Emergency Use Authorization of Medical Products and Related Authorities; Guidance for Industry and Other Stakeholders; Availability, 4362-4364 [2017-00721]

Download as PDF 4362 Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Notices 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: 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 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. Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002; or to the Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., 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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. asabaliauskas on DSK3SPTVN1PROD with NOTICES FOR FURTHER INFORMATION CONTACT: Harry Schwirck, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1672, Silver Spring, MD 20993–0002, 301– 796–4271; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240–402–7911. SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 19:06 Jan 12, 2017 Jkt 241001 I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘180-Day Exclusivity: Questions and Answers.’’ This draft guidance is intended to address questions that have been raised about the provisions of the FD&C Act, which relate to 180-day exclusivity for generic drug products. These provisions provide an incentive and reward to generic drug applicants that expose themselves to the risk of patent litigation that may arise during the abbreviated new drug application (ANDA) process (see section 505(j) of the FD&C Act (21 U.S.C. 355(j)). It does so by providing for a 180-day period of marketing exclusivity vis-a-vis certain other ANDA applicants to the first applicant(s) who are eligible for the exclusivity under applicable statutory provisions (see section 505(j)(2) and (j)(5) of the FD&C Act). FDA has received a number of questions about 180-day exclusivity and has identified commonly asked questions for inclusion in the guidance. FDA expects the information provided in the guidance to enhance transparency and facilitate the development, approval, and timely marketing of generic drug products. FDA intends to update the guidance to include additional questions and answers as appropriate. The draft guidance contains questions and answers organized according to subject matter. The subject areas are: Applicable statutory scheme, first applicants, 180-day exclusivity and patents, 180-day exclusivity trigger and scope, 180-day exclusivity relinquishment and waiver, forfeiture of 180-day exclusivity, and procedural questions regarding 180-day exclusivity determinations. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘180-Day Exclusivity: Questions and Answers.’’ 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. II. Electronic Access Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, http:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 Information/Guidances/default.htm, or https://www.regulations.gov. Dated: January 9, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–00631 Filed 1–12–17; 8:45 am] BILLING CODE 4164–01–P 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. 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: SUMMARY: 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, E:\FR\FM\13JAN1.SGM 13JAN1 Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Notices asabaliauskas on DSK3SPTVN1PROD with NOTICES 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 VerDate Sep<11>2014 19:06 Jan 12, 2017 Jkt 241001 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 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, PO 00000 Frm 00085 Fmt 4703 Sfmt 4703 4363 (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). 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 prepositioning authority set forth in section 564B of the FD&C Act. Section 564 of the FD&C Act, as amended by PAHPRA, permits the 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. E:\FR\FM\13JAN1.SGM 13JAN1 asabaliauskas on DSK3SPTVN1PROD with NOTICES 4364 Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Notices 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 FDAapproved MCMs without FDA issuing EUAs, which can be a resourceintensive process. These authorities, which apply only to eligible FDAapproved medical products intended for use during a CBRN emergency, include provisions that: • Empower FDA to extend the expiration date of an eligible FDAapproved 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) VerDate Sep<11>2014 19:06 Jan 12, 2017 Jkt 241001 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Advisory Council on Alzheimer’s Research, Care, and Services; Meeting Assistant Secretary for Planning and Evaluation, HHS. ACTION: Notice of meeting. AGENCY: This notice announces the public meeting of the Advisory Council on Alzheimer’s Research, Care, and Services (Advisory Council). The Advisory Council on Alzheimer’s SUMMARY: PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 Research, Care, and Services provides advice on how to prevent or reduce the burden of Alzheimer’s disease and related dementias on people with the disease and their caregivers. The theme of the February meeting will be clinical trials for Alzheimer’s disease and related dementias and recruitment challenges. Additional presentations in the afternoon will include updates on progress towards a Care and Services Summit, federal workgroup updates, and preparation for the Advisory Council’s 2017 Recommendations, due in April 2017. DATES: The meeting will be held on Friday, February 3, 2017 from 9:00am to 5:00pm EDT. ADDRESSES: The meeting will be held in the Great Hall in the Hubert H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201. Comments: Time is allocated in the afternoon on the agenda to hear public comments. The time for oral comments will be limited to two (2) minutes per individual. In lieu of oral comments, formal written comments may be submitted for the record to Rohini Khillan, ASPE, 200 Independence Avenue SW., Room 424E, Washington, DC 20201. All comments should be submitted to napa@hhs.gov for the record and to share with the Advisory Council by January 27, 2017. Those submitting comments should identify themselves and any relevant organizational affiliations. FOR FURTHER INFORMATION CONTACT: Rohini Khillan (202) 690–5932, rohini.khillan@hhs.gov. Note: Seating may be limited. Those wishing to attend the meeting must send an email to napa@hhs.gov and put ‘‘February Meeting Attendance’’ in the Subject line by Friday, January 20, 2017 so that their names may be put on a list of expected attendees and forwarded to the security officers the Humphrey Building. Any interested member of the public who is a non-U.S. citizen should include this information at the time of registration to ensure that the appropriate security procedure to gain entry to the building is carried out. Although the meeting is open to the public, procedures governing security and the entrance to federal buildings may change without notice. If you wish to make a public comment, you must note that within your email. SUPPLEMENTARY INFORMATION: Notice of these meetings is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)). Topics of the Meeting: The theme of the February meeting will be clinical trials for Alzheimer’s disease E:\FR\FM\13JAN1.SGM 13JAN1

Agencies

[Federal Register Volume 82, Number 9 (Friday, January 13, 2017)]
[Notices]
[Pages 4362-4364]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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