81_FR_54972 81 FR 54813 - Pediatric Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

81 FR 54813 - Pediatric Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 159 (August 17, 2016)

Page Range54813-54814
FR Document2016-19589

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee of the Pediatric Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

Federal Register, Volume 81 Issue 159 (Wednesday, August 17, 2016) 
[Federal Register Volume 81, Number 159 (Wednesday, August 17, 2016)]
[Notices]
[Pages 54813-54814]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-19589]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0567]


Pediatric Advisory Committee; Notice of Meeting; Establishment of 
a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice, establishment of a public docket; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee of the Pediatric Advisory Committee. The 
general function of the committee is to provide advice and 
recommendations to the Agency on FDA's regulatory issues. The meeting 
will be open to the public. FDA is establishing a docket for public 
comment on this document.

DATES: The meeting will be held on September 14, 2016, from 8 a.m. to 
5:30 p.m.

ADDRESSES: DoubleTree by Hilton Hotel Bethesda-Washington DC, 8120 
Wisconsin Ave., Bethesda, MD 20814, 301-652-2000. Answers to commonly 
asked questions including information regarding special accommodations 
due to a disability, visitor parking, and transportation may be 
accessed at www.doubletreebethesda.com/. You may submit your 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 
many not wish to be posted, such as medical information, you 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 either the 
Docket No. FDA-2016-N-0567 for the ``Pediatric Advisory Committee; 
Notice of Meeting; Establishment of a Public Docket; Request for 
Comments''; or the Docket No. FDA-2016-N-2470 for the ``Pediatric-
focused Safety Reviews'', which will be posted on the Internet, but not 
presented at the Pediatric Advisory Committee meeting. 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 thatyou 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.

FOR FURTHER INFORMATION CONTACT: Marieann Brill, Office of the 
Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 32, Rm. 5154, Silver Spring, MD 20993, 240-402-3838,

[[Page 54814]]

[email protected] or FDA Advisory Committee Information Line, 
1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in 
the Federal Register about last minute modifications that impact a 
previously announced advisory committee meeting cannot always be 
published quickly enough to provide timely notice. Therefore, you 
should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee meeting link, or call the advisory committee 
information line to learn about possible modifications before coming to 
the meeting. For press inquiries, please contact the Office of Media 
Affairs at [email protected] or 301-796-4540.

SUPPLEMENTARY INFORMATION: Agenda: On September 14, 2016, the Pediatric 
Advisory Committee (PAC) will meet to discuss pediatric-focused safety 
reviews, as mandated by the Best Pharmaceuticals for Children Act (Pub. 
L. 107-109) and the Pediatric Research Equity Act (Pub. L. 108-155). 
Comments about the up-coming September advisory committee meeting 
should be submitted to Docket No. FDA-2016-N-0567.
    The PAC will meet to discuss the following products (listed by FDA 
Center):

1. Center for Biologics Evaluation and Research
    a. MENVEO (Meningococcal (groups A, C, Y and W-135) Oligosaccharide 
Diphtheria CRM197 Conjugate Vaccine)
    b. IXIARO (Japanese encephalitis vaccine)
2. Center for Drug Evaluation and Research
    a. ASACOL & ASACOL HD (mesalamine)
    b. BLOXIVERZ (neostigmine methylsulfate)
    c. DELZICOL (mesalamine)
    d. DORYX (doxycycline hyclate)
    e. KARBINAL ER (carbinoxamine maleate)
    f. KEPIVANCE (palifermin)
    g. SUSTIVA (efavirenz)
    h. TOPAMAX (topiramate)
    i. XOLAIR (omalizumab)
3. Center for Devices and Radiological Health
    a. ELANA SURGICAL KIT (HUD)
    b. BERLIN HEART EXCOR[supreg] Pediatric Ventricular Assist Device 
(VAD)
    c. ENTERRATM THERAPY SYSTEM
    d. CONTEGRA PULMONARY VALVED CONDUIT
    e. PLEXIMMUNE

    FDA will also provide an update of their additional ongoing 
analysis of a possible safety signal regarding the use of the drug 
product Exjade (deferasirox) in children with fever and dehydration 
that was discussed at the September 2015 PAC meeting.
    For the products to be discussed at the PAC meeting, FDA intends to 
make background material available to the public no later than 2 
business days before the meeting. If FDA is unable to post the 
background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material will be 
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before 
September 7, 2016. Oral presentations from the public will be scheduled 
between approximately 8:30 a.m. to 9:30 a.m. Those individuals 
interested in making formal oral presentations should notify the 
contact person and submit a brief statement of the general nature of 
the evidence or arguments they wish to present, the names and addresses 
of proposed participants, and an indication of the approximate time 
requested to make their presentation on or before August 30, 2016. Time 
allotted for each presentation may be limited. If the number of 
registrants requesting to speak is greater than can be reasonably 
accommodated during the scheduled open public hearing session, FDA may 
conduct a lottery to determine the speakers for the scheduled open 
public hearing session. The contact person will notify interested 
persons regarding their request to speak by August 31, 2016.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    FDA is establishing a docket for public comment for the PAC 
meeting. The docket number is FDA-2016-N-0567. The docket will close on 
August 31, 2016. Comments received on or before August 31, 2016, will 
be provided to the committee. Comments received after the date will be 
taken into consideration by the Agency.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
disabilities. If you require accommodations due to a disability, please 
contact Marieann Brill at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).
    Additional Pediatric-focused Safety Reviews: FDA will make 
available additional pediatric safety review reports for selected 
products at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/ucm510701.htm. 
FDA is establishing a second public docket to receive input on 
additional pediatric-focused safety reviews that will be posted on the 
Internet. The docket number is FDA-2016-N-2470; the docket will open on 
September 12, 2016, and remain open until September 23, 2016. These 
safety review reports are for the following products:

1. BARACLUDE (entecavir)
2. ISENTRESS (raltegravir potassium)
3. LYSTEDA (tranexamic acid)
4. SALONPAS Pain Relief Patch (methyl salicylate 10% and l-menthol 3%).

    Dated: August 11, 2016.
Janice M. Soreth,
Acting Associate Commissioner, Special Medical Programs.
[FR Doc. 2016-19589 Filed 8-16-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices 54813 availability of the draft guidance of the public. FDA is establishing a docket for Establishment of a Public Docket; same title dated January 2016. FDA public comment on this document. Request for Comments’’; or the Docket received a few comments on the draft DATES: The meeting will be held on No. FDA–2016–N–2470 for the guidance and those comments were September 14, 2016, from 8 a.m. to 5:30 ‘‘Pediatric-focused Safety Reviews’’, considered as the guidance was p.m. which will be posted on the Internet, finalized. The guidance announced in ADDRESSES: DoubleTree by Hilton Hotel but not presented at the Pediatric this notice finalizes the draft guidance Bethesda-Washington DC, 8120 Advisory Committee meeting. Received of the same title dated January 2016 and Wisconsin Ave., Bethesda, MD 20814, comments will be placed in the docket supplements previous FDA 301–652–2000. Answers to commonly and, except for those submitted as recommendations to HCT/P asked questions including information ‘‘Confidential Submissions,’’ publicly establishments concerning donor testing regarding special accommodations due viewable at http://www.regulations.gov for HBsAg and total antibody to anti- to a disability, visitor parking, and or at the Division of Dockets HBc, in the 2007 Donor Eligibility transportation may be accessed at Management between 9 a.m. and 4 p.m., Guidance. www.doubletreebethesda.com/. You Monday through Friday. This guidance is being issued may submit your comments as follows: • Confidential Submissions—To consistent with FDA’s good guidance submit a comment with confidential practices regulation (21 CFR 10.115). Electronic Submissions information thatyou do not wish to be The guidance represents the current Submit electronic comments in the made publicly available, submit your thinking of FDA on the ‘‘Use of Nucleic following way: comments only as a written/paper Acid Tests to Reduce the Risk of • Federal eRulemaking Portal: http:// submission. You should submit two Transmission of Hepatitis B Virus from www.regulations.gov. Follow the copies total. One copy will include the Donors of Human Cells, Tissues, and instructions for submitting comments. information you claim to be confidential Cellular and Tissue-Based Products.’’ It Comments submitted electronically, with a heading or cover note that states does not establish any rights for any including attachments, to http:// ‘‘THIS DOCUMENT CONTAINS person and is not binding on FDA or the www.regulations.gov will be posted to CONFIDENTIAL INFORMATION’’. The public. You can use an alternative the docket unchanged. Because your Agency will review this copy, including approach if it satisfies the requirements comment will be made public, you are the claimed confidential information, in of the applicable statutes and solely responsible for ensuring that your its consideration of comments. The regulations. comment does not include any second copy, which will have the confidential information that you or a claimed confidential information II. Electronic Access third party many not wish to be posted, redacted/blacked out, will be available Persons with access to the Internet such as medical information, you or for public viewing and posted on http:// may obtain the guidance at either http:// anyone else’s Social Security number, or www.regulations.gov. Submit both www.fda.gov/BiologicsBloodVaccines/ confidential business information, such copies to the Division of Dockets GuidanceComplianceRegulatory as a manufacturing process. Please note Management. If you do not wish your Information/Guidances/default.htm or that if you include your name, contact name and contact information to be http://www.regulations.gov. information, or other information that made publicly available, you can Dated: August 11, 2016. identifies you in the body of your provide this information on the cover Jeremy Sharp, comments, that information will be sheet and not in the body of your Deputy Commissioner for Policy, Planning, posted on http://www.regulations.gov. comments and you must identify this Legislation, and Analysis. • If you want to submit a comment information as ‘‘confidential’’. Any [FR Doc. 2016–19588 Filed 8–16–16; 8:45 am] with confidential information that you information marked as ‘‘confidential’’ 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 DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper information about FDA’s posting of HUMAN SERVICES Submissions’’ and ‘‘Instructions’’). comments to public dockets, see 80 FR 56469, September 18, 2015, or access Food and Drug Administration Written/Paper Submissions the information at: http://www.fda.gov/ Submit written/paper submissions as regulatoryinformation/dockets/ [Docket No. FDA–2016–N–0567] follows: default.htm. • Mail/Hand delivery/Courier (for Docket: For access to the docket to Pediatric Advisory Committee; Notice read background documents or the written/paper submissions): Division of of Meeting; Establishment of a Public electronic and written/paper comments Dockets Management (HFA–305), Food Docket; Request for Comments received, go to http:// and Drug Administration, 5630 Fishers AGENCY: Food and Drug Administration, Lane, Rm. 1061, Rockville, MD 20852. www.regulations.gov and insert the HHS. • For written/paper comments docket number, found in brackets in the submitted to the Division of Dockets heading of this document, into the ACTION: Notice, establishment of a Management, FDA will post your ‘‘Search’’ box and follow the prompts public docket; request for comments. comment, as well as any attachments, and/or go to the Division of Dockets SUMMARY: The Food and Drug except for information submitted, Management, 5630 Fishers Lane, Rm. mstockstill on DSK3G9T082PROD with NOTICES Administration (FDA) announces a marked and identified, as confidential, 1061, Rockville, MD 20852. forthcoming public advisory committee if submitted as detailed in FOR FURTHER INFORMATION CONTACT: of the Pediatric Advisory Committee. ‘‘Instructions’’. Marieann Brill, Office of the The general function of the committee is Instructions: All submissions received Commissioner, Food and Drug to provide advice and recommendations must include either the Docket No. Administration, 10903 New Hampshire to the Agency on FDA’s regulatory FDA–2016–N–0567 for the ‘‘Pediatric Ave., Bldg. 32, Rm. 5154, Silver Spring, issues. The meeting will be open to the Advisory Committee; Notice of Meeting; MD 20993, 240–402–3838, VerDate Sep<11>2014 16:39 Aug 16, 2016 Jkt 238001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\17AUN1.SGM 17AUN1

54814 Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices marieann.brill@fda.hhs.gov or FDA possible safety signal regarding the use disability, please contact Marieann Brill Advisory Committee Information Line, of the drug product Exjade (deferasirox) at least 7 days in advance of the 1–800–741–8138 (301–443–0572 in the in children with fever and dehydration meeting. Washington, DC area). A notice in the that was discussed at the September FDA is committed to the orderly Federal Register about last minute 2015 PAC meeting. conduct of its advisory committee modifications that impact a previously For the products to be discussed at meetings. Please visit our Web site at announced advisory committee meeting the PAC meeting, FDA intends to make http://www.fda.gov/ cannot always be published quickly background material available to the AdvisoryCommittees/ enough to provide timely notice. public no later than 2 business days AboutAdvisoryCommittees/ Therefore, you should always check the before the meeting. If FDA is unable to ucm111462.htm for procedures on Agency’s Web site at http:// post the background material on its Web public conduct during advisory www.fda.gov/AdvisoryCommittees/ site prior to the meeting, the background committee meetings. default.htm and scroll down to the material will be made publicly available Notice of this meeting is given under appropriate advisory committee meeting at the location of the advisory the Federal Advisory Committee Act (5 link, or call the advisory committee committee meeting, and the background U.S.C. app. 2). information line to learn about possible material will be posted on FDA’s Web Additional Pediatric-focused Safety modifications before coming to the site after the meeting. Background Reviews: FDA will make available meeting. For press inquiries, please material will be available at http:// additional pediatric safety review contact the Office of Media Affairs at www.fda.gov/AdvisoryCommittees/ reports for selected products at http:// fdaoma@fda.hhs.gov or 301–796–4540. Calendar/default.htm. Scroll down to www.fda.gov/AdvisoryCommittees/ the appropriate advisory committee CommitteesMeetingMaterials/ SUPPLEMENTARY INFORMATION: Agenda: meeting link. PediatricAdvisoryCommittee/ On September 14, 2016, the Pediatric Procedure: Interested persons may ucm510701.htm. FDA is establishing a Advisory Committee (PAC) will meet to present data, information, or views, discuss pediatric-focused safety second public docket to receive input orally or in writing, on issues pending on additional pediatric-focused safety reviews, as mandated by the Best before the committee. Written Pharmaceuticals for Children Act (Pub. reviews that will be posted on the submissions may be made to the contact Internet. The docket number is FDA– L. 107–109) and the Pediatric Research person on or before September 7, 2016. Equity Act (Pub. L. 108–155). Comments 2016–N–2470; the docket will open on Oral presentations from the public will September 12, 2016, and remain open about the up-coming September be scheduled between approximately advisory committee meeting should be until September 23, 2016. These safety 8:30 a.m. to 9:30 a.m. Those individuals review reports are for the following submitted to Docket No. FDA–2016–N– interested in making formal oral 0567. products: presentations should notify the contact 1. BARACLUDE (entecavir) The PAC will meet to discuss the person and submit a brief statement of following products (listed by FDA 2. ISENTRESS (raltegravir potassium) the general nature of the evidence or 3. LYSTEDA (tranexamic acid) Center): arguments they wish to present, the 4. SALONPAS Pain Relief Patch (methyl 1. Center for Biologics Evaluation and names and addresses of proposed salicylate 10% and l-menthol 3%). Research participants, and an indication of the a. MENVEO (Meningococcal (groups Dated: August 11, 2016. approximate time requested to make A, C, Y and W–135) their presentation on or before August Janice M. Soreth, Oligosaccharide Diphtheria 30, 2016. Time allotted for each Acting Associate Commissioner, Special CRM197 Conjugate Vaccine) presentation may be limited. If the Medical Programs. b. IXIARO (Japanese encephalitis number of registrants requesting to [FR Doc. 2016–19589 Filed 8–16–16; 8:45 am] vaccine) speak is greater than can be reasonably BILLING CODE 4164–01–P 2. Center for Drug Evaluation and accommodated during the scheduled Research open public hearing session, FDA may a. ASACOL & ASACOL HD conduct a lottery to determine the DEPARTMENT OF HEALTH AND (mesalamine) speakers for the scheduled open public HUMAN SERVICES b. BLOXIVERZ (neostigmine hearing session. The contact person will methylsulfate) Indian Health Service notify interested persons regarding their c. DELZICOL (mesalamine) request to speak by August 31, 2016. National Indian Health Outreach and d. DORYX (doxycycline hyclate) Persons attending FDA’s advisory e. KARBINAL ER (carbinoxamine Education II Program; Correction committee meetings are advised that the maleate) Agency is not responsible for providing AGENCY: Indian Health Service, HHS. f. KEPIVANCE (palifermin) access to electrical outlets. ACTION: Notice; correction. g. SUSTIVA (efavirenz) FDA is establishing a docket for h. TOPAMAX (topiramate) public comment for the PAC meeting. SUMMARY: The Indian Health Service i. XOLAIR (omalizumab) The docket number is FDA–2016–N– published a document in the Federal 3. Center for Devices and Radiological 0567. The docket will close on August Register on July 15, 2016, for the Fiscal Health 31, 2016. Comments received on or Year 2016 National Indian Health a. ELANA SURGICAL KIT (HUD) before August 31, 2016, will be Outreach and Education II Program. The b. BERLIN HEART EXCOR® Pediatric provided to the committee. Comments notice contained an incorrect mstockstill on DSK3G9T082PROD with NOTICES Ventricular Assist Device (VAD) received after the date will be taken into Announcement Number. c. ENTERRATM THERAPY SYSTEM consideration by the Agency. FOR FURTHER INFORMATION CONTACT: Ms. d. CONTEGRA PULMONARY FDA welcomes the attendance of the Michelle EagleHawk, Deputy Director, VALVED CONDUIT public at its advisory committee Office of Direct Service and Contracting e. PLEXIMMUNE meetings and will make every effort to Tribes, 5600 Fishers Lane, Mail Stop: FDA will also provide an update of accommodate persons with disabilities. 8E17, Rockville, Maryland 20857, their additional ongoing analysis of a If you require accommodations due to a Telephone: (301) 443–1104, email: VerDate Sep<11>2014 16:39 Aug 16, 2016 Jkt 238001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\FR\FM\17AUN1.SGM 17AUN1


Document Created: 2018-02-09 11:35:07
Document Modified: 2018-02-09 11:35:07
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice, establishment of a public docket; request for comments.
DatesThe meeting will be held on September 14, 2016, from 8 a.m. to 5:30 p.m.
ContactMarieann Brill, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5154, Silver Spring, MD 20993, 240-402-3838, [email protected] or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at http://www.fda.gov/ AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. For press inquiries, please contact the Office of Media Affairs at [email protected] or 301-796-4540.
FR Citation81 FR 54813 
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR