Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is announcing the availability of draft guidance entitled “Emergency Use Authorization of Medical Products.” The draft guidance explains FDA's policies for authorizing the use of an unapproved medical product or an unapproved use of an approved medical product during a declared emergency. The draft guidance is not final and is not in effect at this time. FDA also is announcing an opportunity for public comment on the proposed collection of information related to emergency use authorizations by the agency.
Submit written or electronic comments on the draft guidance and the proposed collection of information by September 6, 2005.
Submit written requests for single copies of the draft guidance to the Office of Counterterrorism Policy and Planning (HF-29), Food and Drug Administration, 5600 Fishers Lane, rm. 14C-26, Rockville, MD 20857. Send a self-addressed adhesive label to assist that office in processing your request, or fax your request to 301-827-5671. Submit written comments on the draft guidance and the proposed collection of information to the Division of Dockets Start Printed Page 38690Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. All comments should be identified with the docket number found in brackets in the heading of this document. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the draft guidance document.Start Further Info
FOR FURTHER INFORMATION CONTACT:
For information on the draft guidance: Charlotte Christin, Office of Counterterrorism Policy and Planning (HF-29), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4067.
For information on the proposed collection of information: JonnaLynn Capezzuto, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659.End Further Info End Preamble Start Supplemental Information
FDA is announcing the availability of draft guidance for industry, government agencies, and FDA staff entitled “Emergency Use Authorization of Medical Products.” This draft guidance describes the agency's general recommendations and procedures for issuance of emergency use authorizations (EUA) under section 564 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360bbb-3), which was amended by the Project BioShield Act of 2004 (Public Law 108-276).
Section 564 of the act provides for authorization of “emergency use” of a medical product, after a declaration of emergency justifying an authorization is issued by the Secretary of Health and Human Services (the Secretary) based on one of the following grounds: A determination by the Secretary of Homeland Security that there is an actual or potential “domestic emergency;” a determination by the Secretary of Defense that there is an actual or potential “military emergency;” or a determination by the Secretary that there is a public health emergency under section 319 of the Public Health Service Act that affects or has the significant potential to affect national security. The Commissioner of FDA (the Commissioner) may issue an EUA for an unapproved drug, device, or biologic, or an unapproved use of an approved drug, device, or biologic, during a declared emergency.
This draft guidance, when finalized, may be supplemented by guidance from the FDA Centers that provides additional detail on these recommendations and procedures.
II. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.
With respect to the following collection of information, FDA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
Reporting and Recordkeeping for Emergency Use Authorization of Medical Products
The act permits the Commissioner to authorize the use of unapproved medical products or unapproved uses of approved medical products during an emergency declared under section 564 of the act. The data to support issuance of an EUA must demonstrate that, based on the totality of the scientific evidence available to the Commissioner, including data from adequate and well-controlled clinical trials (if available), it is reasonable to believe that the product may be effective in diagnosing, treating, or preventing a serious or life-threatening disease or condition (21 U.S.C. 360bbb-3(c)). Although the exact type and amount of data needed to support an EUA may vary depending on the nature of the declared emergency and the nature of the candidate product, FDA recommends that a request for consideration for an EUA include scientific evidence evaluating the product's safety and effectiveness, including the adverse event profile for diagnosis, treatment, or prevention of the serious or life-threatening disease or condition, as well as data and other information on safety, effectiveness, risks and benefits, and (to the extent available) alternatives.
Under section 564, the Commissioner may establish conditions on the approval of an EUA. Section 564(e) requires the Commissioner (to the extent practicable given the circumstances of the emergency) to establish certain conditions on an authorization that the Commissioner finds necessary or appropriate to protect the public health and permits the Commissioner to establish other conditions that he finds necessary or appropriate to protect the public health. Conditions authorized by section 564(e) of the act include, for example: Requirements for information dissemination to health care providers or authorized dispensers and product recipients; adverse event monitoring and reporting; data collection and analysis; recordkeeping and records access; restrictions on product advertising, distribution, and administration; and limitations on good manufacturing practices requirements. Some conditions, the statute specifies, are mandatory to the extent practicable for authorizations of unapproved products and discretionary for authorizations of unapproved uses of approved products. Moreover, some conditions may apply to manufacturers of an EUA product, while other conditions may apply to any person who carries out any activity for which the authorization is issued. Section 564 of the act also gives the Commissioner authority to establish other conditions on an authorization that the Commissioner finds to be necessary or appropriate to protect the public health.
For purposes of estimating the burden of reporting, FDA has established six categories of respondents which include: (1) Those who file a Request for Consideration for an EUA after a determination of actual or potential emergency and, in lieu of submitting the data, provide reference to a pending or approved application; (2) those who file a Request for Consideration for an EUA and the data after a determination of actual or potential emergency, without reference to a pending or approved application; (3) those who submit data to FDA on a candidate EUA product, which is subject to a pending or approved application, prior to a Start Printed Page 38691determination of actual or potential emergency; (4) those who submit data to FDA prior to a determination of actual or potential emergency about a candidate EUA product for which there is no pending or approved application; (5) manufacturers of an unapproved EUA product who must report to FDA regarding such activity; and (6) State and local public health officials who carry out an activity related to an unapproved EUA product (e.g., administering the product to civilians) and who must report to FDA regarding such activity.
For purposes of estimating the burden of recordkeeping, FDA has calculated the anticipated burden on manufacturers of unapproved products authorized for emergency use. The agency anticipates that the Federal Government will perform some of the additional recordkeeping necessary for unapproved products (e.g., related to the administration of unapproved EUA products to military personnel). FDA also anticipates that some State and local public health officials may be required to perform additional recordkeeping (e.g., related to the administration of unapproved EUA products to civilians) and calculated a recordkeeping burden for those activities.
No burden was attributed to reporting or recordkeeping for unapproved uses of approved products, since those products already are subject to approved collections of information (adverse experience reporting for biological products is approved under OMB control number 0910-0308 through May 31, 2005; adverse drug experience reporting is approved under OMB control number 0910-0230 through September 30, 2005; and investigational new drug applications (IND) regulations are approved under OMB control number 0910-0014 through January 31, 2006) and any additional burden imposed by this proposed collection would be minimal. Thus, FDA estimates the burden of this collection of information as follows:
|No. of Respondents||Annual Frequency per Response||Total Annual Responses||Hours per Response||Total Hours|
|Request for Consideration; Pending application on file||1||1||1||15||15|
|Request for Consideration; No application pending||1||1||1||50||50|
|Pre-emergency submissions; Pending application on file||10||1||10||20||200|
|Pre-emergency submissions; No application pending||3||1||3||75||225|
|Manufacturers of an unapproved EUA product||3||4||12||2||24|
|State and local public health officials; Unapproved EUA product||30||4||120||2||240|
|1 There are no capital costs or operating and maintenance costs associated with this collection of information.|
|No. of Recordkeepers||Annual Frequency of Recordkeeping||Total Annual Records||Hours per Record||Total Hours|
|Manufacturers of an unapproved EUA product||3||4||12||25||300|
|State and local public health officials; Unapproved EUA product||30||4||120||3||360|
|1 There are no capital costs or operating and maintenance costs associated with this collection of information.|
The annual burden estimate for this information collection is 1,414 hours. The estimated reporting burden for this collection is 754 hours and the estimated recordkeeping burden is 660 hours.
III. Significance of Guidance
This draft guidance document is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency's current thinking on emergency use authorizations of medical products. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.
Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any Start Printed Page 38692mailed comments, except that individuals may submit one paper copy. Comments are to be identified 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.
V. Electronic Access
Persons with access to the Internet may obtain copies of this draft guidance at http://www.fda.gov/opacom/morechoices/industry/guidedc.htm.Start Signature
Dated: June 27, 2005.
Assistant Commissioner for Policy.
[FR Doc. 05-13121 Filed 7-01-05; 8:45 am]
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