80 FR 26057 - Providing Regulatory Submissions in Electronic Format-Certain Human Pharmaceutical Product Applications and Related Submissions Using the Electronic Common Technical Document Specifications; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 87 (May 6, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 87 (May 6, 2015)
| Page Range | 26057-26058 | |
| FR Document | 2015-10539 |
[Federal Register Volume 80, Number 87 (Wednesday, May 6, 2015)] [Notices] [Pages 26057-26058] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-10539] [[Page 26057]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-1006] Providing Regulatory Submissions in Electronic Format--Certain Human Pharmaceutical Product Applications and Related Submissions Using the Electronic Common Technical Document Specifications; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Providing Regulatory Submissions in Electronic Format--Certain Human Pharmaceutical Product Applications and Related Submissions Using the Electronic Common Technical Document Specifications.'' The guidance is being issued in accordance with the Food and Drug Administration Safety and Innovation Act (FDASIA), which amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to require that certain submissions under the FD&C Act and Public Health Service Act (PHS Act) be submitted in electronic format, beginning no earlier than 24 months after issuance of final guidance on that topic. The guidance outlines Electronic Common Technical Document (eCTD) specification requirements for submissions to new drug applications (NDAs), abbreviated new drug applications (ANDAs), certain biologics license applications (BLAs), and certain investigational new drug applications (INDs). DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written requests for single copies of the documents to the Division of Drug Information, Center for Drug Evaluation and Research (CDER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002; or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the documents. Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Virginia Hussong, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 1132, Silver Spring, MD 20993, email: virginia.hussong@fda.hhs.gov; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911. SUPPLEMENTARY INFORMATION: I. Background FDASIA (Pub. L. 112-144), signed by the President on July 9, 2012, amended the FD&C Act to add section 745A (21 U.S.C. 379k-1), entitled ``Electronic Format for Submissions.'' Section 745A(a)(1) of the FD&C Act requires that submissions under section 505(b), (i), or (j) of the FD&C Act (21 U.S.C. 355(b), (i), or (j)) and submissions under sections 351(a) or (k) of the PHS Act (42 U.S.C. 262(a) or (k)) be submitted to FDA in electronic format no earlier than 24 months after FDA issues final guidance on that topic. In accordance with section 745A(a)(1) of the FD&C Act, FDA is issuing this guidance, announcing its determination that submission types identified in this guidance must be submitted electronically (except for submissions that are exempted) in the format specified in this guidance. This guidance (and the technical specification documents it incorporates by reference) describes how submissions under section 745A(a) of the FD&C Act must be organized and submitted in electronic format using eCTD specifications listed in the FDA Data Standards Catalog (http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm). For more information concerning how the FDA interprets section 745A(a), see the guidance for industry ``Providing Regulatory Submissions in Electronic Format--Submissions Under Section745A(a) of the Federal Food, Drug, and Cosmetic Act'' (available at http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/guidances/default.htm). The eCTD is an International Conference on Harmonization (ICH) format based on specifications developed by ICH and its member parties. FDA's CDER and CBER have been receiving submissions in the eCTD format since 2003, and eCTD has been the recommended format for electronic submissions to CDER and CBER since January 1, 2008. The majority of new electronic submissions are now received in eCTD format. This guidance finalizes and replaces the previous 2013 draft guidance on eCTD specifications. This supersedes the guidance for industry entitled ``Providing Regulatory Submissions in Electronic Format--Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications'' that was issued in June 2008. This guidance is applicable to all submissions within the scope of section 745A(a) of the FD&C Act, i.e., NDAs, ANDAs, certain BLAs, and certain INDs and all subsequent submissions, including amendments, supplements, and reports, to these submission types. This guidance is not applicable to submissions for blood and blood components, including Source Plasma. In the Federal Register of July 25, 2014 (79 FR 43494), FDA announced the availability of the revised draft guidance entitled ``Providing Regulatory Submissions in Electronic Format--Certain Human Pharmaceutical Product Applications and Related Submissions Using the Electronic Common Technical Document Specifications.'' The comment period on the revised draft guidance ended on September 23, 2014. We reviewed all comments received on the draft guidance and revised several sections of the guidance. The updates include: Section I: Clarified that in addition to this guidance and existing technical specifications, more detailed technical instructions will be issued in the form of a technical conformance guide. Section III.A: (1) Clarified which INDs and BLAs are addressed in this guidance. Specifically, a footnote was added to clarify the meaning of ``certain'' in the context of BLAs and INDs and states that the guidance is not applicable to INDs for devices that are regulated by CBER as biological products under Section 351 of the PHS Act and to INDs that are noncommercial. Further, the guidance is not applicable to those devices that are regulated by CBER as biological products under Section 351 of the PHS Act. Examples are provided in this regard. (2) Clarified that FDA considers master files to be submissions to an NDA, ANDA, BLA, or IND, and therefore to fall within the scope of requirements set forth in section 745A(a). These include new drug master files (DMFs) (21 CFR 314.420), new biological product files (BPFs) (21 CFR [[Page 26058]] 601.51), and any amendments to or annual reports on previously submitted DMFs or BPFs. This guidance also applies to submissions for drug/device combination products filed pursuant to section 505 of the FD&C Act or subsection (a) or (k) of section 351 of the PHS Act. Section Technical Specification Documents Incorporated by Reference: Provides a list of documents incorporated by reference into this guidance and provides a complete listing of technical supportive files on the FDA eCTD Web page at http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm153574.htm. We also received a comment concerning the implementation timeline for the Portable Document Format (PDF) technical specification. As discussed in the guidance for industry ``Providing Regulatory Submissions in Electronic Format--Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act,'' certain technical specifications are required no earlier than 2 years after the final guidance is published. This guidance implements the electronic submission requirements of section 745A(a) of the FD&C Act by specifying the format for electronic submissions. All submissions submitted 24 months after the publication of this guidance must use the appropriate FDA-supported eCTD specifications for NDA, ANDA, and certain BLA submissions. Certain IND submissions must use the FDA-supported eCTD specifications for electronic submissions submitted 36 months after publication of this guidance. In section 745A(a) of the FD&C Act, Congress granted explicit authorization to FDA to implement the statutory electronic submission requirements by specifying the format for such submissions in guidance. Because this guidance provides such requirements under section 745A(a) of the FD&C Act, indicated by the use of the words must or required, it is not subject to the usual restrictions in FDA's good guidance practice regulations, such as the requirement that guidances not establish legally enforceable responsibilities. See 21 CFR 10.115(d). II. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501- 3520). The guidance pertains to sponsors and applicants making regulatory submissions to FDA in electronic format for NDAs, ANDAs, BLAs, INDs, master files, and advertising and promotional labeling. The information collection discussed in the guidance is contained in our IND regulations (21 CFR part 312) and approved under OMB control number 0910-0014, our NDA regulations (including ANDAs) (21 CFR part 314) and approved under OMB control number 0910-0001, and our BLA regulations (21 CFR part 601) and approved under OMB control number 0910-0338. Sponsors and applicants have been submitting NDAs, ANDAs, BLAs, INDs, and master files electronically since 2003, and the majority of these submissions are already received in electronic format. Under section 745A(a) of the FD&C Act, sponsors and applicants are required to file most of these submissions electronically. These requirements will be phased in over 2- and 3-year periods after the issuance of this guidance. For some sponsors and applicants, there may be new costs, including capital costs or operating and maintenance costs, which would result from the requirements under FDASIA and this guidance, because some sponsors and applicants may have to upgrade eCTD specifications and/or change their method of submitting information to FDA. FDA estimates that, for some sponsors and applicants, the costs may be as follows:eCTD Publishing Software: $25,000 to $150,000 Publishing Operations Support: $50,000 to $1 million Training: $5,000 to $50,000 III. Comments Interested persons may submit either electronic comments to http://www.regulations.gov or written comments regarding this document to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the document at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or http://www.regulations.gov. Dated: April 30, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-10539 Filed 5-5-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Notices 26057
DEPARTMENT OF HEALTH AND Submit written comments to the eCTD format since 2003, and eCTD has
HUMAN SERVICES Division of Dockets Management (HFA– been the recommended format for
305), Food and Drug Administration, electronic submissions to CDER and
Food and Drug Administration 5630 Fishers Lane, Rm. 1061, Rockville, CBER since January 1, 2008. The
[Docket No. FDA–2014–N–1006] MD 20852. majority of new electronic submissions
FOR FURTHER INFORMATION CONTACT: are now received in eCTD format.
Providing Regulatory Submissions in Virginia Hussong, Center for Drug This guidance finalizes and replaces
Electronic Format—Certain Human Evaluation and Research, Food and the previous 2013 draft guidance on
Pharmaceutical Product Applications Drug Administration, 10903 New eCTD specifications. This supersedes
and Related Submissions Using the Hampshire Ave., Bldg. 22, Rm. 1132, the guidance for industry entitled
Electronic Common Technical Silver Spring, MD 20993, email: ‘‘Providing Regulatory Submissions in
Document Specifications; Guidance virginia.hussong@fda.hhs.gov; or Electronic Format—Human
for Industry; Availability Stephen Ripley, Center for Biologics Pharmaceutical Product Applications
Evaluation and Research, Food and and Related Submissions Using the
AGENCY: Food and Drug Administration, eCTD Specifications’’ that was issued in
HHS. Drug Administration, Bldg. 71, Rm.
7301, Silver Spring, MD 20993, 240– June 2008. This guidance is applicable
ACTION: Notice. to all submissions within the scope of
402–7911.
section 745A(a) of the FD&C Act, i.e.,
SUMMARY: The Food and Drug SUPPLEMENTARY INFORMATION:
NDAs, ANDAs, certain BLAs, and
Administration (FDA) is announcing the
I. Background certain INDs and all subsequent
availability of a guidance for industry
submissions, including amendments,
entitled ‘‘Providing Regulatory FDASIA (Pub. L. 112–144), signed by
supplements, and reports, to these
Submissions in Electronic Format— the President on July 9, 2012, amended
submission types. This guidance is not
Certain Human Pharmaceutical Product the FD&C Act to add section 745A (21
applicable to submissions for blood and
Applications and Related Submissions U.S.C. 379k–1), entitled ‘‘Electronic blood components, including Source
Using the Electronic Common Technical Format for Submissions.’’ Section Plasma.
Document Specifications.’’ The 745A(a)(1) of the FD&C Act requires that In the Federal Register of July 25,
guidance is being issued in accordance submissions under section 505(b), (i), or 2014 (79 FR 43494), FDA announced the
with the Food and Drug Administration (j) of the FD&C Act (21 U.S.C. 355(b), (i), availability of the revised draft guidance
Safety and Innovation Act (FDASIA), or (j)) and submissions under sections entitled ‘‘Providing Regulatory
which amended the Federal Food, Drug, 351(a) or (k) of the PHS Act (42 U.S.C. Submissions in Electronic Format—
and Cosmetic Act (the FD&C Act) to 262(a) or (k)) be submitted to FDA in Certain Human Pharmaceutical Product
require that certain submissions under electronic format no earlier than 24 Applications and Related Submissions
the FD&C Act and Public Health Service months after FDA issues final guidance Using the Electronic Common Technical
Act (PHS Act) be submitted in on that topic. Document Specifications.’’ The
electronic format, beginning no earlier In accordance with section 745A(a)(1) comment period on the revised draft
than 24 months after issuance of final of the FD&C Act, FDA is issuing this guidance ended on September 23, 2014.
guidance on that topic. The guidance guidance, announcing its determination We reviewed all comments received on
outlines Electronic Common Technical that submission types identified in this the draft guidance and revised several
Document (eCTD) specification guidance must be submitted sections of the guidance. The updates
requirements for submissions to new electronically (except for submissions include:
drug applications (NDAs), abbreviated that are exempted) in the format Section I: Clarified that in addition to
new drug applications (ANDAs), certain specified in this guidance. this guidance and existing technical
biologics license applications (BLAs), This guidance (and the technical specifications, more detailed technical
and certain investigational new drug specification documents it incorporates instructions will be issued in the form
applications (INDs). by reference) describes how of a technical conformance guide.
DATES: Submit either electronic or submissions under section 745A(a) of Section III.A: (1) Clarified which INDs
written comments on Agency guidances the FD&C Act must be organized and and BLAs are addressed in this
at any time. submitted in electronic format using guidance. Specifically, a footnote was
ADDRESSES: Submit written requests for eCTD specifications listed in the FDA added to clarify the meaning of
single copies of the documents to the Data Standards Catalog (http:// ‘‘certain’’ in the context of BLAs and
Division of Drug Information, Center for www.fda.gov/forindustry/ INDs and states that the guidance is not
Drug Evaluation and Research (CDER), datastandards/studydatastandards/ applicable to INDs for devices that are
Food and Drug Administration, 10903 default.htm). For more information regulated by CBER as biological
New Hampshire Ave., Bldg. 51, Rm. concerning how the FDA interprets products under Section 351 of the PHS
2201, Silver Spring, MD 20993–0002; or section 745A(a), see the guidance for Act and to INDs that are
the Office of Communication, Outreach industry ‘‘Providing Regulatory noncommercial. Further, the guidance is
and Development, Center for Biologics Submissions in Electronic Format— not applicable to those devices that are
Evaluation and Research (CBER), Food Submissions Under Section745A(a) of regulated by CBER as biological
and Drug Administration, 10903 New the Federal Food, Drug, and Cosmetic products under Section 351 of the PHS
Hampshire Avenue, Bldg. 71, Rm. 3128, Act’’ (available at http://www.fda.gov/ Act. Examples are provided in this
Silver Spring, MD 20993–0002. Send drugs/guidancecompliance regard. (2) Clarified that FDA considers
tkelley on DSK3SPTVN1PROD with NOTICES
one self-addressed adhesive label to regulatoryinformation/guidances/ master files to be submissions to an
assist that office in processing your default.htm). The eCTD is an NDA, ANDA, BLA, or IND, and
requests. See the SUPPLEMENTARY International Conference on therefore to fall within the scope of
INFORMATION section for electronic Harmonization (ICH) format based on requirements set forth in section
access to the documents. specifications developed by ICH and its 745A(a). These include new drug master
Submit electronic comments on the member parties. FDA’s CDER and CBER files (DMFs) (21 CFR 314.420), new
guidance to http://www.regulations.gov. have been receiving submissions in the biological product files (BPFs) (21 CFR
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![26058 Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Notices
601.51), and any amendments to or making regulatory submissions to FDA GuidanceCompliance
annual reports on previously submitted in electronic format for NDAs, ANDAs, RegulatoryInformation/Guidances/
DMFs or BPFs. This guidance also BLAs, INDs, master files, and default.htm, or http://
applies to submissions for drug/device advertising and promotional labeling. www.regulations.gov.
combination products filed pursuant to The information collection discussed in Dated: April 30, 2015.
section 505 of the FD&C Act or the guidance is contained in our IND Leslie Kux,
subsection (a) or (k) of section 351 of the regulations (21 CFR part 312) and
Associate Commissioner for Policy.
PHS Act. approved under OMB control number
Section Technical Specification [FR Doc. 2015–10539 Filed 5–5–15; 8:45 am]
0910–0014, our NDA regulations
Documents Incorporated by Reference: (including ANDAs) (21 CFR part 314) BILLING CODE 4164–01–P
Provides a list of documents and approved under OMB control
incorporated by reference into this number 0910–0001, and our BLA
guidance and provides a complete DEPARTMENT OF HEALTH AND
regulations (21 CFR part 601) and
listing of technical supportive files on HUMAN SERVICES
approved under OMB control number
the FDA eCTD Web page at http:// 0910–0338.
www.fda.gov/Drugs/ Food and Drug Administration
Sponsors and applicants have been
DevelopmentApprovalProcess/ submitting NDAs, ANDAs, BLAs, INDs,
FormsSubmissionRequirements/ [Docket No. FDA–2015–D–1245]
and master files electronically since
ElectronicSubmissions/ucm153574.htm. 2003, and the majority of these
We also received a comment Waiver of In Vivo Bioavailability and
submissions are already received in Bioequivalence Studies for Immediate-
concerning the implementation timeline electronic format. Under section
for the Portable Document Format (PDF) Release Solid Oral Dosage Forms
745A(a) of the FD&C Act, sponsors and Based on a Biopharmaceutics
technical specification. As discussed in applicants are required to file most of
the guidance for industry ‘‘Providing Classification System; Draft Guidance
these submissions electronically. These for Industry; Availability
Regulatory Submissions in Electronic requirements will be phased in over 2-
Format—Submissions Under Section and 3-year periods after the issuance of AGENCY: Food and Drug Administration,
745A(a) of the Federal Food, Drug, and this guidance. HHS.
Cosmetic Act,’’ certain technical For some sponsors and applicants, ACTION: Notice.
specifications are required no earlier there may be new costs, including
than 2 years after the final guidance is capital costs or operating and SUMMARY: The Food and Drug
published. maintenance costs, which would result Administration (FDA) is announcing the
This guidance implements the from the requirements under FDASIA availability of a draft guidance for
electronic submission requirements of and this guidance, because some industry entitled ‘‘Waiver of In Vivo
section 745A(a) of the FD&C Act by sponsors and applicants may have to Bioavailability and Bioequivalence
specifying the format for electronic upgrade eCTD specifications and/or Studies for Immediate-Release Solid
submissions. All submissions submitted change their method of submitting Oral Dosage Forms Based on a
24 months after the publication of this information to FDA. FDA estimates that, Biopharmaceutics Classification
guidance must use the appropriate FDA- for some sponsors and applicants, the System.’’ This guidance provides
supported eCTD specifications for NDA, costs may be as follows: recommendations for sponsors of
ANDA, and certain BLA submissions. • eCTD Publishing Software: $25,000 investigational new drug applications
Certain IND submissions must use the to $150,000 (INDs), and applicants that submit new
FDA-supported eCTD specifications for • Publishing Operations Support: drug applications, abbreviated new drug
electronic submissions submitted 36 $50,000 to $1 million applications (ANDAs), and supplements
months after publication of this • Training: $5,000 to $50,000 to these applications for immediate-
guidance. release (IR) solid oral dosage forms, and
In section 745A(a) of the FD&C Act, III. Comments
who wish to request a waiver of in vivo
Congress granted explicit authorization Interested persons may submit either bioavailability (BA) and/or
to FDA to implement the statutory electronic comments to http:// bioequivalence (BE) studies.
electronic submission requirements by www.regulations.gov or written
DATES: Although you can comment on
specifying the format for such comments regarding this document to
submissions in guidance. Because this the Division of Dockets Management any guidance at any time (see 21 CFR
guidance provides such requirements (see ADDRESSES). It is only necessary to 10.115(g)(5)), to ensure that the Agency
under section 745A(a) of the FD&C Act, send one set of comments. Identify considers your comment on this draft
indicated by the use of the words must comments with the docket number guidance before it begins work on the
or required, it is not subject to the usual found in brackets in the heading of this final version of the guidance, submit
restrictions in FDA’s good guidance document. Received comments may be either electronic or written comments
practice regulations, such as the seen in the Division of Dockets on the draft guidance by July 6, 2015.
requirement that guidances not establish Management between 9 a.m. and 4 p.m., ADDRESSES: Submit written requests for
legally enforceable responsibilities. See Monday through Friday, and will be single copies of the draft guidance to the
21 CFR 10.115(d). posted to the docket at http:// Division of Drug Information, Center for
www.regulations.gov. Drug Evaluation and Research, Food
II. Paperwork Reduction Act of 1995 and Drug Administration, 10001 New
IV. Electronic Access
tkelley on DSK3SPTVN1PROD with NOTICES
This guidance refers to previously Hampshire Ave., Hillandale Building,
approved collections of information that Persons with access to the Internet 4th Floor, Silver Spring, MD 20993–
are subject to review by the Office of may obtain the document at http:// 0002. Send one self-addressed adhesive
Management and Budget (OMB) under www.fda.gov/Drugs/Guidance label to assist that office in processing
the Paperwork Reduction Act of 1995 ComplianceRegulatoryInformation/ your requests. See the SUPPLEMENTARY
(44 U.S.C. 3501–3520). The guidance Guidances/default.htm, http:// INFORMATION section for electronic
pertains to sponsors and applicants www.fda.gov/BiologicsBloodVaccines/ access to the draft guidance document.
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Document Created: 2015-12-16 07:41:02
Document Modified: 2015-12-16 07:41:02
| 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 Agency guidances at any time. | |
| Contact | Virginia Hussong, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 1132, Silver Spring, MD 20993, email: [email protected]; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911. | |
| FR Citation | 80 FR 26057 |
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