83 FR 35007 - Pharmacy Compounding 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 83, Issue 142 (July 24, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 142 (July 24, 2018)
| Page Range | 35007-35009 | |
| FR Document | 2018-15782 |
[Federal Register Volume 83, Number 142 (Tuesday, July 24, 2018)] [Notices] [Pages 35007-35009] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-15782] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-2733] Pharmacy Compounding 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 meeting of the Pharmacy Compounding Advisory Committee (PCAC). The general function of the committee is to provide advice on scientific, technical, and medical issues concerning drug compounding under the Federal Food, Drug, and Cosmetic Act (FD&C Act), and, as required, any other product for which FDA has regulatory responsibility, and to make appropriate recommendations to the Agency. 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 12, 2018, from 8 a.m. to 4:30 p.m. ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993- 0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2018-N-2733. The docket will close on September 11, 2018. Submit either electronic or written comments on this public meeting by September 11, 2018. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before September 11, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of September 11, 2018. 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. Comments received on or before August 28, 2018, will be provided to the committee. Comments received after that date will be taken into consideration by FDA. 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 [[Page 35008]] 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-2018-N-2733 for ``Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.'' 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 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.'' FDA 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 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: Jay Fajiculay, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301- 796-9001, Fax: 301-847-8533, [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 FDA's website at https://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. SUPPLEMENTARY INFORMATION: Background: Section 503A of the FD&C Act (21 U.S.C. 353a) describes the conditions that must be satisfied for human drug products compounded by a licensed pharmacist in a State licensed pharmacy or a Federal facility, or a licensed physician, to be exempt from the following three sections of the FD&C Act: (1) Section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning current good manufacturing practice); (2) section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate directions for use); and (3) section 505 (21 U.S.C. 355) (concerning the approval of human drug products under new drug applications or abbreviated new drug applications). One of the conditions that must be satisfied to qualify for the exemptions under section 503A of the FD&C Act is that a bulk drug substance (active pharmaceutical ingredient) used in a compounded drug product must meet one of the following criteria: (1) Complies with the standards of an applicable United States Pharmacopoeia (USP) or National Formulary monograph, if a monograph exists, and the USP chapter on pharmacy compounding; (2) if an applicable monograph does not exist, is a component of a drug approved by the Secretary of Health and Human Services (the Secretary); or (3) if such a monograph does not exist and the drug substance is not a component of a drug approved by the Secretary, appears on a list developed by the Secretary through regulations issued by the Secretary (the ``503A Bulks List'') (see section 503A(b)(1)(A)(i) of the FD&C Act). Agenda: The committee will receive information on the following two issues to follow up on discussions from previous PCAC meetings: Balancing the criteria for the 503A bulk drug substance evaluation and compounding as it relates to dietary supplements. In addition, the committee will discuss six bulk drug substances nominated for inclusion on the 503A Bulks List. FDA will discuss the following nominated bulk drug substances: Alpha lipoic acid, coenzyme Q10, creatine monohydrate, pyridoxal 5 phosphate, choline chloride, and quercetin. The chart below identifies the use(s) FDA reviewed for each of the six bulk drug substances being discussed at this advisory committee meeting. The nominators of these substances will be invited to make a short presentation supporting the nomination. ------------------------------------------------------------------------ Drug Uses reviewed ------------------------------------------------------------------------ Alpha lipoic acid............ Diabetic neuropathy and associated pain, acute liver toxicity from Amanita spp. mushroom poisoning and other toxins, hepatitis C, cancer, cirrhosis, fibromyalgia, and muscle pain. Coenzyme Q10................. Mitochondrial disorders. Creatine monohydrate......... Mitochondrial disorders. Pyridoxal 5 phosphate........ Epilepsy and seizure disorders. Choline chloride............. Hepatic steatosis, non-alcoholic fatty liver disease, fetal alcohol spectrum disorder, and atherosclerosis. [[Page 35009]] Quercetin.................... Asthma, allergy, cancer prevention and treatment, and hypertension. ------------------------------------------------------------------------ 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 website 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 website after the meeting. Background material is available at https://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. All electronic and written submissions submitted to the Docket (see ADDRESSES) on or before August 28, 2018, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 9:30 a.m. and 9:40 a.m., 10:45 a.m. and 10:55 a.m., 11:50 a.m. and 12 noon, 1:50 p.m. and 2 p.m., 3:05 p.m. and 3:15 p.m., and 4:10 p.m. and 4:20 p.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 20, 2018. 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 21, 2018. Persons attending FDA's advisory committee meetings are advised that FDA is not responsible for providing access to electrical outlets. For press inquiries, please contact the Office of Media Affairs at [email protected] or 301-796-4540. 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 Jay Fajiculay (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://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). Dated: July 19, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-15782 Filed 7-23-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 142 / Tuesday, July 24, 2018 / Notices 35007
docket number, found in brackets in the drugs for inborn errors of metabolism recommendations to the Agency. The
heading of this document, into the that use dietary management. It does not meeting will be open to the public. FDA
‘‘Search’’ box and follow the prompts establish any rights for any person and is establishing a docket for public
and/or go to the Dockets Management is not binding on FDA or the public. comment on this document.
Staff, 5630 Fishers Lane, Rm. 1061, You can use an alternative approach if DATES: The meeting will be held on
Rockville, MD 20852. it satisfies the requirements of the September 12, 2018, from 8 a.m. to 4:30
You may submit comments on any applicable statutes and regulations. This p.m.
guidance at any time (see 21 CFR guidance is not subject to Executive ADDRESSES: FDA White Oak Campus,
10.115(g)(5)). Order 12866. 10903 New Hampshire Ave., Bldg. 31
Submit written requests for single II. Paperwork Reduction Act of 1995 Conference Center, the Great Room (Rm.
copies of the draft guidance to the 1503), Silver Spring, MD 20993–0002.
Division of Drug Information, Center for This draft guidance refers to
previously approved collections of Answers to commonly asked questions
Drug Evaluation and Research, Food including information regarding special
and Drug Administration, 10001 New information found in FDA regulations.
These collections of information are accommodations due to a disability,
Hampshire Ave., Hillandale Building, visitor parking, and transportation may
4th Floor, Silver Spring, MD 20993– subject to review by the Office of
Management and Budget (OMB) under be accessed at: https://www.fda.gov/
0002, or Office of Communication, AdvisoryCommittees/
Outreach, and Development, Center for the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections AboutAdvisoryCommittees/
Biologics Evaluation and Research, ucm408555.htm.
Food and Drug Administration, 10903 of information in 21 CFR part 312 have
been approved under OMB control FDA is establishing a docket for
New Hampshire Ave., Bldg. 71, Rm. public comment on this meeting. The
3128, Silver Spring, MD 20993–0002. number 0910–0014.
docket number is FDA–2018–N–2733.
Send one self-addressed adhesive label III. Electronic Access The docket will close on September 11,
to assist that office in processing your 2018. Submit either electronic or
Persons with access to the internet
requests. See the SUPPLEMENTARY written comments on this public
may obtain the draft guidance at either
INFORMATION section for electronic
https://www.fda.gov/Drugs/Guidance meeting by September 11, 2018. Please
access to the draft guidance document. note that late, untimely filed comments
ComplianceRegulatoryInformation/
FOR FURTHER INFORMATION CONTACT: Dina Guidances/default.htm, https:// will not be considered. Electronic
Zand, Center for Drug Evaluation and www.fda.gov/BiologicsBloodVaccines/ comments must be submitted on or
Research, Food and Drug GuidanceComplianceRegulatory before September 11, 2018. The https://
Administration, 10903 New Hampshire Information/Guidances/default.htm, or www.regulations.gov electronic filing
Ave., Bldg. 22, Rm. 5239, Silver Spring, https://www.regulations.gov. system will accept comments until
MD 20993, 240–402–2538; or Stephen midnight Eastern Time at the end of
Ripley, Center for Biologics Evaluation Dated: July 17, 2018.
September 11, 2018. Comments received
and Research, Food and Drug Leslie Kux,
by mail/hand delivery/courier (for
Administration, 10903 New Hampshire Associate Commissioner for Policy. written/paper submissions) will be
Ave., Bldg. 71, Rm. 7301, Silver Spring, [FR Doc. 2018–15777 Filed 7–23–18; 8:45 am] considered timely if they are
MD 20993–002, 240–402–7911. BILLING CODE 4164–01–P postmarked or the delivery service
SUPPLEMENTARY INFORMATION: acceptance receipt is on or before that
date.
I. Background DEPARTMENT OF HEALTH AND Comments received on or before
FDA is announcing the availability of HUMAN SERVICES August 28, 2018, will be provided to the
a draft guidance for industry entitled committee. Comments received after
Food and Drug Administration
‘‘Inborn Errors of Metabolism That Use that date will be taken into
Dietary Management: Considerations for [Docket No. FDA–2018–N–2733] consideration by FDA.
Optimizing and Standardizing Diet in You may submit comments as
Clinical Trials for Drug Product Pharmacy Compounding Advisory follows:
Development.’’ This draft guidance Committee; Notice of Meeting;
describes FDA’s current Establishment of a Public Docket; Electronic Submissions
recommendations regarding how to Request for Comments Submit electronic comments in the
optimize and standardize dietary AGENCY: Food and Drug Administration, following way:
management in clinical trials for the HHS. • Federal eRulemaking Portal:
development of drugs treating IEM for ACTION: Notice; establishment of a https://www.regulations.gov. Follow the
which dietary management is a key public docket; request for comments. instructions for submitting comments.
component of patients’ metabolic Comments submitted electronically,
control. Optimizing dietary management SUMMARY: The Food and Drug including attachments, to https://
in these patients before entry into and Administration (FDA) announces a www.regulations.gov will be posted to
during the clinical trial(s) is essential to forthcoming public advisory committee the docket unchanged. Because your
providing an accurate evaluation of the meeting of the Pharmacy Compounding comment will be made public, you are
efficacy of new drug products. Advisory Committee (PCAC). The solely responsible for ensuring that your
This draft guidance is being issued general function of the committee is to comment does not include any
jstallworth on DSKBBY8HB2PROD with NOTICES
consistent with FDA’s good guidance provide advice on scientific, technical, confidential information that you or a
practices regulation (21 CFR 10.115). and medical issues concerning drug third party may not wish to be posted,
The draft guidance, when finalized, will compounding under the Federal Food, such as medical information, your or
represent the current thinking of FDA Drug, and Cosmetic Act (FD&C Act), anyone else’s Social Security number, or
on how sponsors can optimize and and, as required, any other product for confidential business information, such
standardize dietary management for which FDA has regulatory as a manufacturing process. Please note
clinical trials in the development of responsibility, and to make appropriate that if you include your name, contact
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![Federal Register / Vol. 83, No. 142 / Tuesday, July 24, 2018 / Notices 35009
Drug Uses reviewed
Quercetin ............................................ Asthma, allergy, cancer prevention and treatment, and hypertension.
FDA intends to make background at least 7 days in advance of the residue depletion data to fulfill the
material available to the public no later meeting. national/regional requirements. This
than 2 business days before the meeting. FDA is committed to the orderly draft guidance document provides
If FDA is unable to post the background conduct of its advisory committee recommendations on what should be
material on its website prior to the meetings. Please visit our website at included in a marker residue depletion
meeting, the background material will https://www.fda.gov/ study design for aquatic food-producing
be made publicly available at the AdvisoryCommittees/ species.
location of the advisory committee AboutAdvisoryCommittees/ DATES: Submit either electronic or
meeting, and the background material ucm111462.htm for procedures on written comments on the draft guidance
will be posted on FDA’s website after public conduct during advisory by September 24, 2018 to ensure that
the meeting. Background material is committee meetings. the Agency considers your comment on
available at https://www.fda.gov/ Notice of this meeting is given under this draft guidance before it begins work
AdvisoryCommittees/Calendar/ the Federal Advisory Committee Act (5 on the final version of the guidance.
default.htm. Scroll down to the U.S.C. app. 2). ADDRESSES: You may submit comments
appropriate advisory committee meeting Dated: July 19, 2018. on any guidance at any time as follows:
link. Leslie Kux,
Procedure: Interested persons may Electronic Submissions
Associate Commissioner for Policy.
present data, information, or views, Submit electronic comments in the
[FR Doc. 2018–15782 Filed 7–23–18; 8:45 am]
orally or in writing, on issues pending following way:
BILLING CODE 4164–01–P
before the committee. All electronic and • Federal eRulemaking Portal:
written submissions submitted to the https://www.regulations.gov. Follow the
Docket (see ADDRESSES) on or before instructions for submitting comments.
DEPARTMENT OF HEALTH AND
August 28, 2018, will be provided to the Comments submitted electronically,
HUMAN SERVICES
committee. Oral presentations from the including attachments, to https://
public will be scheduled between Food and Drug Administration www.regulations.gov will be posted to
approximately 9:30 a.m. and 9:40 a.m., the docket unchanged. Because your
10:45 a.m. and 10:55 a.m., 11:50 a.m. [Docket No. FDA–2018–D–2354]
comment will be made public, you are
and 12 noon, 1:50 p.m. and 2 p.m., 3:05 solely responsible for ensuring that your
International Cooperation on
p.m. and 3:15 p.m., and 4:10 p.m. and comment does not include any
Harmonisation of Technical
4:20 p.m. Those individuals interested confidential information that you or a
Requirements for Registration of
in making formal oral presentations third party may not wish to be posted,
Veterinary Medicinal Products; Studies
should notify the contact person and such as medical information, your or
To Evaluate the Metabolism and
submit a brief statement of the general anyone else’s Social Security number, or
Residue Kinetics of Veterinary Drugs
nature of the evidence or arguments confidential business information, such
in Food-Producing Species: Marker
they wish to present, the names and as a manufacturing process. Please note
Residue Depletion Studies To
addresses of proposed participants, and that if you include your name, contact
Establish Product Withdrawal Periods
an indication of the approximate time information, or other information that
in Aquatic Species; Draft Guidance for
requested to make their presentation on identifies you in the body of your
Industry; Availability
or before August 20, 2018. Time allotted comments, that information will be
for each presentation may be limited. If AGENCY: Food and Drug Administration, posted on https://www.regulations.gov.
the number of registrants requesting to HHS. • If you want to submit a comment
speak is greater than can be reasonably ACTION: Notice of availability. with confidential information that you
accommodated during the scheduled do not wish to be made available to the
open public hearing session, FDA may SUMMARY: The Food and Drug public, submit the comment as a
conduct a lottery to determine the Administration (FDA or Agency) is written/paper submission and in the
speakers for the scheduled open public announcing the availability of a draft manner detailed (see ‘‘Written/Paper
hearing session. The contact person will guidance for industry (GFI) #257 Submissions’’ and ‘‘Instructions’’).
notify interested persons regarding their entitled ‘‘Studies to Evaluate the
request to speak by August 21, 2018. Metabolism and Residue Kinetics of Written/Paper Submissions
Persons attending FDA’s advisory Veterinary Drugs in Food-Producing Submit written/paper submissions as
committee meetings are advised that Species: Marker Residue Depletion follows:
FDA is not responsible for providing Studies to Establish Product Withdrawal • Mail/Hand Delivery/Courier (for
access to electrical outlets. Periods in Aquatic Species’’ (VICH written/paper submissions): Dockets
For press inquiries, please contact the GL57). This draft guidance has been Management Staff (HFA–305), Food and
Office of Media Affairs at fdaoma@ developed for veterinary use by the Drug Administration, 5630 Fishers
fda.hhs.gov or 301–796–4540. International Cooperation on
jstallworth on DSKBBY8HB2PROD with NOTICES
Lane, Rm. 1061, Rockville, MD 20852.
FDA welcomes the attendance of the Harmonisation of Technical • For written/paper comments
public at its advisory committee Requirements for Registration of submitted to the Dockets Management
meetings and will make every effort to Veterinary Medicinal Products (VICH). Staff, FDA will post your comment, as
accommodate persons with disabilities. This VICH draft guidance document is well as any attachments, except for
If you require accommodations due to a intended to provide study design information submitted, marked and
disability, please contact Jay Fajiculay recommendations that will facilitate the identified, as confidential, if submitted
(see FOR FURTHER INFORMATION CONTACT) universal acceptance of the generated as detailed in ‘‘Instructions.’’
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Document Created: 2018-07-24 00:10:48
Document Modified: 2018-07-24 00:10:48
| 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; establishment of a public docket; request for comments. | |
| Dates | The meeting will be held on September 12, 2018, from 8 a.m. to 4:30 p.m. | |
| Contact | Jay Fajiculay, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301- 796-9001, Fax: 301-847-8533, [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 FDA's website at https://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. | |
| FR Citation | 83 FR 35007 |
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