition List Number: 042), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. DATES: Submit electronic or written comments concerning this document at any time. These modifications to the list of recognized standards are effective June 15, 2016. ADDRESSES: 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-2004-N-0451 for ``Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 042.'' 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. FDA will consider any comments received in determining whether to amend the current listing of modifications to the list of recognized standards, Recognition List Number: 042. 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 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. An electronic copy of Recognition List Number: 042 is available on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See section VI of this document for electronic access to the searchable database for the current list of FDA recognized consensus standards, including Recognition List Number: 042 modifications and other standards related information. Submit written requests for a single hard copy of the document entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 042'' to the Division of Industry and Consumer Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301-847- 8149. [[Page 39055]] FOR FURTHER INFORMATION CONTACT: Scott A. Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993, 301-796- 6287, [email protected]. SUPPLEMENTARY INFORMATION: I. Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d). Amended section 514 allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions or other requirements. In a notice published in the Federal Register of February 25, 1998 (63 FR 9561), FDA announced the availability of a guidance entitled ``Recognition and Use of Consensus Standards.'' The notice described how FDA would implement its standards recognition program and provided the initial list of recognized standards. Modifications to the initial list of recognized standards, as published in the Federal Register, can be accessed at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. These notices describe the addition, withdrawal, and revision of certain standards recognized by FDA. The Agency maintains hypertext markup language (HTML) and portable document format (PDF) versions of the list of FDA Recognized Consensus Standards. Both versions are publicly accessible at the Agency's Internet site. See section VI of this document for electronic access information. Interested persons should review the supplementary information sheet for the standard to understand fully the extent to which FDA recognizes the standard. II. Modifications to the List of Recognized Standards, Recognition List Number: 042 FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the Agency will recognize for use in premarket submissions and other requirements for devices. FDA will incorporate these modifications in the list of FDA Recognized Consensus Standards in the Agency's searchable database. FDA will use the term ``Recognition List Number: 042'' to identify these current modifications. In table 1, FDA describes the following modifications: (1) The withdrawal of standards and their replacement by others, if applicable; (2) the correction of errors made by FDA in listing previously recognized standards; and (3) the changes to the supplementary information sheets of recognized standards that describe revisions to the applicability of the standards. In section III, FDA lists modifications the Agency is making that involve the initial addition of standards not previously recognized by FDA. Table 1--Modifications to the List of Recognized Standards ---------------------------------------------------------------------------------------------------------------- Replacement Old recognition No. recognition Title of standard \1\ Change No. ---------------------------------------------------------------------------------------------------------------- A. Cardiovascular ---------------------------------------------------------------------------------------------------------------- 3-131............................ .............. ANSI/AAMI/ISO 27185:2012, Extent of recognition and cardiac rhythm management Relevant guidance. devices--Symbols to be used with cardiac rhythm management device labels, and information to be supplied--general requirements. 3-132............................ .............. ISO 27185 First edition 2012-02- Extent of recognition and 15, cardiac rhythm management Relevant guidance. devices--Symbols to be used with cardiac rhythm management device labels, and information to be supplied--general requirements. ---------------------------------------------------------------------------------------------------------------- B. General I (QS/RM) ---------------------------------------------------------------------------------------------------------------- 5-90............................. .............. ISO 15223-1 Second Edition 2012- Extent of recognition, 07-01, medical devices--symbols Relevant guidance. to be used with medical device labels, labelling, and information to be supplied-- Part 1: General requirements. 5-91............................. .............. ANSI/AAMI/ISO 15223-1:2012, Extent of recognition and Medical devices--Symbols to be Relevant guidance. used with medical devices labels, labeling, and information to be supplied-- Part 1: General requirements. ---------------------------------------------------------------------------------------------------------------- C. Material ---------------------------------------------------------------------------------------------------------------- 8-349............................ .............. ASTM F2503-13 Standard Practice Relevant guidance. For Marking Medical Devices And Other Items For Safety In The Magnetic Resonance Environment. ---------------------------------------------------------------------------------------------------------------- \1\ All standard titles in this table conform to the style requirements of the respective organizations. III. Listing of New Entries In table 2, FDA provides the listing of new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 042. [[Page 39056]] Table 2--New Entries to the List of Recognized Standards ------------------------------------------------------------------------ Reference No. Recognition No. Title of standard \1\ and date ------------------------------------------------------------------------ A. General I ------------------------------------------------------------------------ 5-102................ Graphical symbols for use on IEC 60417:2002 equipment. DB. 5-103................ Graphical symbols for use on ISO 7000: Fifth equipment--Registered symbols. edition 2014-01- 15. 5-104................ Graphical symbols for IEC/TR 60878 Ed. electrical equipment in 3.0 b:2015. medical practice. ------------------------------------------------------------------------ \1\ All standard titles in this table conform to the style requirements of the respective organizations. IV. List of Recognized Standards FDA maintains the Agency's current list of FDA Recognized Consensus Standards in a searchable database that may be accessed directly at FDA's Internet site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. FDA will incorporate the modifications and revisions described in this notice into the database and, upon publication in the Federal Register, this recognition of consensus standards will be effective. FDA will announce additional modifications and revisions to the list of recognized consensus standards, as needed, in the Federal Register, once a year or more often if necessary. Beginning with Recognition List: 033, FDA no longer announces minor revisions to the list of recognized consensus standards such as technical contact person, devices affected, processes affected, Code of Federal Regulations citations, and product codes. V. Recommendation of Standards for Recognition by FDA Any person may recommend consensus standards as candidates for recognition under section 514 of the FD&C Act by submitting such recommendations, with reasons for the recommendation, to [email protected]. To be properly considered, such recommendations should contain, at a minimum, the following information: (1) Title of the standard, (2) any reference number and date, (3) name and address of the national or international standards development organization, (4) a proposed list of devices for which a declaration of conformity to this standard should routinely apply, and (5) a brief identification of the testing or performance or other characteristics of the device(s) that would be addressed by a declaration of conformity. VI. Electronic Access You may obtain a copy of ``Guidance on the Recognition and Use of Consensus Standards'' by using the Internet. The Center for Devices and Radiological Health (CDRH) maintains a site on the Internet for easy access to information including text, graphics, and files that you may download to a personal computer with access to the Internet. Updated on a regular basis, the CDRH home page, http://www.fda.gov/MedicalDevices, includes a link to standards-related documents including the guidance and the current list of recognized standards. After publication in the Federal Register, this notice announcing ``Modification to the List of Recognized Standards, Recognition List Number: 042'' will be available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. You may access ``Guidance on the Recognition and Use of Consensus Standards,'' and the searchable database for ``FDA Recognized Consensus Standards,'' at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards. Dated: June 8, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-13990 Filed 6-14-16; 8:45 am] BILLING CODE 4164-01-P
![39054 Federal Register / Vol. 81, No. 115 / Wednesday, June 15, 2016 / Notices
• The physical address(es) of the • Federal eRulemaking Portal: http:// submission. You should submit two
site(s) for which you are submitting a www.regulations.gov. Follow the copies total. One copy will include the
request; instructions for submitting comments. information you claim to be confidential
• The type of processes (e.g., Comments submitted electronically, with a heading or cover note that states
manufacturing, laboratory practices, including attachments, to http:// ‘‘THIS DOCUMENT CONTAINS
mixing, packaging, labeling, and www.regulations.gov will be posted to CONFIDENTIAL INFORMATION.’’ The
distribution activities) performed at the docket unchanged. Because your Agency will review this copy, including
your facility; comment will be made public, you are the claimed confidential information, in
• The type of tobacco products tested, solely responsible for ensuring that your its consideration of comments. The
processed, or manufactured at your comment does not include any second copy, which will have the
facility; and confidential information that you or a claimed confidential information
• A proposed program agenda. third party may not wish to be posted, redacted/blacked out, will be available
Identify requests for participation such as medical information, your or for public viewing and posted on http://
with the docket number found in anyone else’s Social Security number, or www.regulations.gov. Submit both
brackets in the heading of this confidential business information, such copies to the Division of Dockets
document. Received requests are as a manufacturing process. Please note Management. If you do not wish your
available for public examination in the that if you include your name, contact name and contact information to be
Division of Dockets Management (see information, or other information that made publicly available, you can
ADDRESSES) between 9 a.m. and 4 p.m., identifies you in the body of your provide this information on the cover
Monday through Friday. comments, that information will be sheet and not in the body of your
Dated: June 9, 2016. posted on http://www.regulations.gov. comments and you must identify this
Leslie Kux, • If you want to submit a comment information as ‘‘confidential.’’ Any
Associate Commissioner for Policy. with confidential information that you information marked as ‘‘confidential’’
[FR Doc. 2016–14139 Filed 6–14–16; 8:45 am]
do not wish to be made available to the will not be disclosed except in
BILLING CODE 4164–01–P
public, submit the comment as a accordance with 21 CFR 10.20 and other
written/paper submission and in the applicable disclosure law. For more
manner detailed (see ‘‘Written/Paper information about FDA’s posting of
DEPARTMENT OF HEALTH AND Submissions’’ and ‘‘Instructions’’). comments to public dockets, see 80 FR
HUMAN SERVICES Written/Paper Submissions 56469, September 18, 2015, or access
the information at: http://www.fda.gov/
Food and Drug Administration Submit written/paper submissions as
regulatoryinformation/dockets/
follows:
[Docket No. FDA–2004–N–0451] • Mail/Hand delivery/Courier (for default.htm.
written/paper submissions): Division of Docket: For access to the docket to
Food and Drug Administration read background documents or the
Dockets Management (HFA–305), Food
Modernization Act of 1997: electronic and written/paper comments
and Drug Administration, 5630 Fishers
Modifications to the List of Recognized received, go to http://
Lane, Rm. 1061, Rockville, MD 20852.
Standards, Recognition List Number: • For written/paper comments www.regulations.gov and insert the
042 submitted to the Division of Dockets docket number, found in brackets in the
AGENCY: Food and Drug Administration, Management, FDA will post your heading of this document, into the
HHS. comment, as well as any attachments, ‘‘Search’’ box and follow the prompts
except for information submitted, and/or go to the Division of Dockets
ACTION: Notice.
marked and identified, as confidential, Management, 5630 Fishers Lane, Rm.
SUMMARY: The Food and Drug if submitted as detailed in 1061, Rockville, MD 20852.
Administration (FDA or Agency) is ‘‘Instructions.’’ An electronic copy of Recognition List
announcing a publication containing Instructions: All submissions received Number: 042 is available on the Internet
modifications the Agency is making to must include the Docket No. FDA– at http://www.fda.gov/MedicalDevices/
the list of standards FDA recognizes for 2004–N–0451 for ‘‘Food and Drug DeviceRegulationandGuidance/
use in premarket reviews (FDA Administration Modernization Act of Standards/ucm123792.htm. See section
Recognized Consensus Standards). This 1997: Modifications to the List of VI of this document for electronic access
publication, entitled ‘‘Modifications to Recognized Standards, Recognition List to the searchable database for the
the List of Recognized Standards, Number: 042.’’ Received comments will current list of FDA recognized
Recognition List Number: 042’’ be placed in the docket and, except for consensus standards, including
(Recognition List Number: 042), will those submitted as ‘‘Confidential Recognition List Number: 042
assist manufacturers who elect to Submissions,’’ publicly viewable at modifications and other standards
declare conformity with consensus http://www.regulations.gov or at the related information. Submit written
standards to meet certain requirements Division of Dockets Management requests for a single hard copy of the
for medical devices. between 9 a.m. and 4 p.m., Monday document entitled ‘‘Modifications to the
DATES: Submit electronic or written through Friday. FDA will consider any List of Recognized Standards,
comments concerning this document at comments received in determining Recognition List Number: 042’’ to the
any time. These modifications to the list whether to amend the current listing of Division of Industry and Consumer
of recognized standards are effective modifications to the list of recognized Education, Center for Devices and
ehiers on DSK5VPTVN1PROD with NOTICES
June 15, 2016. standards, Recognition List Number: Radiological Health, Food and Drug
ADDRESSES: You may submit comments 042. Administration, 10903 New Hampshire
as follows: • Confidential Submissions—To Ave., Bldg. 66, Rm. 4613, Silver Spring,
submit a comment with confidential MD 20993–0002. Send one self-
Electronic Submissions information that you do not wish to be addressed adhesive label to assist that
Submit electronic comments in the made publicly available, submit your office in processing your request, or fax
following way: comments only as a written/paper your request to 301–847–8149.
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![39056 Federal Register / Vol. 81, No. 115 / Wednesday, June 15, 2016 / Notices
TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS
Recognition No. Title of standard 1 Reference No. and date
A. General I
5–102 ................. Graphical symbols for use on equipment ................................................................. IEC 60417:2002 DB.
5–103 ................. Graphical symbols for use on equipment—Registered symbols .............................. ISO 7000: Fifth edition 2014–01–15.
5–104 ................. Graphical symbols for electrical equipment in medical practice ............................... IEC/TR 60878 Ed. 3.0 b:2015.
1 All standard titles in this table conform to the style requirements of the respective organizations.
IV. List of Recognized Standards site on the Internet for easy access to DATES: See ‘‘How to Participate in the
FDA maintains the Agency’s current information including text, graphics, Public Meetings’’ in the SUPPLEMENTARY
list of FDA Recognized Consensus and files that you may download to a INFORMATION section of this document
Standards in a searchable database that personal computer with access to the for dates, times, and addresses of the
may be accessed directly at FDA’s Internet. Updated on a regular basis, the public meetings, closing dates for
Internet site at http:// CDRH home page, http://www.fda.gov/ advance registration, requesting special
www.accessdata.fda.gov/scripts/cdrh/ MedicalDevices, includes a link to accommodations due to disability, and
cfdocs/cfStandards/search.cfm. FDA standards-related documents including other information.
will incorporate the modifications and the guidance and the current list of ADDRESSES: See ‘‘How to Participate in
revisions described in this notice into recognized standards. After publication the Public Meetings’’ in the
the database and, upon publication in in the Federal Register, this notice SUPPLEMENTARY INFORMATION section of
the Federal Register, this recognition of announcing ‘‘Modification to the List of this document.
consensus standards will be effective. Recognized Standards, Recognition List FOR FURTHER INFORMATION CONTACT:
FDA will announce additional Number: 042’’ will be available at http:// For questions about registering for
modifications and revisions to the list of www.fda.gov/MedicalDevices/ this meeting or for special
recognized consensus standards, as DeviceRegulationandGuidance/ accommodations due to disability,
needed, in the Federal Register, once a Standards/ucm123792.htm. You may contact Cindy de Sales, The Event
year or more often if necessary. access ‘‘Guidance on the Recognition Planning Group, 8720 Georgia Ave.,
Beginning with Recognition List: 033, and Use of Consensus Standards,’’ and Suite 801, Silver Spring, MD 20910,
FDA no longer announces minor the searchable database for ‘‘FDA 240–316–3207, FAX: 240–652–6002,
revisions to the list of recognized Recognized Consensus Standards,’’ at and email: rsvp@tepgevents.com.
consensus standards such as technical http://www.fda.gov/MedicalDevices/ For general questions about the public
contact person, devices affected, DeviceRegulationandGuidance/ meetings, contact Loretta A. Carey,
processes affected, Code of Federal Standards. Center for Food Safety and Applied
Regulations citations, and product Dated: June 8, 2016.
Nutrition (HFS–820), Food and Drug
codes. Administration, 5100 Paint Branch
Leslie Kux,
Pkwy., College Park, MD 20740, 240–
V. Recommendation of Standards for Associate Commissioner for Policy. 402–2371.
Recognition by FDA [FR Doc. 2016–13990 Filed 6–14–16; 8:45 am]
SUPPLEMENTARY INFORMATION:
Any person may recommend BILLING CODE 4164–01–P
consensus standards as candidates for I. Background
recognition under section 514 of the In the Federal Register of December 1,
FD&C Act by submitting such DEPARTMENT OF HEALTH AND 2014 (79 FR 71156), we published a
recommendations, with reasons for the HUMAN SERVICES final rule on nutrition labeling of
recommendation, to standards@ standard menu items in restaurants and
Food and Drug Administration similar retail food establishments; the
cdrh.fda.gov. To be properly considered,
such recommendations should contain, rule is codified at Title 21 of the Code
[Docket No. FDA–2016–N–0001]
at a minimum, the following of Federal Regulations, section 101.11.
information: (1) Title of the standard, (2) Menu Labeling Public Workshops; The final rule implements section
any reference number and date, (3) Public Meetings 403(q)(5)(H) of the Federal Food, Drug,
name and address of the national or and Cosmetic Act (the FD&C Act) (21
international standards development AGENCY: Food and Drug Administration, U.S.C. 343(q)(5)(H)), which, in general,
organization, (4) a proposed list of HHS. requires that restaurants and similar
devices for which a declaration of ACTION: Notice of public meetings. retail food establishments that are part
conformity to this standard should of a chain with 20 or more locations,
routinely apply, and (5) a brief SUMMARY: The Food and Drug doing business under the same name,
identification of the testing or Administration (FDA or we) is and offering for sale substantially the
performance or other characteristics of announcing two public meetings to same menu items, provide calorie
the device(s) that would be addressed discuss menu labeling requirements. We information for standard menu items
by a declaration of conformity. will announce an additional public (including food on display and self-
ehiers on DSK5VPTVN1PROD with NOTICES
meeting to be held in Oakland, service food), provide, upon request,
VI. Electronic Access California, in a separate Federal additional written nutrition information
You may obtain a copy of ‘‘Guidance Register notice later this year. The for standard menu items, and comply
on the Recognition and Use of purpose of the public meetings is to with other requirements described in
Consensus Standards’’ by using the help the regulated industry comply with section 403(q)(5)(H) of the FD&C Act.
Internet. The Center for Devices and the requirements of the menu labeling On December 18, 2015, the President
Radiological Health (CDRH) maintains a final rule. signed the Consolidated Appropriations
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Document Created: 2016-06-15 02:21:30
Document Modified: 2016-06-15 02:21:30
| 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. | |
| Dates | Submit electronic or written comments concerning this document at any time. These modifications to the list of recognized standards are effective June 15, 2016. | |
| Contact | Scott A. Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993, 301-796- 6287, [email protected] | |
| FR Citation | 81 FR 39054 |
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