83 FR 28238 - Foods Produced Using Animal Cell Culture Technology; Public Meeting; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 117 (June 18, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 117 (June 18, 2018)
| Page Range | 28238-28240 | |
| FR Document | 2018-12939 |
[Federal Register Volume 83, Number 117 (Monday, June 18, 2018)] [Notices] [Pages 28238-28240] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-12939] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-2155] Foods Produced Using Animal Cell Culture Technology; Public Meeting; 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 we) is announcing a public meeting entitled ``Foods Produced Using Animal Cell Culture Technology.'' FDA is holding the public meeting to provide the public with an opportunity to provide comments related to the production of foods using animal cell culture technology. DATES: The public meeting will be held on July 12, 2018, from 8:30 a.m. until 3 p.m. EST. Submit either electronic or written comments on this public meeting by September 25, 2018. See the SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: The public meeting will be held at the Food and Drug Administration, Center for Food Safety and Applied Nutrition, Wiley Auditorium, 5001 Campus Dr., College Park, MD 20740. You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before September 25, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of September 25, 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. 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): 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-2155 for ``Foods Produced Using Animal Cell Culture Technology; Public Meeting; 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.'' We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly [[Page 28239]] 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: Juanita Yates, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1731, [email protected]. SUPPLEMENTARY INFORMATION: I. Background Technological advances and consumer interest are spurring development of commercial-scale production of foods that are intended to resemble traditional meat, poultry, and seafood but are manufactured using, generally, a small amount of cells from the type of animal the food is intended to resemble. The collected cells are multiplied using nontraditional food technologies adapted from cell culture applications widely used in research and increasingly in medicine. We expect that most or all starter cells for food applications will come from living animals for the foreseeable future for commercial and marketing reasons (for example, firms currently working on developing these food applications appear to be targeting consumers motivated by animal welfare concerns). Currently, animal cells can be produced from the starter cells in bioreactors, a scaled-up application of traditional cell culture techniques. Firms are also working to commercialize processes by which cells can be cultured using biocompatible scaffolding or other techniques to permit the formation of complex tissues, similar to strategies being explored for therapeutic organ or tissue replacement. In either case, a significant technical challenge with respect to the use of animal cell culture technology to develop foods intended to resemble traditional meat, poultry, and seafood products involves the development of the growth medium used to multiply the cells and ensure that they differentiate into the correct cell types. Commercial incentives are driving research into non-animal derived components for such media instead of traditional animal-derived materials. Finally, after creation, both suspension-cultured (unstructured) and scaffold-cultured (structured) products would be further processed using traditional food technologies, including seasoning, forming, and packaging. Just as we have been in the past with respect to rapidly evolving areas of technological innovation in food, FDA will be involved in the regulation of foods generated by animal cell culture technology in light of our broad statutory authority and our extensive expertise and experience in relevant scientific areas. Currently, FDA evaluates microbial, algal, and fungal cells generated by large-scale culture and used as direct food ingredients, administers safety assessment programs for a broad array of food ingredients and foods derived from genetically engineered plants, manages safety issues associated with animal cell culture technology in therapeutic settings, and manages risks associated with the processing, manufacture, and packaging of food incorporating seafood tissues. Under the Federal Food, Drug, and Cosmetic Act, FDA has jurisdiction over ``food,'' which includes ``articles used for food'' and ``articles used for components of any such article.'' Thus, as a starting point, both substances used in the manufacture of these products of animal cell culture technology and the products themselves that will be used for food are subject to FDA's jurisdiction and applicable statutory and regulatory food safety and food labeling requirements. The use of animal cell culture technology as a method of food production and manufacturing involves many interesting issues from both technical and regulatory perspectives. FDA believes that all stakeholders will benefit from a robust and open dialogue that explores these issues and gathers relevant data and information. The primary subject of this notice is food safety, but FDA recognizes the importance of other issues related to foods produced through animal cell culture technology such as naming. Although not the primary subject of this notice, FDA welcomes comment on these other issues and expects that they will be the focus of future engagement with stakeholders and the public. II. Topics for Discussion at the Public Meeting FDA is holding the public meeting to provide the public with an opportunity to provide comments related to production of foods using animal cell culture technology. We invite interested persons, including those participating in the public meeting, to provide information on topics such as the following (a more detailed agenda will be made available prior to the meeting): FDA has evaluated a variety of foods produced by cell culture, including microbial (e.g., probiotics), algal (e.g., spirulina), and fungal products (e.g., mycoprotein). What considerations specific to animal cell culture technology would be appropriate to include in evaluation of food produced by this method of manufacture? FDA has issued guidance on how to assess the effects of significant manufacturing process changes on the safety of a food ingredient. (See ``Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that Are Color Additives'' at https://www.fda.gov/RegulatoryInformation/Guidances/ucm300661.htm.) What kinds of variations in manufacturing methods would be relevant to safety for foods produced by animal cell culture technology? FDA has a variety of pre- and postmarket programs for evaluating the safety of substances used in the production and manufacture of foods, including, for example, food additive and color additive regulations and preventive control requirements. What kinds of substances would be used in the manufacture of foods produced using animal cell culture technology and what considerations would be appropriate in evaluating the safety of these uses? Are the hazards associated with production of foods using animal cell culture technology different from those associated with traditional food production/processing (such as, for example, insanitary conditions, improper temperature controls, or control of contaminants)? Is there a need for unique control measures to address the hazards associated with production of foods using animal cell culture technology? III. Participating in the Public Meeting Registration: To register for the public meeting, please visit the following [[Page 28240]] website: https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone. Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public meeting must register by July 5, 2018. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted. If you need special accommodations due to a disability, please contact Juanita Yates (see FOR FURTHER INFORMATION CONTACT) no later than June 28, 2018. Requests for Oral Presentations: During online registration you may indicate if you wish to present during a public comment session and which topic(s) you wish to address. We will do our best to accommodate requests to make public comments. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation. Following the close of registration, we will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and will select and notify participants by July 3, 2018. Speakers will be limited to making oral remarks; there will not be an opportunity to display materials such as slide shows, videos, or other media during the meeting. All requests to make oral presentations must be received by June 28, 2018. No commercial or promotional material will be permitted to be presented or distributed at the public meeting. Streaming Webcast of the Public Meeting: This public meeting will also be webcast. Webcast participants are asked to preregister at https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm. 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 Dockets Management Staff (see ADDRESSES). A link to the transcript will also be available on the internet at https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm. Other Issues for Consideration: A summary of key information on participating in the meeting follows: Table 1--Information on Participation in the Meeting -------------------------------------------------------------------------------------------------------------------------------------------------------- Submit either Date Address Preregister Electronic address Request to make an Special electronic or oral presentation accommodations written comments -------------------------------------------------------------------------------------------------------------------------------------------------------- July 12, 2018, from 8:30 a.m. Food and Drug July 5, 2018: https:// June 28, 2018..... June 28, 2018: Submit Comments by until 3 p.m. EDT. Administration, Closing date for www.fda.gov/Food/ Closing date to September 25, Center for Food registration. NewsEvents/ request special 2018 to: https:// Safety and WorkshopsMeetings accommodations www.regulations.g Applied Conferences/ due to a ov, or Dockets Nutrition, Wiley default.htm. disability. Management Staff Auditorium, 5001 (HFA-305), Food Campus Drive, and Drug College Park, MD Administration, 20740. 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. -------------------------------------------------------------------------------------------------------------------------------------------------------- Dated: June 8, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-12939 Filed 6-15-18; 8:45 am] BILLING CODE 4164-01-P
![28238 Federal Register / Vol. 83, No. 117 / Monday, June 18, 2018 / Notices
in regulatory submissions. Technical DEPARTMENT OF HEALTH AND third party may not wish to be posted,
specifications guidances are available at: HUMAN SERVICES such as medical information, your or
https://www.fda.gov/ForIndustry/ anyone else’s Social Security number, or
DataStandards/default.htm. Food and Drug Administration confidential business information, such
[Docket No. FDA–2018–N–2155]
as a manufacturing process. Please note
II. Establishment of a Docket that if you include your name, contact
Foods Produced Using Animal Cell information, or other information that
FDA is establishing a public docket so
Culture Technology; Public Meeting; identifies you in the body of your
that anyone can share information,
Request for Comments comments, that information will be
comments, and ideas on any matters posted on https://www.regulations.gov.
related to the use of technical AGENCY: Food and Drug Administration, • If you want to submit a comment
specifications that are not specific to the HHS. with confidential information that you
documents or issues addressed in other ACTION: Notice of public meeting; do not wish to be made available to the
dockets. This information will give the request for comments. public, submit the comment as a
Agency insight into stakeholders’ written/paper submission and in the
experiences and views regarding the use SUMMARY: The Food and Drug manner detailed (see ‘‘Written/Paper
of technical specifications guidances Administration (FDA or we) is Submissions’’ and ‘‘Instructions’’).
and the data standards they contain. announcing a public meeting entitled
Written/Paper Submissions
The docket also permits anyone to share ‘‘Foods Produced Using Animal Cell
information, comments, or ideas that are Culture Technology.’’ FDA is holding Submit written/paper submissions as
specific to one or more technical the public meeting to provide the public follows:
with an opportunity to provide • Mail/Hand delivery/Courier (for
specifications guidances. Instructions
comments related to the production of written/paper submissions): Dockets
regarding how to submit comments to Management Staff (HFA–305), Food and
specific technical specifications foods using animal cell culture
technology. Drug Administration, 5630 Fishers
documents have been posted within the Lane, Rm. 1061, Rockville, MD 20852.
docket. DATES: The public meeting will be held • For written/paper comments
This docket will be open for comment on July 12, 2018, from 8:30 a.m. until 3 submitted to the Dockets Management
simultaneously with several other p.m. EST. Submit either electronic or Staff, FDA will post your comment, as
written comments on this public well as any attachments, except for
dockets that are specific to particular
meeting by September 25, 2018. See the information submitted, marked and
electronic common technical document
SUPPLEMENTARY INFORMATION section for identified, as confidential, if submitted
(eCTD) submissions and FDA data
registration date and information. as detailed in ‘‘Instructions.’’
standards documents. (For more
information on eCTD submissions and ADDRESSES: The public meeting will be Instructions: All submissions received
held at the Food and Drug must include the Docket No. FDA–
FDA data standards, see https://
Administration, Center for Food Safety 2018–N–2155 for ‘‘Foods Produced
www.fda.gov/Drugs/
and Applied Nutrition, Wiley Using Animal Cell Culture Technology;
DevelopmentApprovalProcess/ Public Meeting; Request for Comments.’’
Auditorium, 5001 Campus Dr., College
FormsSubmissionRequirements/ Park, MD 20740. Received comments, those filed in a
ElectronicSubmissions/ucm153574.htm You may submit comments as timely manner (see ADDRESSES), will be
and https://www.fda.gov/ForIndustry/ follows. Please note that late, untimely placed in the docket and, except for
DataStandards/default.htm, filed comments will not be considered. those submitted as ‘‘Confidential
respectively). Do not submit comments Electronic comments must be submitted Submissions,’’ publicly viewable at
to this general docket that have already on or before September 25, 2018. The https://www.regulations.gov or at the
been submitted to other dockets. As https://www.regulations.gov electronic Dockets Management Staff between
FDA finalizes specific documents or filing system will accept comments 9 a.m. and 4 p.m., Monday through
requests comments on specific issues for until midnight Eastern Time at the end Friday.
which another docket exists, the Agency of September 25, 2018. Comments • Confidential Submissions—To
will generally consider only those received by mail/hand delivery/courier submit a comment with confidential
comments that have been submitted to (for written/paper submissions) will be information that you do not wish to be
that specific docket. Do not submit considered timely if they are made publicly available, submit your
comments related to another specific postmarked or the delivery service comments only as a written/paper
docket to this general technical acceptance receipt is on or before that submission. You should submit two
specifications docket, as the Agency date. copies total. One copy will include the
may not consider them. FDA will not information you claim to be confidential
Electronic Submissions with a heading or cover note that states
respond directly to questions or requests
submitted to this docket but will Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
consider any submitted information in following way: CONFIDENTIAL INFORMATION.’’ We
• Federal eRulemaking Portal: will review this copy, including the
its work to develop and issue technical
https://www.regulations.gov. Follow the claimed confidential information, in our
specifications guidances.
instructions for submitting comments. consideration of comments. The second
Dated: June 12, 2018. Comments submitted electronically, copy, which will have the claimed
amozie on DSK3GDR082PROD with NOTICES1
Leslie Kux, including attachments, to https:// confidential information redacted/
Associate Commissioner for Policy. www.regulations.gov will be posted to blacked out, will be available for public
[FR Doc. 2018–12969 Filed 6–15–18; 8:45 am] the docket unchanged. Because your viewing and posted on https://
comment will be made public, you are www.regulations.gov. Submit both
BILLING CODE 4164–01–P
solely responsible for ensuring that your copies to the Dockets Management Staff.
comment does not include any If you do not wish your name and
confidential information that you or a contact information to be made publicly
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![28240 Federal Register / Vol. 83, No. 117 / Monday, June 18, 2018 / Notices
website: https://www.fda.gov/ Requests for Oral Presentations: promotional material will be permitted
Food/NewsEvents/WorkshopsMeetings During online registration you may to be presented or distributed at the
Conferences/default.htm. Please provide indicate if you wish to present during a public meeting.
complete contact information for each public comment session and which Streaming Webcast of the Public
attendee, including name, title, topic(s) you wish to address. We will do Meeting: This public meeting will also
affiliation, address, email, and our best to accommodate requests to be webcast. Webcast participants are
telephone. make public comments. Individuals and asked to preregister at https://
Registration is free and based on organizations with common interests are www.fda.gov/
space availability, with priority given to urged to consolidate or coordinate their Food/NewsEvents/WorkshopsMeetings
early registrants. Persons interested in presentations, and request time for a Conferences/default.htm.
attending this public meeting must joint presentation. Following the close Transcripts: Please be advised that as
register by July 5, 2018. Early of registration, we will determine the soon as a transcript of the public
registration is recommended because amount of time allotted to each meeting is available, it will be accessible
seating is limited; therefore, FDA may presenter and the approximate time at https://www.regulations.gov. It may
limit the number of participants from each oral presentation is to begin, and be viewed at the Dockets Management
each organization. Registrants will will select and notify participants by Staff (see ADDRESSES). A link to the
receive confirmation when they have July 3, 2018. Speakers will be limited to transcript will also be available on the
been accepted. making oral remarks; there will not be internet at https://www.fda.gov/
If you need special accommodations an opportunity to display materials such Food/NewsEvents/WorkshopsMeetings
due to a disability, please contact as slide shows, videos, or other media Conferences/default.htm.
Juanita Yates (see FOR FURTHER during the meeting. All requests to make Other Issues for Consideration: A
INFORMATION CONTACT) no later than June oral presentations must be received by summary of key information on
28, 2018. June 28, 2018. No commercial or participating in the meeting follows:
TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETING
Request to Special Submit either electronic or written
Date Address Preregister Electronic address make an oral accommodations comments
presentation
July 12, 2018, Food and Drug Ad- July 5, 2018: https://www.fda.gov/ June 28, 2018 June 28, 2018: Clos- Submit Comments by September
from 8:30 a.m. ministration, Center Closing date Food/NewsEvents/ ing date to request 25, 2018 to: https://
until 3 p.m. EDT. for Food Safety and for registration. WorkshopsMeetings special accom- www.regulations.gov, or Dock-
Applied Nutrition, Conferences/de- modations due to a ets Management Staff (HFA–
Wiley Auditorium, fault.htm. disability. 305), Food and Drug Adminis-
5001 Campus tration, 5630 Fishers Lane,
Drive, College Park, Rm. 1061, Rockville, MD
MD 20740. 20852.
Dated: June 8, 2018. or prevention of the serious cutaneous such as medical information, your or
Leslie Kux, manifestations of the heterogeneous anyone else’s Social Security number, or
Associate Commissioner for Policy. group of disorders collectively known as confidential business information, such
[FR Doc. 2018–12939 Filed 6–15–18; 8:45 am] epidermolysis bullosa (EB). There is an as a manufacturing process. Please note
BILLING CODE 4164–01–P
unmet medical need for EB patients due that if you include your name, contact
to the paucity of effective treatment information, or other information that
options. identifies you in the body of your
DEPARTMENT OF HEALTH AND DATES: Submit either electronic or comments, that information will be
HUMAN SERVICES written comments on the draft guidance posted on https://www.regulations.gov.
by August 17, 2018 to ensure that the • If you want to submit a comment
Food and Drug Administration Agency considers your comment on this with confidential information that you
draft guidance before it begins work on do not wish to be made available to the
[Docket No. FDA–2018–D–2016]
the final version of the guidance. public, submit the comment as a
Epidermolysis Bullosa: Developing ADDRESSES: You may submit comments written/paper submission and in the
Drugs for Treatment of Cutaneous on any guidance at any time as follows: manner detailed (see ‘‘Written/Paper
Manifestations; Draft Guidance for Submissions’’ and ‘‘Instructions’’).
Electronic Submissions
Industry; Availability Written/Paper Submissions
Submit electronic comments in the
AGENCY: Food and Drug Administration, following way: Submit written/paper submissions as
HHS. • Federal eRulemaking Portal: follows:
ACTION: Notice of availability. https://www.regulations.gov. Follow the
instructions for submitting comments. • Mail/Hand delivery/Courier (for
SUMMARY: The Food and Drug Comments submitted electronically, written/paper submissions): Dockets
Administration (FDA or Agency) is including attachments, to https:// Management Staff (HFA–305), Food and
amozie on DSK3GDR082PROD with NOTICES1
announcing the availability of a draft www.regulations.gov will be posted to Drug Administration, 5630 Fishers
guidance for industry entitled the docket unchanged. Because your Lane, Rm. 1061, Rockville, MD 20852.
‘‘Epidermolysis Bullosa: Developing comment will be made public, you are • For written/paper comments
Drugs for Treatment of Cutaneous solely responsible for ensuring that your submitted to the Dockets Management
Manifestations.’’ The purpose of this comment does not include any Staff, FDA will post your comment, as
draft guidance is to assist sponsors with confidential information that you or a well as any attachments, except for
the development of drugs for treatment third party may not wish to be posted, information submitted, marked and
VerDate Sep<11>2014 18:00 Jun 15, 2018 Jkt 244001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\18JNN1.SGM 18JNN1](https://thefederalregister.org/doc/83_FR_28355/page/3.svg)
Document Created: 2018-06-18 15:50:40
Document Modified: 2018-06-18 15:50:40
| 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 July 12, 2018, from 8:30 a.m. until 3 p.m. EST. Submit either electronic or written comments on this public meeting by September 25, 2018. See the SUPPLEMENTARY INFORMATION section for registration date and information. | |
| Contact | Juanita Yates, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1731, [email protected] | |
| FR Citation | 83 FR 28238 |
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