82 FR 27485 - Agency Information Collection Activities; Proposed Collection; Comment Request; Establishing and Maintaining Lists of U.S. Milk Product Manufacturers/Processors With Interest in Exporting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 114 (June 15, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 114 (June 15, 2017)
| Page Range | 27485-27487 | |
| FR Document | 2017-12356 |
[Federal Register Volume 82, Number 114 (Thursday, June 15, 2017)] [Notices] [Pages 27485-27487] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-12356] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-0192] Agency Information Collection Activities; Proposed Collection; Comment Request; Establishing and Maintaining Lists of U.S. Milk Product Manufacturers/Processors With Interest in Exporting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection entitled ``Establishing and Maintaining Lists of U.S. Milk Product Manufacturers/Processors With Interest in Exporting,'' which establishes and maintains lists of U.S. milk product manufacturers and processors with interest in exporting to countries that require such lists to be maintained. The notice also solicits comments on an electronic registry that will allow manufacturers and processors of milk products to electronically request inclusion on the export lists. DATES: Submit either electronic or written comments on the collection of information by August 14, 2017. ADDRESSES: 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 August 14, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of August 14, 2017. 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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. [[Page 27486]] 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-2014-N-0192 for ``Establishing and Maintaining Lists of U.S. Milk Product Manufacturers/Processors with Interest in Exporting.'' 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 Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Establishing and Maintaining Lists of U.S. Milk Product Manufacturers/ Processors With Interest in Exporting--21 U.S.C. 371--OMB Control Number 0910-0509--Extension The United States exports a large volume and variety of foods in international trade. For certain food products, foreign governments may require assurances from the responsible authority of the country of origin of an imported food that the processor of the food is in compliance with applicable country of origin regulatory requirements. With regard to U.S. milk products, FDA is the competent U.S. food safety authority to provide this information to foreign governments. FDA provides the requested information about processors in the form of lists, which are provided to the foreign governments and posted online at http://www.fda.gov/Food/GuidanceRegulation/ImportsExports/Exporting/default.htm. Currently, FDA provides Chile, China, and the European Union (EU) with a list of U.S. milk product manufacturers/processors that: (1) Have expressed interest in exporting their products to these countries; (2) are subject to FDA's jurisdiction; and (3) are not the subject of a pending enforcement action (i.e., an injunction or seizure or a pending warning letter). FDA has published guidance documents for these countries under the authority of section 701(h) of the Federal, Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)), which authorizes the Secretary of Health and Human Services (the Secretary) to develop guidance documents with public participation presenting the views of the Secretary on matters under the jurisdiction of FDA. The guidance documents explain what information manufacturers/ processors should submit to FDA to be considered for inclusion on the lists and what criteria FDA intends to use to determine eligibility for placement on the lists. The guidance documents also explain how FDA intends to update the list and communicate any new information to the government that requested the list. Finally, the guidance documents note that the information is provided voluntarily by manufacturers/ processors with the understanding that it will be posted on FDA's external Web site and communicated to, and possibly further disseminated by, the government that requested the list; thus, FDA considers the information on the lists to be information that is not protected from disclosure under 5 U.S.C. 552(b)(4). Application for inclusion on each list is voluntary. However, some foreign governments may require inclusion on the list for acceptance of imported food. FDA recommends that U.S. manufacturers/processors that want to be placed on the export lists send FDA the following information: (1) Country to which the milk manufacturer/processor wants to export product; (2) type of milk product facility; (3) the Food Facility Registration Module number (the information collected by this module is approved under OMB control number 0910-0502); (4) name and address of the firm and the [[Page 27487]] manufacturing plant; (5) name, telephone number, and email address of the contact person; (6) list of products divided into three categories: Presently shipped, ready to ship, and available for shipment in the next 3 years; (7) identities of agencies that inspected the plant; (8) date of last inspection, plant number, and copy of last inspection notice; and (9) if other than an FDA inspection, copy of last inspection report. We request that this information be updated every 2 years. We use the information submitted by firms to determine their eligibility for placement on the export lists, which are published on our Web site. The purpose of the lists is to help foreign governments in their determinations of which U.S. milk product manufacturers and processors are eligible to export to their respective countries. FDA has recently developed an electronic registry system (Form FDA 3972) that allows milk product manufacturers and processors to electronically send a request to FDA to be included on the export lists. Manufacturers and processors that prefer to submit a paper request in a format of their own choosing will still have the option to do so. Electronic Form FDA 3972 collects the same information as is currently collected via the existing paper-based process. Draft screenshots of Form FDA 3972 and instructions are available at http://www.fda.gov/Food/GuidanceRegulation/ImportsExports/Exporting/ucm496929.htm and is entitled ``Dairy Listing Module.'' Description of Respondents: Respondents to this collection of information include U.S. milk product manufacturers/processors subject to FDA jurisdiction that wish to export to certain foreign countries that require inclusion on export lists. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Activity Number of responses per Total annual Average burden per response Total hours respondents respondent responses -------------------------------------------------------------------------------------------------------------------------------------------------------- New requests to be placed on the lists...... 2,000 1 2,000 1......................................... 2,000 Biennial update............................. 2,000 1 2,000 0.5 (30 minutes).......................... 1,000 Occasional updates.......................... 200 1 200 0.5 (30 minutes).......................... 100 ----------------------------------------------------------------------------------------------------------- Total................................... .............. .............. .............. .......................................... 3,100 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. FDA bases its estimate on the number of manufacturers/processors that have submitted new written requests, biennial updates, and occasional updates over the past 10 years. The estimate of the number of burden hours it will take a manufacturer/processor to gather the information needed to be placed on the list or update its information is based on FDA's experience with manufacturers/processors submitting similar requests. FDA believes that the information to be submitted will be readily available to manufacturers/processors. This collection is also incorporating information collected to maintain lists of eligible exporters of dairy products who wish to export to the EU from OMB control number 0910-0320, ``Request for Information from U.S. Processors that Export to the European Community.'' FDA estimates that 2,000 firms will average 60 minutes (1 hour) to submit new requests for inclusion on the list, 2,000 firms will average 30 minutes (0.5 hour) to update their information every 2 years, and 200 firms will average 30 minutes (0.5 hour) to occasionally update their information in this system. We also believe that submission via the electronic registry system will not affect the burden estimates. An electronic registry will enhance the ability of firms to more efficiently request inclusion on export lists. FDA calculates, therefore, that the total burden for this collection is 3,100 hours ((2,000 x 1) plus (2,000 x 0.5) plus (200 x 0.5)). Dated: June 9, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-12356 Filed 6-14-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices 27485
system records outside the agency, see NOTIFICATION PROCEDURES: in Exporting,’’ which establishes and
Appendix I (Authorized Disclosures and See § 4.13 of the FTC’s Rules of maintains lists of U.S. milk product
Routine Uses Applicable to All FTC Practice, 16 CFR 4.13. For additional manufacturers and processors with
Privacy Act Systems of Records), guidance, see also Appendix II (How To interest in exporting to countries that
available on the FTC’s privacy program Make A Privacy Act Request), available require such lists to be maintained. The
page at www.ftc.gov/privacy and at 73 on the FTC’s privacy program page at notice also solicits comments on an
FR 33592, 36333–36334 (June 12, 2008). www.ftc.gov/privacy and at 73 FR electronic registry that will allow
33592, 33634 (June 12, 2008). manufacturers and processors of milk
POLICIES AND PRACTICES FOR STORAGE OF
products to electronically request
RECORDS: EXEMPTIONS PROMULGATED FOR THE SYSTEM: inclusion on the export lists.
Records are maintained electronically Records contained in this system that DATES: Submit either electronic or
using a commercial software application have been placed on the FTC public written comments on the collection of
run on the agency’s internal servers. record are available upon request, as information by August 14, 2017.
Temporary paper files are destroyed discussed above. However, pursuant to ADDRESSES: You may submit comments
once the request is complete. 5 U.S.C. 552a(k)(2), records in this as follows. Please note that late,
POLICIES AND PRACTICES FOR RETRIEVAL OF
system, which reflect records that are untimely filed comments will not be
RECORDS: contained in other systems of records considered. Electronic comments must
that are designated as exempt, are be submitted on or before August 14,
Indexed by name of requesting party
exempt from the requirements of 2017. The https://www.regulations.gov
and subject matter of request. Records
subsections (c)(3), (d), (e)(1), (e)(4)(G), electronic filing system will accept
can also be searched by name, address,
(H), (I), and (f) of 5 U.S.C. 552a. See comments until midnight Eastern Time
phone number, fax number, and email
§ 4.13(m) of the FTC Rules of Practice, at the end of August 14, 2017.
of the requesting party, subject matter of
16 CFR 4.13(m). Comments received by mail/hand
the request, requestor organization,
FOIA number, and staff member HISTORY:
delivery/courier (for written/paper
assigned to the request. submissions) will be considered timely
73 FR 33592–33634 (June 12, 2008). if they are postmarked or the delivery
POLICIES AND PRACTICES FOR RETENTION AND * * * * * service acceptance receipt is on or
DISPOSAL OF RECORDS: before that date.
David C. Shonka,
Records are retained and disposed of Acting General Counsel. Electronic Submissions
in accordance with General Records
[FR Doc. 2017–12452 Filed 6–14–17; 8:45 am] Submit electronic comments in the
Schedule 4.2, issued by the National
Archives and Records Administration. BILLING CODE P following way:
• Federal eRulemaking Portal:
ADMINISTRATIVE, TECHNICAL, AND PHYSICAL https://www.regulations.gov. Follow the
SAFEGUARDS: DEPARTMENT OF HEALTH AND instructions for submitting comments.
Requests, appeals, and responses HUMAN SERVICES Comments submitted electronically,
available to the public, as described including attachments, to https://
above. Access to nonpublic system Food and Drug Administration www.regulations.gov will be posted to
records is restricted to FTC personnel or [Docket No. FDA–2014–N–0192] the docket unchanged. Because your
contractors whose responsibilities comment will be made public, you are
require access. Nonpublic paper records Agency Information Collection solely responsible for ensuring that your
are temporary, maintained in lockable Activities; Proposed Collection; comment does not include any
file cabinets or offices, and destroyed Comment Request; Establishing and confidential information that you or a
once the request is complete. Access to Maintaining Lists of U.S. Milk Product third party may not wish to be posted,
electronic records is controlled by ‘‘user Manufacturers/Processors With such as medical information, your or
ID’’ and password combination and Interest in Exporting anyone else’s Social Security number, or
other electronic access or network confidential business information, such
controls (e.g., firewalls). FTC buildings AGENCY: Food and Drug Administration, as a manufacturing process. Please note
are guarded and monitored by security HHS. that if you include your name, contact
personnel, cameras, ID checks, and ACTION: Notice. information, or other information that
other physical security measures. identifies you in the body of your
SUMMARY: The Food and Drug comments, that information will be
RECORD ACCESS PROCEDURES: Administration (FDA, we, or Agency) is posted on https://www.regulations.gov.
See § 4.13 of the FTC’s Rules of announcing an opportunity for public • If you want to submit a comment
Practice, 16 CFR 4.13. For additional comment on the proposed collection of with confidential information that you
guidance, see also Appendix II (How To certain information by the Agency. do not wish to be made available to the
Make A Privacy Act Request), available Under the Paperwork Reduction Act of public, submit the comment as a
on the FTC’s privacy program page at 1995 (PRA), Federal Agencies are written/paper submission and in the
www.ftc.gov/privacy and at 73 FR required to publish notice in the manner detailed (see ‘‘Written/Paper
33592, 33634 (June 12, 2008). Federal Register concerning each Submissions’’ and ‘‘Instructions’’).
proposed collection of information,
Written/Paper Submissions
pmangrum on DSK3GDR082PROD with NOTICES
CONTESTING RECORD PROCEDURES: including each proposed extension of an
See § 4.13 of the FTC’s Rules of existing collection of information, and Submit written/paper submissions as
Practice, 16 CFR 4.13. For additional to allow 60 days for public comment in follows:
guidance, see also Appendix II (How To response to the notice. This notice • Mail/Hand delivery/Courier (for
Make A Privacy Act Request), available solicits comments on the information written/paper submissions): Division of
on the FTC’s privacy program page at collection entitled ‘‘Establishing and Dockets Management (HFA–305), Food
www.ftc.gov/privacy and at 73 FR Maintaining Lists of U.S. Milk Product and Drug Administration, 5630 Fishers
33592, 33634 (June 12, 2008). Manufacturers/Processors With Interest Lane, Rm. 1061, Rockville, MD 20852.
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![Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices 27487
manufacturing plant; (5) name, published on our Web site. The purpose information as is currently collected via
telephone number, and email address of of the lists is to help foreign the existing paper-based process. Draft
the contact person; (6) list of products governments in their determinations of screenshots of Form FDA 3972 and
divided into three categories: Presently which U.S. milk product manufacturers instructions are available at http://
shipped, ready to ship, and available for and processors are eligible to export to www.fda.gov/Food/
shipment in the next 3 years; (7) their respective countries. GuidanceRegulation/ImportsExports/
identities of agencies that inspected the FDA has recently developed an Exporting/ucm496929.htm and is
plant; (8) date of last inspection, plant electronic registry system (Form FDA entitled ‘‘Dairy Listing Module.’’
number, and copy of last inspection 3972) that allows milk product Description of Respondents:
notice; and (9) if other than an FDA manufacturers and processors to Respondents to this collection of
inspection, copy of last inspection electronically send a request to FDA to information include U.S. milk product
report. be included on the export lists. manufacturers/processors subject to
We request that this information be Manufacturers and processors that FDA jurisdiction that wish to export to
updated every 2 years. prefer to submit a paper request in a certain foreign countries that require
We use the information submitted by format of their own choosing will still inclusion on export lists.
firms to determine their eligibility for have the option to do so. Electronic FDA estimates the burden of this
placement on the export lists, which are Form FDA 3972 collects the same collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden
Activity responses per Total hours
respondents responses per response
respondent
New requests to be placed on the lists ................... 2,000 1 2,000 1 ................................ 2,000
Biennial update ........................................................ 2,000 1 2,000 0.5 (30 minutes) ........ 1,000
Occasional updates ................................................. 200 1 200 0.5 (30 minutes) ........ 100
Total .................................................................. ........................ ........................ ........................ .................................... 3,100
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA bases its estimate on the number is 3,100 hours ((2,000 × 1) plus (2,000 submitted by Philip Morris Products
of manufacturers/processors that have × 0.5) plus (200 × 0.5)). S.A.
submitted new written requests, Dated: June 9, 2017. DATES: Submit either electronic or
biennial updates, and occasional Anna K. Abram, written comments on the application by
updates over the past 10 years. The Deputy Commissioner for Policy, Planning, December 12, 2017.
estimate of the number of burden hours Legislation, and Analysis. ADDRESSES: You may submit comments
it will take a manufacturer/processor to [FR Doc. 2017–12356 Filed 6–14–17; 8:45 am] as follows:
gather the information needed to be BILLING CODE 4164–01–P
placed on the list or update its Electronic Submissions
information is based on FDA’s Submit electronic comments in the
experience with manufacturers/ DEPARTMENT OF HEALTH AND following way:
processors submitting similar requests. HUMAN SERVICES • Federal eRulemaking Portal:
FDA believes that the information to be https://www.regulations.gov. Follow the
submitted will be readily available to Food and Drug Administration instructions for submitting comments.
manufacturers/processors. This [Docket No. FDA–2017–D–3001] Comments submitted electronically,
collection is also incorporating including attachments, to https://
information collected to maintain lists Modified Risk Tobacco Product www.regulations.gov will be posted to
of eligible exporters of dairy products Applications: Applications for IQOS the docket unchanged. Because your
who wish to export to the EU from OMB System With Marlboro Heatsticks, comment will be made public, you are
control number 0910–0320, ‘‘Request for IQOS System With Marlboro Smooth solely responsible for ensuring that your
Information from U.S. Processors that Menthol Heatsticks, and IQOS System comment does not include any
Export to the European Community.’’ With Marlboro Fresh Menthol confidential information that you or a
FDA estimates that 2,000 firms will Heatsticks Submitted by Philip Morris third party may not wish to be posted,
average 60 minutes (1 hour) to submit Products S.A.; Availability such as medical information, your or
new requests for inclusion on the list, AGENCY: Food and Drug Administration, anyone else’s Social Security number, or
2,000 firms will average 30 minutes (0.5 HHS. confidential business information, such
hour) to update their information every ACTION: Notice. as a manufacturing process. Please note
2 years, and 200 firms will average 30 that if you include your name, contact
minutes (0.5 hour) to occasionally SUMMARY: The Food and Drug information, or other information that
pmangrum on DSK3GDR082PROD with NOTICES
update their information in this system. Administration (FDA or Agency) is identifies you in the body of your
We also believe that submission via the announcing the availability for public comments, that information will be
electronic registry system will not affect comment of modified risk tobacco posted on https://www.regulations.gov.
the burden estimates. An electronic product applications (MRTPAs) for • If you want to submit a comment
registry will enhance the ability of firms IQOS system with Marlboro Heatsticks, with confidential information that you
to more efficiently request inclusion on IQOS system with Marlboro Smooth do not wish to be made available to the
export lists. FDA calculates, therefore, Menthol Heatsticks, and IQOS system public, submit the comment as a
that the total burden for this collection with Marlboro Fresh Menthol Heatsticks written/paper submission and in the
VerDate Sep<11>2014 14:10 Jun 14, 2017 Jkt 241001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\FR\FM\15JNN1.SGM 15JNN1](https://thefederalregister.org/doc/82_FR_27599/page/3.svg)
Document Created: 2017-06-15 01:03:26
Document Modified: 2017-06-15 01:03:26
| 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 either electronic or written comments on the collection of information by August 14, 2017. | |
| Contact | JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794. | |
| FR Citation | 82 FR 27485 |
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