Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance: Emergency Use Authorization of Medical Products, 12739-12741 [2016-05390]

Download as PDF Federal Register / Vol. 81, No. 47 / Thursday, March 10, 2016 / Notices 12739 TABLE 2—AREAS OF INTEREST—OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH—Continued Focus area Specific areas of interest Radiation therapy equipment ................................................................... Observe radiation therapy equipment (e.g., linear accelerator, proton beam therapy, brachytherapy) testing and evaluation. B. Site Selection CDRH will be responsible for CDRH staff travel expenses associated with the site visits. CDRH will not provide funds to support the training provided by the site to the ELP. Selection of potential facilities will be based on CDRH’s priorities for staff training and resources available to fund this program. In addition to logistical and other resource factors, all sites must have a successful compliance record with FDA or another Agency with which FDA has a memorandum of understanding. If a site visit involves a visit to a separate physical location of another firm under contract with the site, that firm must agree to participate in the ELP and must also have a satisfactory compliance history. mstockstill on DSK4VPTVN1PROD with NOTICES III. Request To Participate Submit requests for participation with the docket number found in the brackets in the heading of this document. Received requests may be seen in the Division of Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday. The request should include a description of your facility relative to focus areas described in table 1 or 2. Please include the Area of Interest (see table 1 or 2) that the site visit will demonstrate to CDRH staff, a contact person, site visit location(s), length of site visit, proposed dates, and maximum number of CDRH staff that can be accommodated during a site visit. Requests submitted without this minimum information will not be considered. Additional information regarding the CDRH ELP, including a sample request and an example of the site visit agenda, is available on CDRH’s Web site at: https://www.fda.gov/scienceresearch/ sciencecareeropportunities/ ucm380676.htm. Dated: March 4, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–05387 Filed 3–9–16; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 17:55 Mar 09, 2016 Jkt 238001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0976] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance: Emergency Use Authorization of Medical Products AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by April 11, 2016. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0595. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUMMARY: Emergency Use Authorization of Medical Products and Related Authorities; Guidance for Industry and Public Health Stakeholders OMB Control Number 0910–0595–Extension The guidance describes the Agency’s general recommendations and procedures for issuance of emergency PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 use authorizations (EUA) under section 564 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360bbb–3), which was amended by the Project BioShield Act of 2004 (Pub. L. 108–276). The FD&C 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 FD&C 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 wellcontrolled clinical trials (if available), it is reasonable to believe that the product may be effective in diagnosing, treating, or preventing a serious or lifethreatening 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 of the FD&C Act, the FDA Commissioner may establish conditions on the authorization. Section 564(e) requires the FDA 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 FDA Commissioner to establish other conditions that she finds necessary or appropriate to protect the public health. Conditions authorized by section 564(e) of the FD&C 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 E:\FR\FM\10MRN1.SGM 10MRN1 12740 Federal Register / Vol. 81, No. 47 / Thursday, March 10, 2016 / Notices 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 FD&C Act also gives the FDA Commissioner authority to establish other conditions on an authorization that she finds to be necessary or appropriate to protect the public health. For purposes of estimating the annual burden of reporting (table 1), FDA has established four categories of respondents: (1) Those who file a request for FDA to issue an EUA or a substantive amendment to an EUA that has previously been issued, assuming that a requisite declaration under section 564 of the FD&C Act has been made and criteria for issuance have been met; (2) those who submit a request for FDA to review information/ data (i.e., a pre-EUA package) for a candidate EUA product or a substantive amendment to an existing pre-EUA package for preparedness purposes; (3) manufacturers who carry out an activity related to an unapproved EUA product (e.g., administering product, disseminating information) who must report to FDA regarding such activity; and (4) public health authorities (e.g., State, local) who carry out an activity (e.g., administering product, disseminating information) related to an unapproved EUA product who must report to FDA regarding such activity. In some cases, manufacturers directly submit EUA requests. Often a Federal Government entity (e.g., the Centers for Disease Control and Prevention, Department of Defense) requests that FDA issue an EUA and submits preEUA packages for FDA to review. In many of these cases, manufacturer respondents inform these requests and submissions, which are the activities that form the basis of the estimated reporting burdens. However, in some cases the Federal Government is the sole respondent; manufacturers do not inform these requests or submissions. FDA estimates minimal burden when the Federal Government performs the relevant activities. In addition to variability based on whether there is an active manufacturer respondent, other factors also inject significant variability in estimates for annual reporting burdens. A second factor is the type of product. For example, FDA estimates greater burden for novel therapeutics than for certain unapproved uses of approved products. A third significant factor that injects variability is the type of submission. For example, FDA estimates greater burden for ‘‘original’’ EUA and pre-EUA submissions than for amendments to them, and FDA estimates minimal burden to issue an EUA when there is a previously reviewed pre-EUA package or investigational application. For purposes of estimating the reporting burden, FDA has calculated the anticipated burden on manufacturers based on the anticipated types of responses (i.e., estimated manufacturer input), types of product, and types of submission that comprise the described reporting activities. For purposes of estimating the annual burden of recordkeeping, FDA has also calculated the anticipated burden on manufacturers and public health officials associated with administration of unapproved products authorized for emergency use, recognizing that the Federal Government will perform much of the recordkeeping related to administration of such products (table 2). No burden was attributed to reporting or recordkeeping for unapproved uses of approved products, since those products are already subject to approved collections of information (i.e., adverse experience reporting for biological products is approved under OMB control number 0910–0308 through February 28, 2018; adverse drug experience reporting is approved under OMB control number 0910–0230 through December 31, 2018; adverse device experience reporting is approved under OMB control number 0910–0471 through May 31, 2017; investigational new drug application regulations are approved under OMB control number 0910–0014 through February 28, 2019; and investigational device exemption reporting is approved under OMB control number 0910–0078 through March 31, 2016). Any additional burden imposed by this proposed collection would be minimal. In the Federal Register of December 23, 2015 (80 FR 79905), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Total .............................................................................. mstockstill on DSK4VPTVN1PROD with NOTICES Manufacturer, Request to Issue an EUA or a Substantive Amendment to an Existing EUA ...................................... Manufacturer, Request for FDA Review of a Pre-EUA Package or an Amendment Thereto ................................ Manufacturer of an Unapproved EUA Product; Conditions of Authorization ................................................................ Public Health Authority; Unapproved EUA Product; Conditions of Authorization ........................................................ 1 Number of responses per respondent Number of respondents Type of respondent Average burden per response Total annual responses Total hours 6 3 18 45 810 13 6 78 34 2,652 5 2 10 2 20 30 3 90 2 180 ........................ ........................ ........................ ........................ 3,662 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers Type of respondent Manufacturers of an Unapproved EUA Product .................. VerDate Sep<11>2014 17:55 Mar 09, 2016 Jkt 238001 PO 00000 Frm 00061 Number of records per recordkeeper 5 Fmt 4703 Sfmt 4703 Total annual records 2 E:\FR\FM\10MRN1.SGM Average burden per recordkeeping 10 10MRN1 25 Total hours 250 12741 Federal Register / Vol. 81, No. 47 / Thursday, March 10, 2016 / Notices TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued Number of recordkeepers Type of respondent Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours Public Health Authorities; Unapproved EUA Product .......... 30 3 90 3 270 Total .............................................................................. ........................ ........................ ........................ ........................ 520 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: March 7, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–05390 Filed 3–9–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–E–2349] Determination of Regulatory Review Period for Purposes of Patent Extension; OPSUMIT AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined the regulatory review period for OPSUMIT and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product. DATES: Anyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by May 9, 2016. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by September 6, 2016. See ‘‘Petitions’’ in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows: mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, VerDate Sep<11>2014 17:55 Mar 09, 2016 Jkt 238001 including attachments, to https:// 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, 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 https://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– 2014–E–2349 ‘‘For Determination of Regulatory Review Period for Purposes of Patent Extension; OPSUMIT.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://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 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 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 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: https://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. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301–796–3600. SUPPLEMENTARY INFORMATION: I. Background The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) and the Generic Animal Drug and Patent Term E:\FR\FM\10MRN1.SGM 10MRN1

Agencies

[Federal Register Volume 81, Number 47 (Thursday, March 10, 2016)]
[Notices]
[Pages 12739-12741]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05390]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0976]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance: Emergency 
Use Authorization of Medical Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by April 
11, 2016.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0595. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Emergency Use Authorization of Medical Products and Related 
Authorities; Guidance for Industry and Public Health Stakeholders OMB 
Control Number 0910-0595-Extension

    The 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 FD&C Act) 
(21 U.S.C. 360bbb-3), which was amended by the Project BioShield Act of 
2004 (Pub. L. 108-276). The FD&C 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 FD&C 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 of the FD&C Act, the FDA Commissioner may 
establish conditions on the authorization. Section 564(e) requires the 
FDA 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 FDA Commissioner to establish other conditions 
that she finds necessary or appropriate to protect the public health. 
Conditions authorized by section 564(e) of the FD&C 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

[[Page 12740]]

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 FD&C Act also gives the FDA Commissioner authority to establish 
other conditions on an authorization that she finds to be necessary or 
appropriate to protect the public health.
    For purposes of estimating the annual burden of reporting (table 
1), FDA has established four categories of respondents: (1) Those who 
file a request for FDA to issue an EUA or a substantive amendment to an 
EUA that has previously been issued, assuming that a requisite 
declaration under section 564 of the FD&C Act has been made and 
criteria for issuance have been met; (2) those who submit a request for 
FDA to review information/data (i.e., a pre-EUA package) for a 
candidate EUA product or a substantive amendment to an existing pre-EUA 
package for preparedness purposes; (3) manufacturers who carry out an 
activity related to an unapproved EUA product (e.g., administering 
product, disseminating information) who must report to FDA regarding 
such activity; and (4) public health authorities (e.g., State, local) 
who carry out an activity (e.g., administering product, disseminating 
information) related to an unapproved EUA product who must report to 
FDA regarding such activity.
    In some cases, manufacturers directly submit EUA requests. Often a 
Federal Government entity (e.g., the Centers for Disease Control and 
Prevention, Department of Defense) requests that FDA issue an EUA and 
submits pre-EUA packages for FDA to review. In many of these cases, 
manufacturer respondents inform these requests and submissions, which 
are the activities that form the basis of the estimated reporting 
burdens. However, in some cases the Federal Government is the sole 
respondent; manufacturers do not inform these requests or submissions. 
FDA estimates minimal burden when the Federal Government performs the 
relevant activities. In addition to variability based on whether there 
is an active manufacturer respondent, other factors also inject 
significant variability in estimates for annual reporting burdens. A 
second factor is the type of product. For example, FDA estimates 
greater burden for novel therapeutics than for certain unapproved uses 
of approved products. A third significant factor that injects 
variability is the type of submission. For example, FDA estimates 
greater burden for ``original'' EUA and pre-EUA submissions than for 
amendments to them, and FDA estimates minimal burden to issue an EUA 
when there is a previously reviewed pre-EUA package or investigational 
application. For purposes of estimating the reporting burden, FDA has 
calculated the anticipated burden on manufacturers based on the 
anticipated types of responses (i.e., estimated manufacturer input), 
types of product, and types of submission that comprise the described 
reporting activities.
    For purposes of estimating the annual burden of recordkeeping, FDA 
has also calculated the anticipated burden on manufacturers and public 
health officials associated with administration of unapproved products 
authorized for emergency use, recognizing that the Federal Government 
will perform much of the recordkeeping related to administration of 
such products (table 2).
    No burden was attributed to reporting or recordkeeping for 
unapproved uses of approved products, since those products are already 
subject to approved collections of information (i.e., adverse 
experience reporting for biological products is approved under OMB 
control number 0910-0308 through February 28, 2018; adverse drug 
experience reporting is approved under OMB control number 0910-0230 
through December 31, 2018; adverse device experience reporting is 
approved under OMB control number 0910-0471 through May 31, 2017; 
investigational new drug application regulations are approved under OMB 
control number 0910-0014 through February 28, 2019; and investigational 
device exemption reporting is approved under OMB control number 0910-
0078 through March 31, 2016). Any additional burden imposed by this 
proposed collection would be minimal.
    In the Federal Register of December 23, 2015 (80 FR 79905), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
       Type of respondent            Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Manufacturer, Request to Issue                 6               3              18              45             810
 an EUA or a Substantive
 Amendment to an Existing EUA...
Manufacturer, Request for FDA                 13               6              78              34           2,652
 Review of a Pre-EUA Package or
 an Amendment Thereto...........
Manufacturer of an Unapproved                  5               2              10               2              20
 EUA Product; Conditions of
 Authorization..................
Public Health Authority;                      30               3              90               2             180
 Unapproved EUA Product;
 Conditions of Authorization....
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           3,662
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
       Type of respondent            Number of      records per    Total annual     burden per      Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
Manufacturers of an Unapproved                 5               2              10              25             250
 EUA Product....................

[[Page 12741]]

 
Public Health Authorities;                    30               3              90               3             270
 Unapproved EUA Product.........
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             520
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: March 7, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05390 Filed 3-9-16; 8:45 am]
 BILLING CODE 4164-01-P
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