81 FR 64914 - Armenpharm, Ltd.; Suspension of Approval of an Abbreviated New Drug Application for Chloramphenicol Capsules, 250 Milligrams; Determination That CHLOROMYCETIN (Chloramphenicol) Capsules, 50 Milligrams and 100 Milligrams, and Three Other Products Were Withdrawn From Sale for Reasons of Safety or Effectiveness
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 183 (September 21, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 183 (September 21, 2016)
| Page Range | 64914-64916 | |
| FR Document | 2016-22660 |
[Federal Register Volume 81, Number 183 (Wednesday, September 21, 2016)] [Notices] [Pages 64914-64916] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-22660] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-P-0081] Armenpharm, Ltd.; Suspension of Approval of an Abbreviated New Drug Application for Chloramphenicol Capsules, 250 Milligrams; Determination That CHLOROMYCETIN (Chloramphenicol) Capsules, 50 Milligrams and 100 Milligrams, and Three Other Products Were Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is suspending approval of abbreviated new drug application (ANDA) 060851 for chloramphenicol capsules, 250 milligrams (mg), held by Armenpharm, Ltd. (Armenpharm), 49 South Ridge Rd., P.O. Box D1400, Pomona, NY 10970. FDA has also determined that CHLOROMYCETIN (chloramphenicol) Capsules, 50 mg and 100 mg; AMPHICOL (chloramphenicol) Capsules, 100 mg; and CHLOROMYCETIN PALMITATE (chloramphenicol palmitate) Oral Suspension, 150 mg/5 milliliters (mL), were withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve ANDAs for [[Page 64915]] chloramphenicol capsules, 50 mg and 100 mg, or chloramphenicol palmitate oral suspension, 150 mg/5 mL. DATES: Effective September 21, 2016. FOR FURTHER INFORMATION CONTACT: Nicole Mueller, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6312, Silver Spring, MD 20993-0002, 301- 796-3601. SUPPLEMENTARY INFORMATION: I. Background In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA applicants must, with certain exceptions, show, among other requirements, that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the ``listed drug,'' which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the ``Approved Drug Products With Therapeutic Equivalence Evaluations,'' which is generally known as the ``Orange Book.'' Under FDA regulations, a drug is removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). Under Sec. 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that refer to the listed drug have been approved, and (3) when a person petitions for such a determination under 21 CFR 10.25(a) and 10.30. FDA may not approve an ANDA that does not refer to a listed drug. Section 505(j)(6) of the FD&C Act authorizes FDA to suspend approval of an ANDA if the listed drug relied upon has been withdrawn from sale for what FDA determines are safety or effectiveness reasons. Section 314.161(d) provides that if FDA determines that a listed drug was withdrawn from sale for safety or effectiveness reasons, the Agency will initiate proceedings under Sec. 314.153(b) (21 CFR 314.153(b)) that could result in the suspension of approval of the ANDAs that refer to the listed drug. II. Chloramphenicol Capsules, 250 mg On February 7, 2011, Armenpharm submitted a citizen petition under Sec. 10.30 (Docket No. FDA-2011-P-0081), requesting that the Agency determine whether CHLOROMYCETIN (chloramphenicol) Capsules, 250 mg (ANDA 060591), was withdrawn from sale for reasons of safety or effectiveness. CHLOROMYCETIN (chloramphenicol) Capsules, 250 mg, is the listed drug that was the basis of submission for Armenpharm's ANDA 060851 for chloramphenicol capsules, 250 mg. In the Federal Register of July 13, 2012 (77 FR 41412), FDA published a notice stating its determination under Sec. 314.161 that CHLOROMYCETIN (chloramphenicol) Capsules, 250 mg, was withdrawn from sale for reasons of safety or effectiveness. FDA also notified Armenpharm of the Agency's decision in a letter dated July 13, 2012. Pursuant to Sec. 314.153(b)(1), FDA initiated the process to suspend Armenpharm's chloramphenicol ANDA 060851 by sending a letter, dated December 3, 2015, notifying Armenpharm of the Agency's initial determination that CHLOROMYCETIN (chloramphenicol) Capsules, 250 mg, was withdrawn for reasons of safety or effectiveness and its initial decision to suspend approval of ANDA 060851 (see Docket No. FDA-2011-P- 0081). Under Sec. 314.153(b)(2), Armenpharm had 30 days from that notification in which to present written comments or information bearing on the initial decision. On December 17, 2015, Armenpharm submitted comments requesting an oral hearing under Sec. 314.153(b)(4). However, on March 17, 2016, Armenpharm withdrew its oral hearing request. Therefore, under section 505(j)(6) of the FD&C Act and Sec. 314.153(b), and under authority delegated by the Commissioner to the Director, Center for Drug Evaluation and Research, approval of ANDA 060851, and all amendments and supplements thereto, is suspended (see DATES). FDA has removed all chloramphenicol capsules, 250 mg, from the list of drug products published in the Orange Book, and no chloramphenicol capsules, 250 mg, will be listed in the Orange Book. Distribution of chloramphenicol capsules, 250 mg, in interstate commerce without an approved application is illegal and subject to regulatory action (see sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)). III. Other Discontinued Oral Chloramphenicol Drug Products FDA has become aware that the oral chloramphenicol drug products listed in the table in this document are no longer being marketed. ------------------------------------------------------------------------ Application No. Drug Applicant ------------------------------------------------------------------------ ANDA 060591.................... CHLOROMYCETIN Parkedale (chloramphenicol) Pharmaceuticals Capsules, 50 mg Inc. (formerly and 100 mg. Parke Davis Pharmaceutical Research Division of Warner Lambert Co.). ANDA 062301.................... CHLOROMYCETIN Parkedale PALMITATE Pharmaceuticals (chloramphenicol Inc. (formerly palmitate) Oral Parke Davis Suspension, Pharmaceutical Equivalent to Research Division (EQ) 150 mg base/ of Warner Lambert 5 mL. Co.). ANDA 060058.................... AMPHICOL John J. Ferrante. (chloramphenicol) Capsules, 100 mg. NDA 050152..................... CHLOROMYCETIN Parkedale PALMITATE Pharmaceuticals (chloramphenicol Inc. (formerly palmitate) Oral Parke Davis Suspension, EQ Pharmaceutical 150 mg base/5mL. Research Division of Warner Lambert Co.). ------------------------------------------------------------------------ FDA has reviewed its records and, under Sec. 314.161, has determined that the drug products listed in this table were withdrawn from sale for reasons of safety or effectiveness. We have carefully reviewed Agency records concerning the withdrawal from sale of the drug products listed in the table. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. At the time of the approval of the drug [[Page 64916]] products listed in the table, there was significant unmet medical need. With the approval of additional therapies with less severe adverse drug effects, FDA has determined that the risks associated with CHLOROMYCETIN (chloramphenicol) Capsules, 50 mg and 100 mg; AMPHICOL (chloramphenicol) Capsules, 100 mg; and CHLOROMYCETIN PALMITATE (chloramphenicol palmitate) Oral Suspension, 150 mg/5 mL, as currently labeled, outweigh the benefits. Most important, CHLOROMYCETIN (chloramphenicol) Capsules, 50 mg and 100 mg; AMPHICOL (chloramphenicol) Capsules, 100 mg; and CHLOROMYCETIN PALMITATE (chloramphenicol palmitate) Oral Suspension, 150 mg/5 mL, may cause a number of adverse reactions, the most serious being bone marrow depression (anemia, thrombocytopenia, and granulocytopenia temporally associated with treatment). A boxed warning in the prescribing information for chloramphenicol sodium succinate injection and chloramphenicol capsules and oral suspension states that serious hypoplastic anemia, thrombocytopenia, and granulocytopenia are known to occur after administration of chloramphenicol. The drug product labeling recommends extensive safety monitoring, including baseline blood studies followed by periodic blood studies approximately every 2 days during therapy. The boxed warning also describes fatal aplastic anemia associated with administration of the drug and aplastic anemia attributed to chloramphenicol that later terminated in leukemia. Published literature suggests that the risk of fatal aplastic anemia associated with oral formulations of chloramphenicol may be higher than the risk associated with the intravenous formulation. FDA has also reviewed approved labeling for the products and has determined that a Risk Evaluation and Mitigation Strategy (REMS) would be required to ensure that the benefits of the drug outweigh its risks. The REMS may include Elements to Assure Safe Use, including restricted distribution, and a Medication Guide could be required as part of the labeling. FDA has determined that additional nonclinical and possibly clinical studies of safety and efficacy would be necessary before CHLOROMYCETIN (chloramphenicol) Capsules, 50 mg and 100 mg; AMPHICOL (chloramphenicol) Capsules, 100 mg; and CHLOROMYCETIN PALMITATE (chloramphenicol palmitate) Oral Suspension, 150 mg/5 mL, could be considered for reintroduction to the market. Accordingly, the Agency will remove CHLOROMYCETIN (chloramphenicol) Capsules, 50 mg and 100 mg; AMPHICOL (chloramphenicol) Capsules, 100 mg; and CHLOROMYCETIN PALMITATE (chloramphenicol palmitate) Oral Suspension, 150 mg/5 mL, from the list of drug products published in the Orange Book. FDA will not accept or approve ANDAs that refer to these drug products. Dated: September 14, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-22660 Filed 9-20-16; 8:45 am] BILLING CODE 4164-01-P
![64914 Federal Register / Vol. 81, No. 183 / Wednesday, September 21, 2016 / Notices
comments to public dockets, see 80 FR sponsors and device manufacturers for Act of 1995 (44 U.S.C. 3501–3520). The
56469, September 18, 2015, or access coordinated development of a new collections of information in 21 CFR
the information at: http://www.fda.gov/ antimicrobial drug and an AST device; part 807, subpart E have been approved
regulatoryinformation/dockets/ explain the considerations for under OMB control number 0910–0120,
default.htm. submitting separate applications to the the collections of information in 21 CFR
Docket: For access to the docket to Center for Drug Evaluation and Research part 812 have been approved under
read background documents or the (CDER) and the Center for Devices and OMB control number 0910–0078, the
electronic and written/paper comments Radiological Health (CDRH) when collections of information in 21 CFR
received, go to http:// seeking clearance of an AST device part 312 have been approved under
www.regulations.gov and insert the coincident with, or soon following, OMB control number 0910–0014, and
docket number, found in brackets in the antimicrobial drug approval; and clarify the collections of information in 21 CFR
heading of this document, into the that the review of the new antimicrobial part 314 have been approved under
‘‘Search’’ box and follow the prompts drug product and AST device(s) will OMB control number 0910–0001. The
and/or go to the Division of Dockets remain independent, and that collections of information in the
Management, 5630 Fishers Lane, Rm. coordinated development does not guidance document ‘‘Requests for
1061, Rockville, MD 20852. influence the review timelines for either Feedback on Medical Device
An electronic copy of the guidance product. Submissions: The Pre-Submission
document is available for download II. Significance of Guidance Program and Meetings with Food and
from the Internet. See the Drug Administration Staff’’ have been
SUPPLEMENTARY INFORMATION section for This draft guidance is being issued approved under OMB control number
information on electronic access to the consistent with FDA’s good guidance 0910–0756.
guidance. Submit written requests for a practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will Dated: September 15, 2016.
single hard copy of the draft guidance Leslie Kux,
document entitled ‘‘Coordinated represent the current thinking of FDA
on coordinated development of Associate Commissioner for Policy.
Development of Antimicrobial Drugs
and Antimicrobial Susceptibility Test antimicrobial drugs and antimicrobial [FR Doc. 2016–22711 Filed 9–20–16; 8:45 am]
Devices’’ to the Office of the Center susceptibility test devices. It does not BILLING CODE 4164–01–P
Director, Guidance and Policy establish any rights for any person and
Development, Center for Devices and is not binding on FDA or the public.
Radiological Health, Food and Drug You can use an alternative approach if DEPARTMENT OF HEALTH AND
Administration, 10903 New Hampshire it satisfies the requirements of the HUMAN SERVICES
Ave., Bldg. 66, Rm. 5431, Silver Spring, applicable statutes and regulations.
Food and Drug Administration
MD 20993–0002. Alternatively, you may III. Electronic Access
submit written requests for single copies Persons interested in obtaining a copy
[Docket No. FDA–2011–P–0081]
of the guidance to the Division of Drug of the draft guidance may do so by
Information, Center for Drug Evaluation Armenpharm, Ltd.; Suspension of
downloading an electronic copy from Approval of an Abbreviated New Drug
and Research, Food and Drug the Internet. A search capability for all
Administration, 10903 New Hampshire Application for Chloramphenicol
Center for Devices and Radiological Capsules, 250 Milligrams;
Ave., Bldg. 51, Rm. 2201, Silver Spring, Health guidance documents is available
MD 20993–0002. Send one self- Determination That CHLOROMYCETIN
at http://www.fda.gov/MedicalDevices/ (Chloramphenicol) Capsules, 50
addressed adhesive label to the office DeviceRegulationandGuidance/
that you are ordering from to assist in Milligrams and 100 Milligrams, and
GuidanceDocuments/default.htm, and a Three Other Products Were Withdrawn
processing your request. search capability for all Center for Drug From Sale for Reasons of Safety or
FOR FURTHER INFORMATION CONTACT: Evaluation and Research guidance Effectiveness
Ribhi Shawar, Center for Devices and documents is available at http://
Radiological Health, Food and Drug www.fda.gov/Drugs/ AGENCY: Food and Drug Administration,
Administration, 10903 New Hampshire GuidanceCompliance HHS.
Ave., Bldg. 66, Rm. 4604, Silver Spring, RegulatoryInformation/Guidances/ ACTION: Notice.
MD 20993–0002, 301–796–6698; or default.htm. Guidance documents are
Joseph Toerner, Center for Drug also available at http:// SUMMARY: The Food and Drug
Evaluation and Research, 10903 New www.regulations.gov. Persons unable to Administration (FDA or Agency) is
Hampshire Ave., Bldg. 22, Rm. 6244, download an electronic copy of suspending approval of abbreviated new
Silver Spring, MD 20993–0002, 301– ‘‘Coordinated Development of drug application (ANDA) 060851 for
796–1400. Antimicrobial Drugs and Antimicrobial chloramphenicol capsules, 250
SUPPLEMENTARY INFORMATION: Susceptibility Test Devices’’ may send milligrams (mg), held by Armenpharm,
an email request to CDRH-Guidance@ Ltd. (Armenpharm), 49 South Ridge Rd.,
I. Background P.O. Box D1400, Pomona, NY 10970.
fda.hhs.gov to receive an electronic
This guidance, when finalized, is copy of the document. Please use the FDA has also determined that
intended to assist drug sponsors and document number 1400061 to identify CHLOROMYCETIN (chloramphenicol)
device manufacturers who are planning the guidance you are requesting. Capsules, 50 mg and 100 mg;
to develop new antimicrobial drugs and AMPHICOL (chloramphenicol)
mstockstill on DSK3G9T082PROD with NOTICES
AST devices and who seek to coordinate IV. Paperwork Reduction Act of 1995 Capsules, 100 mg; and
development of these products such that This draft guidance refers to CHLOROMYCETIN PALMITATE
the AST device could be cleared either previously approved collections of (chloramphenicol palmitate) Oral
at the time of new drug approval or information. These collections of Suspension, 150 mg/5 milliliters (mL),
shortly thereafter. information are subject to review by the were withdrawn from sale for reasons of
Specifically, the guidance intends to Office of Management and Budget safety or effectiveness. The Agency will
describe the interactions between drug (OMB) under the Paperwork Reduction not accept or approve ANDAs for
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![64916 Federal Register / Vol. 81, No. 183 / Wednesday, September 21, 2016 / Notices
products listed in the table, there was considered for reintroduction to the • Federal eRulemaking Portal: http://
significant unmet medical need. With market. www.regulations.gov. Follow the
the approval of additional therapies Accordingly, the Agency will remove instructions for submitting comments.
with less severe adverse drug effects, CHLOROMYCETIN (chloramphenicol) Comments submitted electronically,
FDA has determined that the risks Capsules, 50 mg and 100 mg; including attachments, to http://
associated with CHLOROMYCETIN AMPHICOL (chloramphenicol) www.regulations.gov will be posted to
(chloramphenicol) Capsules, 50 mg and Capsules, 100 mg; and the docket unchanged. Because your
100 mg; AMPHICOL (chloramphenicol) CHLOROMYCETIN PALMITATE comment will be made public, you are
Capsules, 100 mg; and (chloramphenicol palmitate) Oral solely responsible for ensuring that your
CHLOROMYCETIN PALMITATE Suspension, 150 mg/5 mL, from the list comment does not include any
(chloramphenicol palmitate) Oral of drug products published in the confidential information that you or a
Suspension, 150 mg/5 mL, as currently Orange Book. FDA will not accept or third party may not wish to be posted,
labeled, outweigh the benefits. Most approve ANDAs that refer to these drug such as medical information, your or
important, CHLOROMYCETIN products. anyone else’s Social Security number, or
(chloramphenicol) Capsules, 50 mg and Dated: September 14, 2016.
confidential business information, such
100 mg; AMPHICOL (chloramphenicol) as a manufacturing process. Please note
Leslie Kux,
Capsules, 100 mg; and that if you include your name, contact
Associate Commissioner for Policy. information, or other information that
CHLOROMYCETIN PALMITATE
[FR Doc. 2016–22660 Filed 9–20–16; 8:45 am] identifies you in the body of your
(chloramphenicol palmitate) Oral
Suspension, 150 mg/5 mL, may cause a BILLING CODE 4164–01–P comments, that information will be
number of adverse reactions, the most posted on http://www.regulations.gov.
serious being bone marrow depression • If you want to submit a comment
DEPARTMENT OF HEALTH AND with confidential information that you
(anemia, thrombocytopenia, and
HUMAN SERVICES do not wish to be made available to the
granulocytopenia temporally associated
with treatment). A boxed warning in the public, submit the comment as a
Food and Drug Administration written/paper submission and in the
prescribing information for
chloramphenicol sodium succinate [Docket No. FDA–2013–D–1530] manner detailed (see ‘‘Written/Paper
injection and chloramphenicol capsules Submissions’’ and ‘‘Instructions’’).
Reporting of Computational Modeling
and oral suspension states that serious Written/Paper Submissions
Studies in Medical Device
hypoplastic anemia, thrombocytopenia,
Submissions; Guidance for Industry Submit written/paper submissions as
and granulocytopenia are known to
and Food and Drug Administration follows:
occur after administration of • Mail/Hand delivery/Courier (for
Staff; Availability
chloramphenicol. The drug product written/paper submissions): Division of
labeling recommends extensive safety AGENCY: Food and Drug Administration, Dockets Management (HFA–305), Food
monitoring, including baseline blood HHS. and Drug Administration, 5630 Fishers
studies followed by periodic blood ACTION: Notice. Lane, Rm. 1061, Rockville, MD 20852.
studies approximately every 2 days • For written/paper comments
during therapy. The boxed warning also SUMMARY: The Food and Drug submitted to the Division of Dockets
describes fatal aplastic anemia Administration (FDA or Agency) is Management, FDA will post your
associated with administration of the announcing the availability of the comment, as well as any attachments,
drug and aplastic anemia attributed to guidance entitled ‘‘Reporting of except for information submitted,
chloramphenicol that later terminated Computational Modeling Studies in marked and identified, as confidential,
in leukemia. Published literature Medical Device Submissions.’’ The if submitted as detailed in
suggests that the risk of fatal aplastic purpose of this guidance document is to ‘‘Instructions.’’
anemia associated with oral provide recommendations to industry Instructions: All submissions received
formulations of chloramphenicol may on the formatting, organization, and must include the Docket No. [FDA–
be higher than the risk associated with content of reports of computational 2013–D–1530] for ‘‘Reporting of
the intravenous formulation. modeling and simulation (CM&S) Computational Modeling Studies in
FDA has also reviewed approved studies that are used as valid scientific Medical Device Submissions.’’ Received
labeling for the products and has evidence to support medical device comments will be placed in the docket
determined that a Risk Evaluation and submissions, and to assist FDA staff in and, except for those submitted as
Mitigation Strategy (REMS) would be the review of computational modeling ‘‘Confidential Submissions,’’ publicly
required to ensure that the benefits of and simulation studies by improving the viewable at http://www.regulations.gov
the drug outweigh its risks. The REMS consistency and predictability of the or at the Division of Dockets
may include Elements to Assure Safe review of CM&S and facilitating full Management between 9 a.m. and 4 p.m.,
Use, including restricted distribution, interpretation and complete review of Monday through Friday.
and a Medication Guide could be those studies. • Confidential Submissions—To
required as part of the labeling. FDA has DATES: Submit either electronic or submit a comment with confidential
determined that additional nonclinical written comments on this guidance at information that you do not wish to be
and possibly clinical studies of safety any time. General comments on Agency made publicly available, submit your
and efficacy would be necessary before guidance documents are welcome at any comments only as a written/paper
mstockstill on DSK3G9T082PROD with NOTICES
CHLOROMYCETIN (chloramphenicol) time. submission. You should submit two
Capsules, 50 mg and 100 mg; ADDRESSES: You may submit comments copies total. One copy will include the
AMPHICOL (chloramphenicol) as follows: information you claim to be confidential
Capsules, 100 mg; and with a heading or cover note that states
CHLOROMYCETIN PALMITATE Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
(chloramphenicol palmitate) Oral Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
Suspension, 150 mg/5 mL, could be following way: Agency will review this copy, including
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Document Created: 2016-09-21 01:31:45
Document Modified: 2016-09-21 01:31:45
| 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 | Effective September 21, 2016. | |
| Contact | Nicole Mueller, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6312, Silver Spring, MD 20993-0002, 301- 796-3601. | |
| FR Citation | 81 FR 64914 |
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