82 FR 4362 - Emergency Use Authorization of Medical Products and Related Authorities; Guidance for Industry and Other Stakeholders; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 9 (January 13, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 9 (January 13, 2017)
| Page Range | 4362-4364 | |
| FR Document | 2017-00721 |
[Federal Register Volume 82, Number 9 (Friday, January 13, 2017)] [Notices] [Pages 4362-4364] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-00721] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-1025] Emergency Use Authorization of Medical Products and Related Authorities; Guidance for Industry and Other Stakeholders; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry and other stakeholders entitled ``Emergency Use Authorization of Medical Products and Related Authorities.'' The purpose of this guidance is to explain FDA's current thinking on the authorization of the emergency use of certain medical products under certain sections of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended or added by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA). The provisions in PAHPRA include key legal authorities to sustain and strengthen national preparedness for public health, military, and domestic emergencies involving chemical, biological, radiological, and nuclear (CBRN) agents, including emerging infectious disease threats. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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, [[Page 4363]] 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 http://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. 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-2016-D-1025 for ``Emergency Use Authorization of Medical Products and Related Authorities; Guidance for Industry and Other Stakeholders; Availability.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://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 http://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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://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. Submit written requests for single copies of the guidance to Office of Counterterrorism and Emerging Threats, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4343, Silver Spring, MD 20993-0002, 301-796-8510. Send one self- addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Carol Drew, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4320, Silver Spring, MD 20993-0002, 301-796-8510 (this is not a toll free number). SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry and other stakeholders entitled ``Emergency Use Authorization of Medical Products and Related Authorities.'' This guidance explains FDA's general recommendations and procedures applicable to the authorization of the emergency use of certain medical products under sections 564, 564A, and 564B of the FD&C Act \1\ (21 U.S.C. 360bbb-3, 360bbb-3a, and 360bbb-3b) as amended or added by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) \2\ (Pub. L. 113-5). The provisions in PAHPRA include key legal authorities to sustain and strengthen national preparedness for public health, military, and domestic emergencies involving CBRN agents, including emerging infectious disease threats such as pandemic influenza. PAHPRA clarifies and enhances FDA's authority to support emergency preparedness and response and foster the development and availability of medical products for use in these emergencies. These medical products, also referred to as ``medical countermeasures'' (MCMs) include drugs (e.g., antivirals and antidotes), biological products (e.g., vaccines, blood products, and biological therapeutics), and devices (e.g., in vitro diagnostics and personal protective equipment). --------------------------------------------------------------------------- \1\ Section 564 was first added to the FD&C Act by the Project BioShield Act of 2004 (Pub. L. 108-276). \2\ Section 3088 of the 21st Century Cures Act, signed into law by the President on December 13, 2016, (Pub. L. 114-255) amends sections 564, 564A, and 564B of the FD&C Act to add new authorities to: (1) Authorize emergency use of unapproved animal drugs; (2) make applicable other emergency use authorities (e.g., to issue emergency dispensing orders, waive compliance with current good manufacturing practices), make available Centers for Disease Control and Prevention emergency use instructions, and extend expiration dates to approved animal drugs; and (3) allow unapproved animal drugs to be held for emergency use. While much of what is described in this guidance will apply to these new authorities, this guidance does not by its terms reference them; FDA asks anyone interested in utilizing these authorities to contact FDA directly to discuss how to proceed. FDA plans to review these new authorities and address any new procedural issues raised as we develop more experience with these new authorities. --------------------------------------------------------------------------- This guidance finalizes the draft guidance ``Emergency Use Authorization of Medical Products and Related Authorities'' (April 2016) and replaces the following two guidance documents, ``Emergency Use Authorization of Medical Products'' (July 2007) and ``Emergency Use Authorization Questions and Answers'' (April 2009). The public comments received on the draft guidance have been considered and the guidance has been revised to clarify issues raised as appropriate. This guidance is intended to inform industry and government sponsors and other stakeholders involved in emergency response activities, including government agencies and public health and emergency response stakeholders, and FDA staff of FDA's general recommendations and procedures for: Issuance of Emergency Use Authorizations (EUAs) under section 564 of the FD&C Act; Implementation of the emergency use authorities set forth in section 564A of the FD&C Act; and Reliance on the governmental pre-positioning authority set forth in section 564B of the FD&C Act. Section 564 of the FD&C Act, as amended by PAHPRA, permits the [[Page 4364]] Commissioner to authorize the emergency use of an unapproved medical product or an unapproved use of an approved medical product for certain emergency circumstances after the Department of Health and Human Services (HHS) Secretary has made a declaration of an emergency or threat justifying emergency use. That declaration by the HHS Secretary must in turn be based on a determination of an emergency or potential emergency or material threat associated with the CBRN agent by, respectively, the Secretary of Homeland Security, the Secretary of Defense, or the HHS Secretary. The Commissioner may issue an EUA to allow an MCM to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by a CBRN agent, or by a product used to diagnose, treat, or prevent such diseases or conditions, when available data meet specified criteria to support such uses and there are no adequate, approved, and available alternatives. Section 564A, as added by PAHPRA, establishes streamlined mechanisms to facilitate preparedness and response activities involving certain FDA-approved MCMs without FDA issuing EUAs, which can be a resource-intensive process. These authorities, which apply only to eligible FDA-approved medical products intended for use during a CBRN emergency, include provisions that: Empower FDA to extend the expiration date of an eligible FDA-approved MCM stockpiled for use in a CBRN emergency, and establish appropriate conditions relating to such extensions, such as appropriate storage, sampling, and labeling; Permit FDA to waive otherwise applicable current good manufacturing practice requirements (e.g., storage or handling) to accommodate emergency response needs; Allow emergency dispensing of MCMs during an actual CBRN emergency event without requiring an individual prescription, or all of the information otherwise required, for each recipient of the MCM; and Permit the Centers for Disease Control and Prevention to create and issue ``emergency use instructions'' concerning the FDA- approved conditions of use for eligible products. These authorities, and the definition of eligible products to which they apply, are discussed in this guidance. To enable stakeholders to prepare for potential rapid deployment of MCMs during an actual CBRN emergency, section 564B (also added by PAHPRA) permits Federal, State, and local governments to pre-position (e.g., stockpile, forward-deploy) MCMs in anticipation of FDA approval or clearance, authorization of an investigational use, or the issuance of an EUA. This authority is also discussed in this document. II. Significance of Guidance This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on emergency use authorization of medical products and related authorities. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. III. Electronic Access Persons with access to the Internet may obtain the guidance at http://www.fda.gov/regulatoryinformation/Guidances/default.htm, http://www.regulations.gov, or http://www.fda.gov/medicalcountermeasures. IV. Paperwork Reduction Act of 1995 This guidance contains information collection provisions 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). This guidance refers to previously approved collections of information. These collections of information have been approved under OMB control numbers 0910-0308, 0910-0230, 0910-0471, 0910-0014, 0910-0078 and 0910- 0595. The collection of information in this guidance was approved under OMB control number 0910-0595. Dated: January 10, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-00721 Filed 1-12-17; 8:45 am] BILLING CODE 4164-01-P
![4362 Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Notices
second copy, which will have the I. Background Information/Guidances/default.htm, or
claimed confidential information https://www.regulations.gov.
redacted/blacked out, will be available FDA is announcing the availability of
a draft guidance for industry entitled Dated: January 9, 2017.
for public viewing and posted on Leslie Kux,
‘‘180-Day Exclusivity: Questions and
https://www.regulations.gov. Submit
Answers.’’ This draft guidance is Associate Commissioner for Policy.
both copies to the Division of Dockets
intended to address questions that have [FR Doc. 2017–00631 Filed 1–12–17; 8:45 am]
Management. If you do not wish your
been raised about the provisions of the BILLING CODE 4164–01–P
name and contact information to be
FD&C Act, which relate to 180-day
made publicly available, you can
exclusivity for generic drug products.
provide this information on the cover DEPARTMENT OF HEALTH AND
These provisions provide an incentive
sheet and not in the body of your HUMAN SERVICES
and reward to generic drug applicants
comments and you must identify this
that expose themselves to the risk of
information as ‘‘confidential.’’ Any Food and Drug Administration
patent litigation that may arise during
information marked as ‘‘confidential’’
the abbreviated new drug application [Docket No. FDA–2016–D–1025]
will not be disclosed except in (ANDA) process (see section 505(j) of
accordance with 21 CFR 10.20 and other the FD&C Act (21 U.S.C. 355(j)). It does Emergency Use Authorization of
applicable disclosure law. For more so by providing for a 180-day period of Medical Products and Related
information about FDA’s posting of marketing exclusivity vis-a-vis certain Authorities; Guidance for Industry and
comments to public dockets, see 80 FR other ANDA applicants to the first Other Stakeholders; Availability
56469, September 18, 2015, or access applicant(s) who are eligible for the
the information at: http://www.fda.gov/ exclusivity under applicable statutory AGENCY: Food and Drug Administration,
regulatoryinformation/dockets/ provisions (see section 505(j)(2) and HHS.
default.htm. (j)(5) of the FD&C Act). ACTION: Notice of availability.
Docket: For access to the docket to FDA has received a number of SUMMARY: The Food and Drug
read background documents or the questions about 180-day exclusivity and Administration (FDA or Agency) is
electronic and written/paper comments has identified commonly asked announcing the availability of a
received, go to https:// questions for inclusion in the guidance. guidance for industry and other
www.regulations.gov and insert the FDA expects the information provided stakeholders entitled ‘‘Emergency Use
docket number, found in brackets in the in the guidance to enhance transparency Authorization of Medical Products and
heading of this document, into the and facilitate the development, Related Authorities.’’ The purpose of
‘‘Search’’ box and follow the prompts approval, and timely marketing of this guidance is to explain FDA’s
and/or go to the Division of Dockets generic drug products. FDA intends to current thinking on the authorization of
Management, 5630 Fishers Lane, Rm. update the guidance to include the emergency use of certain medical
1061, Rockville, MD 20852. additional questions and answers as products under certain sections of the
Submit written requests for single appropriate. Federal Food, Drug, and Cosmetic Act
copies of the draft guidance to the The draft guidance contains questions (the FD&C Act) as amended or added by
Division of Drug Information, Center for and answers organized according to the Pandemic and All-Hazards
Drug Evaluation and Research, Food subject matter. The subject areas are: Preparedness Reauthorization Act of
and Drug Administration, 10001 New Applicable statutory scheme, first 2013 (PAHPRA). The provisions in
Hampshire Ave., Hillandale Building, applicants, 180-day exclusivity and PAHPRA include key legal authorities
4th Floor, Silver Spring, MD 20993– patents, 180-day exclusivity trigger and to sustain and strengthen national
0002; or to the Office of scope, 180-day exclusivity preparedness for public health, military,
Communication, Outreach, and relinquishment and waiver, forfeiture of and domestic emergencies involving
Development, Center for Biologics 180-day exclusivity, and procedural chemical, biological, radiological, and
Evaluation and Research, Food and questions regarding 180-day exclusivity nuclear (CBRN) agents, including
Drug Administration, 10903 New determinations. emerging infectious disease threats.
Hampshire Ave., Bldg. 71, Rm. 3128, This draft guidance is being issued DATES: Submit either electronic or
Silver Spring, MD 20993–0002. Send consistent with FDA’s good guidance written comments on Agency guidances
one self-addressed adhesive label to practices regulation (21 CFR 10.115). at any time.
assist that office in processing your The draft guidance, when finalized, will ADDRESSES: You may submit comments
requests. See the SUPPLEMENTARY represent the current thinking of FDA as follows:
INFORMATION section for electronic on ‘‘180-Day Exclusivity: Questions and
access to the draft guidance document. Answers.’’ It does not establish any Electronic Submissions
rights for any person and is not binding Submit electronic comments in the
FOR FURTHER INFORMATION CONTACT:
on FDA or the public. You can use an following way:
Harry Schwirck, Center for Drug alternative approach if it satisfies the • Federal eRulemaking Portal: http://
Evaluation and Research, Food and requirements of the applicable statutes www.regulations.gov. Follow the
Drug Administration, 10903 New and regulations. instructions for submitting comments.
Hampshire Ave., Bldg. 75, Rm. 1672,
Comments submitted electronically,
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Silver Spring, MD 20993–0002, 301– II. Electronic Access
including attachments, to http://
796–4271; or Stephen Ripley, Center for
Persons with access to the Internet www.regulations.gov will be posted to
Biologics Evaluation and Research,
may obtain the draft guidance at either the docket unchanged. Because your
Food and Drug Administration, 10903
http://www.fda.gov/Drugs/Guidance comment will be made public, you are
New Hampshire Ave., Bldg. 71, Rm.
ComplianceRegulatoryInformation/ solely responsible for ensuring that your
7301, Silver Spring, MD 20993–0002,
Guidances/default.htm, http:// comment does not include any
240–402–7911.
www.fda.gov/BiologicsBloodVaccines/ confidential information that you or a
SUPPLEMENTARY INFORMATION: GuidanceComplianceRegulatory third party may not wish to be posted,
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![4364 Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Notices
Commissioner to authorize the permits Federal, State, and local Research, Care, and Services provides
emergency use of an unapproved governments to pre-position (e.g., advice on how to prevent or reduce the
medical product or an unapproved use stockpile, forward-deploy) MCMs in burden of Alzheimer’s disease and
of an approved medical product for anticipation of FDA approval or related dementias on people with the
certain emergency circumstances after clearance, authorization of an disease and their caregivers. The theme
the Department of Health and Human investigational use, or the issuance of an of the February meeting will be clinical
Services (HHS) Secretary has made a EUA. This authority is also discussed in trials for Alzheimer’s disease and
declaration of an emergency or threat this document. related dementias and recruitment
justifying emergency use. That challenges. Additional presentations in
II. Significance of Guidance the afternoon will include updates on
declaration by the HHS Secretary must
in turn be based on a determination of This guidance is being issued progress towards a Care and Services
an emergency or potential emergency or consistent with FDA’s good guidance Summit, federal workgroup updates,
material threat associated with the practices regulation (21 CFR 10.115). and preparation for the Advisory
CBRN agent by, respectively, the The guidance represents the current Council’s 2017 Recommendations, due
Secretary of Homeland Security, the thinking of FDA on emergency use in April 2017.
Secretary of Defense, or the HHS authorization of medical products and DATES: The meeting will be held on
Secretary. The Commissioner may issue related authorities. It does not establish Friday, February 3, 2017 from 9:00am to
an EUA to allow an MCM to be used in any rights for any person and is not 5:00pm EDT.
an emergency to diagnose, treat, or binding on FDA or the public. You can ADDRESSES: The meeting will be held in
prevent serious or life-threatening use an alternative approach if it satisfies the Great Hall in the Hubert H.
diseases or conditions caused by a the requirements of the applicable Humphrey Building, 200 Independence
CBRN agent, or by a product used to statutes and regulations. Avenue SW., Washington, DC 20201.
diagnose, treat, or prevent such diseases III. Electronic Access Comments: Time is allocated in the
or conditions, when available data meet afternoon on the agenda to hear public
specified criteria to support such uses Persons with access to the Internet comments. The time for oral comments
and there are no adequate, approved, may obtain the guidance at http:// will be limited to two (2) minutes per
and available alternatives. www.fda.gov/regulatoryinformation/ individual. In lieu of oral comments,
Section 564A, as added by PAHPRA, Guidances/default.htm, http:// formal written comments may be
establishes streamlined mechanisms to www.regulations.gov, or http://www.fda. submitted for the record to Rohini
facilitate preparedness and response gov/medicalcountermeasures. Khillan, ASPE, 200 Independence
activities involving certain FDA- IV. Paperwork Reduction Act of 1995 Avenue SW., Room 424E, Washington,
approved MCMs without FDA issuing DC 20201. All comments should be
This guidance contains information submitted to napa@hhs.gov for the
EUAs, which can be a resource-
collection provisions that are subject to record and to share with the Advisory
intensive process. These authorities,
review by the Office of Management and Council by January 27, 2017. Those
which apply only to eligible FDA-
Budget (OMB) under the Paperwork submitting comments should identify
approved medical products intended for
Reduction Act of 1995 (44 U.S.C. 3501– themselves and any relevant
use during a CBRN emergency, include
3520). This guidance refers to organizational affiliations.
provisions that:
previously approved collections of
• Empower FDA to extend the FOR FURTHER INFORMATION CONTACT:
information. These collections of
expiration date of an eligible FDA- Rohini Khillan (202) 690–5932,
information have been approved under
approved MCM stockpiled for use in a rohini.khillan@hhs.gov. Note: Seating
OMB control numbers 0910–0308,
CBRN emergency, and establish may be limited. Those wishing to attend
0910–0230, 0910–0471, 0910–0014,
appropriate conditions relating to such the meeting must send an email to
0910–0078 and 0910–0595. The
extensions, such as appropriate storage, napa@hhs.gov and put ‘‘February
collection of information in this
sampling, and labeling; Meeting Attendance’’ in the Subject line
guidance was approved under OMB
• Permit FDA to waive otherwise by Friday, January 20, 2017 so that their
control number 0910–0595.
applicable current good manufacturing names may be put on a list of expected
practice requirements (e.g., storage or Dated: January 10, 2017. attendees and forwarded to the security
handling) to accommodate emergency Leslie Kux, officers the Humphrey Building. Any
response needs; Associate Commissioner for Policy. interested member of the public who is
• Allow emergency dispensing of [FR Doc. 2017–00721 Filed 1–12–17; 8:45 am] a non-U.S. citizen should include this
MCMs during an actual CBRN BILLING CODE 4164–01–P information at the time of registration to
emergency event without requiring an ensure that the appropriate security
individual prescription, or all of the procedure to gain entry to the building
information otherwise required, for each DEPARTMENT OF HEALTH AND is carried out. Although the meeting is
recipient of the MCM; and HUMAN SERVICES open to the public, procedures
• Permit the Centers for Disease governing security and the entrance to
Control and Prevention to create and Advisory Council on Alzheimer’s federal buildings may change without
issue ‘‘emergency use instructions’’ Research, Care, and Services; Meeting notice. If you wish to make a public
concerning the FDA-approved comment, you must note that within
asabaliauskas on DSK3SPTVN1PROD with NOTICES
AGENCY: Assistant Secretary for
conditions of use for eligible products. Planning and Evaluation, HHS. your email.
These authorities, and the definition of ACTION: Notice of meeting. SUPPLEMENTARY INFORMATION: Notice of
eligible products to which they apply, these meetings is given under the
are discussed in this guidance. SUMMARY: This notice announces the Federal Advisory Committee Act (5
To enable stakeholders to prepare for public meeting of the Advisory Council U.S.C. App. 2, section 10(a)(1) and
potential rapid deployment of MCMs on Alzheimer’s Research, Care, and (a)(2)). Topics of the Meeting: The
during an actual CBRN emergency, Services (Advisory Council). The theme of the February meeting will be
section 564B (also added by PAHPRA) Advisory Council on Alzheimer’s clinical trials for Alzheimer’s disease
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Document Created: 2017-01-13 02:44:23
Document Modified: 2017-01-13 02:44:23
| 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 availability. | |
| Dates | Submit either electronic or written comments on Agency guidances at any time. | |
| Contact | Carol Drew, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4320, Silver Spring, MD 20993-0002, 301-796-8510 (this is not a toll free number). | |
| FR Citation | 82 FR 4362 |
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