49612 Federal Register / Vol. 82, No. 206 / Thursday, October 26, 2017 / Notices 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: Extension of a currently 

approved collection; 

Title of Information Collection: 

National Provider Identifier (NPI) 

Application and Update Form and 

Supporting Regulations in 45 CFR 

142.408, 45 CFR 162.406, 45 CFR 

162.408; Use: The National Provider 

Identifier Application and Update Form 

is used by health care providers to apply 

for NPIs and furnish updates to the 

information they supplied on their 

initial applications. The form is also 

used to deactivate their NPIs if 

necessary. The original application form 

was approved in February 2005 and has 

been in use since May 23, 2005. The 

form is available on paper or can be 

completed via a web-based process. 

Health care providers can mail a paper 

application, complete the application 

via the web-based process via the 

National Plan and Provider 

Enumeration System (NPPES), or have a 

trusted organization submit the 

application on their behalf via the 

Electronic File Interchange (EFI) 

process. The Enumerator uses the 

NPPES to process the application and 

generate the NPI. NPPES is the Medicare 

contractor tasked with issuing NPIs, and 

maintaining and storing NPI data. Form 

Number: CMS–10114 (OMB control 

number: 0938–0931); Frequency: On 

occasion; Affected Public: Business or 

other for-profit, Not-for-profit 

institutions, and Federal government; 

Number of Respondents: 1,473,185; 

Total Annual Responses: 1,473,185; 

Total Annual Hours: 250,442. (For 

policy questions regarding this 

collection contact Kimberly McPhillips 

at 410–786–5374). 

2. Type of Information Collection 

Request: Reinstatement without change 

of a previously approved collection; 

Title of Information Collection: Hospice 

Request for Certification and Supporting 

Regulations; Use: The Hospice Request 

for Certification Form is the 

identification and screening form used 

to initiate the certification process and 

to determine if the provider has 

sufficient personnel to participate in the 

Medicare program. Form Number: 

CMS–417 (OMB Control number: 0938– 

0313); Frequency: Annually; Affected 

Public: Private Sector—Business or 

other for-profits; Number of 

Respondents: 851; Total Annual 

Responses: 851; Total Annual Hours: 

213. (For policy questions regarding this 

collection contact Thomas Pryor at 410– 

786–1332.) 

Dated: October 23, 2017. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2017–23341 Filed 10–25–17; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–N–1486] 

Authorizations of Emergency Use of In 

Vitro Diagnostic Devices for Detection 

of Zika Virus; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of two Emergency Use 

Authorizations (EUAs) (the 

Authorizations) for in vitro diagnostic 

devices for detection of the Zika virus 

in response to the Zika virus outbreak 

in the Americas. FDA issued these 

Authorizations under the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act), 

as requested by Thermo Fisher 

Scientific and The Center for Infection 

and Immunity, Columbia University. 

The Authorizations contain, among 

other things, conditions on the 

emergency use of the authorized in vitro 

diagnostic devices. The Authorizations 

follow the February 26, 2016, 

determination by the Secretary of Health 

and Human Services (HHS) that there is 

a significant potential for a public 

health emergency that has a significant 

potential to affect national security or 

the health and security of U.S. citizens 

living abroad and that involves Zika 

virus. On the basis of such 

determination, the Secretary of HHS 

declared on February 26, 2016, that 

circumstances exist justifying the 

authorization of emergency use of in 

vitro diagnostic tests for detection of 

Zika virus and/or diagnosis of Zika 

virus infection, subject to the terms of 

any authorization issued under the 

FD&C Act. The Authorizations, which 

include an explanation of the reasons 

for issuance, are reprinted in this 

document. 

DATES: The Authorization for Thermo 

Fisher Scientific is applicable as of 

August 2, 2017; the Authorization for 

The Center for Infection and Immunity, 

Columbia University is effective as of 

August 11, 2017. 

ADDRESSES: Submit written requests for 

single copies of the EUAs to the Office 

of Counterterrorism and Emerging 

Threats, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 1, 

Rm. 4338, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your request or include a fax number to 

which the Authorizations may be sent. 

See the SUPPLEMENTARY INFORMATION

section for electronic access to the 

Authorizations. 

FOR FURTHER INFORMATION CONTACT: 

Carmen Maher, Office of 

Counterterrorism and Emerging Threats, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 1, Rm. 

4347, Silver Spring, MD 20993–0002, 

301–796–8510 (this is not a toll free 

number). 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 564 of the FD&C Act (21 

U.S.C. 360bbb–3) as amended by the 

Project BioShield Act of 2004 (Pub. L. 

108–276) and the Pandemic and AllHazards Preparedness Reauthorization 

Act of 2013 (Pub. L. 113–5) allows FDA 

to strengthen the public health 

protections against biological, chemical, 

nuclear, and radiological agents. Among 

other things, section 564 of the FD&C 

Act allows FDA to authorize the use of 

an unapproved medical product or an 

unapproved use of an approved medical 

product in certain situations. With this 

EUA authority, FDA can help assure 

that medical countermeasures may be 

used in emergencies to diagnose, treat, 

or prevent serious or life-threatening 

diseases or conditions caused by 

biological, chemical, nuclear, or 

radiological agents when there are no 

adequate, approved, and available 

alternatives. 

Section 564(b)(1) of the FD&C Act 

provides that, before an EUA may be 

issued, the Secretary of HHS must 

declare that circumstances exist 

justifying the authorization based on 

one of the following grounds: (1) A 

determination by the Secretary of 

Homeland Security that there is a 

domestic emergency, or a significant 

potential for a domestic emergency, 

involving a heightened risk of attack 

with a biological, chemical, radiological, 

or nuclear agent or agents; (2) a 

determination by the Secretary of 

Defense that there is a military 

emergency, or a significant potential for 

a military emergency, involving a 

heightened risk to U.S. military forces of 

attack with a biological, chemical, 

radiological, or nuclear agent or agents; 

(3) a determination by the Secretary of 

HHS that there is a public health 

emergency, or a significant potential for 


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Federal Register / Vol. 82, No. 206 / Thursday, October 26, 2017 / Notices 49613 

1The Secretary of HHS has delegated the 

authority to issue an EUA under section 564 of the 

FD&C Act to the Commissioner of Food and Drugs. 

a public health emergency, that affects, 

or has a significant potential to affect, 

national security or the health and 

security of U.S. citizens living abroad, 

and that involves a biological, chemical, 

radiological, or nuclear agent or agents, 

or a disease or condition that may be 

attributable to such agent or agents; or 

(4) the identification of a material threat 

by the Secretary of Homeland Security 

under section 319F–2 of the Public 

Health Service (PHS) Act (42 U.S.C. 

247d–6b) sufficient to affect national 

security or the health and security of 

U.S. citizens living abroad. 

Once the Secretary of HHS has 

declared that circumstances exist 

justifying an authorization under 

section 564 of the FD&C Act, FDA may 

authorize the emergency use of a drug, 

device, or biological product if the 

Agency concludes that the statutory 

criteria are satisfied. Under section 

564(h)(1) of the FD&C Act, FDA is 

required to publish in the Federal 

Register a notice of each authorization, 

and each termination or revocation of an 

authorization, and an explanation of the 

reasons for the action. Section 564 of the 

FD&C Act permits FDA to authorize the 

introduction into interstate commerce of 

a drug, device, or biological product 

intended for use when the Secretary of 

HHS has declared that circumstances 

exist justifying the authorization of 

emergency use. Products appropriate for 

emergency use may include products 

and uses that are not approved, cleared, 

or licensed under sections 505, 510(k), 

or 515 of the FD&C Act (21 U.S.C. 355, 

360(k), and 360(e) or section 351 of the 

PHS Act (42 U.S.C. 262). FDA may issue 

an EUA only if, after consultation with 

the HHS Assistant Secretary for 

Preparedness and Response, the 

Director of the National Institutes of 

Health, and the Director of the Centers 

for Disease Control and Prevention (to 

the extent feasible and appropriate 

given the applicable circumstances), 

FDA 1 concludes: (1) That an agent 

referred to in a declaration of emergency 

or threat can cause a serious or lifethreatening disease or condition; (2) 

that, based on the totality of scientific 

evidence available to FDA, including 

data from adequate and well-controlled 

clinical trials, if available, it is 

reasonable to believe that: (A) The 

product may be effective in diagnosing, 

treating, or preventing (i) such disease 

or condition; or (ii) a serious or lifethreatening disease or condition caused 

by a product authorized under section 

564, approved or cleared under the 

FD&C Act, or licensed under section 351 

of the PHS Act, for diagnosing, treating, 

or preventing such a disease or 

condition caused by such an agent; and 

(B) the known and potential benefits of 

the product, when used to diagnose, 

prevent, or treat such disease or 

condition, outweigh the known and 

potential risks of the product, taking 

into consideration the material threat 

posed by the agent or agents identified 

in a declaration under section 

564(b)(1)(D) of the FD&C Act, if 

applicable; (3) that there is no adequate, 

approved, and available alternative to 

the product for diagnosing, preventing, 

or treating such disease or condition; 

and (4) that such other criteria as may 

be prescribed by regulation are satisfied. 

No other criteria for issuance have 

been prescribed by regulation under 

section 564(c)(4) of the FD&C Act. 

Because the statute is self-executing, 

regulations or guidance are not required 

for FDA to implement the EUA 

authority. 

II. EUA Requests for In Vitro Diagnostic 

Devices for Detection of the Zika Virus 

On February 26, 2016, the Secretary of 

HHS determined that there is a 

significant potential for a public health 

emergency that has a significant 

potential to affect national security or 

the health and security of U.S. citizens 

living abroad and that involves Zika 

virus. On February 26, 2016, under 

section 564(b)(1) of the FD&C Act, and 

on the basis of such determination, the 

Secretary of HHS declared that 

circumstances exist justifying the 

authorization of emergency use of in 

vitro diagnostic tests for detection of 

Zika virus and/or diagnosis of Zika 

virus infection, subject to the terms of 

any authorization issued under section 

564 of the FD&C Act. Notice of the 

determination and declaration of the 

Secretary was published in the Federal 

Register on March 2, 2016 (81 FR 

10878). On June 5, 2017, Thermo Fisher 

Scientific requested, and on August 2, 

2017, FDA issued, an EUA for the 

TaqPath Zika Virus Kit (ZIKV), subject 

to the terms of the Authorization. On 

July 31, 2017, The Center for Infection 

and Immunity, Columbia University 

requested, and on August 11, 2017, FDA 

issued, an EUA for the CII-ArboViroPlex 

rRT-PCR assay, subject to the terms of 

the Authorization. 

III. Electronic Access 

An electronic version of this 

document and the full text of the 

Authorizations are available on the 

internet at https://www.regulations.gov. 

IV. The Authorizations 

Having concluded that the criteria for 

issuance of the Authorizations under 

section 564(c) of the FD&C Act are met, 

FDA has authorized the emergency use 

of two in vitro diagnostic devices for 

detection of Zika virus subject to the 

terms of the Authorizations. The 

Authorizations in their entirety (not 

including the authorized versions of the 

fact sheets and other written materials) 

follows and provides an explanation of 

the reasons for issuance, as required by 

section 564(h)(1) of the FD&C Act. 

BILLING CODE 4164–01–P 


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1ssua1~ce of Authorization 

L 

of Authorization 
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• 
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Ill. 

Conditions of Authorization 

of the the 

Thenno 
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Promotion 

• 
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Page 2- Dr. W. Ian Lipkin, The Center for Infection and Immunity, Columbia University 

of such determination, the Secretary of HHS then declared that circumstances exist justifYing 

the authorization of the emergency use of in vitro diagnostic tests for detection of Zika virus 

and/or diagnosis of Zika virus infection, subject to the terms of any authorization issued under 

21 U.S.C. § 360bbb-3(a).4 

Having concluded that the criteria for issuance of this authorization under section 564( c) of the 

Act (21 U.S.C. § 360bbb-3(c)) are met, I am authorizing the emergency use of the CIIArboViroPlex rRT-PCR assay (as described in the Scope of Authorization section ofthis letter 

{Section II)) in individuals meeting CDC Zika virus clinical criteria (e.g., clinical and 

symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria 

{e.g., history of residence in or travel to a geographic region with active Zika transmission at the 

time of travel, or other epidemiological criteria for which Zika virus testing may be indicated) 

{as described in the Scope of Authorization section ofthis letter (Section II)) for the detection of 

Zika virus infection by authorized laboratories, subject to the terms of this authorization. 

I. Criteria for Issuance of Authorization 

I have concluded that the emergency use of the Cli-ArboViroPlex rRT-PCR assay for the 

detection of Zika virus and diagnosis of Zika virus infection in the specified population meets 

the criteria for issuance of an authorization under section 564(c) of the Act, because I have 

concluded that: 

l. The Zika virus can cause Zika virus infection, a serious or life-threatening disease or 

condition to humans infected with the virus; 

2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe 

that the CII-ArboViroPlex rRT-PCR assay, when used with the specified instrument(s) 

and in accordance with the Scope of Authorization, may be effective in detecting Zika 

virus and diagnosing Zika virus infection, and that the known and potential benefits of 

the CII-ArboViroPlex rRT-PCR assay for detecting Zika virus and diagnosing Zika 

virus infection outweigh the known and potential risks of such product; and 

3. There is no adequate, approved, and available alternative to the emergency use of the 

CII-Arbo ViroPlex rRT -PCR assay for detecting Zika virus and diagnosing Zika virus 

infection. s 

II. Seope of Authorization 

I have concluded, pursuant to section 564( d)(l) of the Act, that the scope of this authorization is 

limited to the use of the authorized CH-ArboViroPlex rRT-PCR assay by authorized laboratories 

for the qualitative detection and differentiation of RNA from Zika virus, dengue virus, 

564(b ){I )(C) of lhe Act, the Secretary may make a determination of a public health emergency, or of a significant 

f?tential for a public health emergency. 

HHS. Determination and Declaration Regarding Emergency Use of in Vitro Diagnostic Tests far Detection afZika 

Virus and/or DiagnosisofZika Virus Infection. 81 Fed. Reg. 10878 (Maroh2, 2016). 5 No other criteria of issuance have been prescribed by regulation under section .564(c )( 4) of the Act. 
Federal Register / Vol. 82, No. 206 / Thursday, October 26, 2017 / Notices 49625 


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Page 3- Dr. W. Ian Lipkin, The Center for Infection and Immunity, Colwnbia University 

chikungunya virus, and West Nile virus in serwn, and for the qualitative detection of Zika virus 

RNA in urine (collected alongside a patient-matched serwn specimen) in individuals meeting 

CDC Zika virus clinical criteria (e.g., clinical and symptoms associated with Zika virus 

infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel 

to a geographic region with active Zika transmission at the time of travel, or other 

epidemiological criteria for which Zika virus testing may be indicated). 

The Authorized CII-ArboViroPiex rRT-PCR assay 

The CII-ArboViroPlex rRT-PCR assay is a multiplex one-step real-time reverse transcription 

polymerase chain reaction (rRT-PCR) assay for the qualitative detection and differentiation of 

RNA from Zika virus, dengue virus, chikungunya virus, and West Nile virus in serum, and other 

authorized specimen types. The CII-ArboViroPiex rRT-PCR assay can also be used for the 

qualitative detection of Zika virus RNA in urine when collected alongside a patient-matched 

serum specimen and other authorized whole blood derived specimen types. 

To perfonn the CII-ArboViroPlex rRT-PCR assay, the RNA is first extracted and purified from 

the patient specimen. The RNA is then reverse transcribed into eDNA which is amplified using 

the primer set and detected using the specific probe. The rRT-PCR is performed on the CFX96 

Real-Time PCR Detection System (Bio-Rad), or other authorized instruments. 

The CII-ArboViroPlex rRT-PCR assay includes the following materials or other authorized 

materials: 

• ZIKV-MIX, DENV-MIX, CHIKV-MIX, WNV-MIX and RP-MIX vials containing 

primers and probes for the assay targets and internal contrul 

• ZPC, DPC, CP, WPC, HSC, eHSC, NTC vials containing the positive and negative 

controls used in the assay 

• Diluent vial used to reconstitute dried vials 

The CII-ArboViroPlex rRT-PCR assay also requires the use of additional materials and ancillary 

reagents that are not included with the test but are commonly used in clinical laboratories and are 

described in the authorized CII-ArboViroPlex rRT-PCR assay Instructions for Use. 

The CII-ArboViroPiex rRT-PCR assay requires the following contrul materials, or other 

authorized control materials; all controls listed below must generate expected results in order for 

a test to be considered valid, as outlined in the CII-ArboViroPlex rRT-PCR assay Instructions for 

Use: 

• Human Specimen Control: A hwnan cell culture preparation used as an extraction 

control and positive control for the RNase P primer and probe set that is extracted 

and tested concurrently with the test specimens. 

• Extracted Hwnan Specimen Control (eHSC): Extracted total nucleic acid from a 

hwnan cell culture preparation known to contain RNase P (eHSC), but negative for 

viral targets, is used as a control for perfonnance ofRNase P primer/probe set and 

PCR reagent function. 

• Positive Controls for viruses: Run with each batch of patient specimens. Monitors 

for failures ofrRT-PCR reagents and reaction conditions. 

o ZIKV Positive Control (ZPC), synthetic in vitro transcribed RNA 
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II 

.. 

.. 
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Page 5- Dr. W. Ian Lipkin, The Center for Infection and Immunity, Columbia University 

Arbo ViroPlex rRT-PCR assay, when used for detection of Zika virus and to diagnose Zika virus 

infection in the specified population (as described in the Scope of Authorization of this letter 

(Section II)}, meets the criteria set forth in section 564(c) of the Act concerning safety and 

potential effectiveness. 

The emergency use of the authorized CII-ArboViroPlex rRT-PCR assay under this EUA must be 

consistent with, and may not exceed, the terms of this letter, including the Scope of 

Authorization (Section II) and the Conditions of Authorization (Section IV). Subject to the 

terms of this EUA and under the circumstances set forth in the Secretary of HHS's determination 

described above and the Secretary of HHS' s corresponding declaration under section 564(b )(1 ), 

the CII-ArboViroPlex rRT-PCR assay described above is authorized to detect Zika virus and 

diagnose Zika virus infection in individuals meeting CDC Zika virus clinical criteria (e.g,., 

clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus 

epidemiological criteria (e.g., history of residence in or travel to a geographic region with active 

Zika virus transmissions at the time of travel, or other epidemiological criteria for which Zika 

virus testing may be indicated). 

This EUA will cease to be effective when the HHS declaration that circumstances exist to justizy 

the EUA is terminated under section 564(b)(2) of the Act or when the EUA is revoked under 

section 564(g) of the Act. 

10. Waiver of Certain Requirements 

I am waiving the following requirements for the CII-ArboViroPlex rRT-PCR assay during the 

duration of this EUA: 

• Current good manufacturing practice requirements, including the quality system 

requirements under 21 CFR Part 820 with respect to the design, manufacture, 

packaging, labeling, storage, and distribution oftheCII-ArboViroPlex rRT-PCR 

assay. 

• Labeling requirements for cleared, approved, or investigational devices, including 

labeling requirements under21 CFR 809.10 and 21 CFR 809.30, except for the 

intended use statement (21 CFR 809.10(a)(2), (b)(2)); adequate directions for use 

(21 U.S.C. 352(:1)), (21 CFR 809JO(b)(5), (7), and (8)}; any appropriate limitations 

on the use of the device including information required under 21 CFR 809.1 O(a)(4); 

and any available information regarding performance of the device, including 

requirements under 21 CFR 809.10(b)(12). 

IV. Conditions of Authorization 

Pursuant to section 564 of the Act, I am establishing the following conditions on this 

authorization: 
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Columbia 

Columbia 
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Page 7 Dr. W. Ian Lipkin, The Center for Infection and Immunity, Columbia University 

Arbo ViroPlex rRT -PCR assay, including the name, address, and phone number of any 

authorized distributor( s ). 

J. Columbia University will provide its authorized distributor(s) with a copy of this 

and communicate to its authorized distributor(s) any subsequent amendments 

that might be made to this EUA and its authorized accompanying materials (e.g., Fact 

Sheets, Instructions for Use). 

K. Columbia University may request changes to the authorized CII-Arbo ViroPlex rRT ~ 

PCR assay Fact Sheet for Healthcare Providers and the authorized CII-ArboViroPlex 

rRT-PCR assay Fact Sheet for Patients. Such requests will be made by Columbia 

University in consultation with, and require concurrence of, DMD/OIRJCDRH. 

L. Columbia University may request the addition of other instruments for use with the 

authorized CII-ArboViroPlex rRT-PCR assay. Such requests will be made Columbia 

University in consultation with, and require concurrence of, DMD/OIRICDRH. 

M. Columbia University may request the addition of other extraction methods for use with 

the authorized CII-ArboViroPlex rRT-PCR assay. Such requests will be made by 

Columbia University in consultation with, and require concurrence of, DMD/OIR/CDRH. 

N. Columbia University may request the addition of other specimen types for use with the 

authorized CII·ArboViroPiex rRT-PCR assay. Such requests will be made by 

Columbia University in consultation with, and require concurrence of, 

DMD/OIRJCDRH. 

0. Columbia University may request the addition and/or substitution of other control 

materials for use with the authorized CII-Arbo ViroPlex. rRT-PCR assay. Such requests 

will be made by Columbia University in consultation with, and require concurrence of, 

DMD/OIRJCDRH. 

P. Columbia University may request the addition and/or substitution of other ancillary 

reagents and materials for use with the authorized CII-Arbo ViroPlex rRT -PCR assay. 

Such requests will be made by Columbia University in consultation with, and require 

concurrence of, DMD/OIRJCDRH. 

Q. Columbia University will assess traceability7 of the CII-ArboViroPlex rRT-PCR assay 

with FDA-recommended reference material(s). After submission to FDA and 

DMD/OIRICDRH's review of and concurrence with the data, Columbia University will 

update its labeling to reflect the additional testing. 

R. Columbia University will track adverse events and 

803. 

Authorized Laboratories 

to FDA under 21 CFR Part 

1 Traceability refers to tracing analytical sensitivity/reactivity back to a FDA-recommended reference material. 
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Columbia and Authorized 

Conditions 
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9- Dr. W. Ian Lipkin, The Center for Infection and Immunity, Columbia University 

authorized CII-ArboViroPlex rRT-PCR assay shall be consistent with the Fact Sheets 

and authorized labeling, !IS well as the terms set forth in this EUA and the 11pplicable 

requirements set forth in the Act and FDA regulations. 

CC. All advertising and promotional descriptive printed matter relating to the use of the 

authorized CII-ArboViroPlex rRT-PCR assay shall clearly and conspicuously state that: 

• This test has not been FDA cleared or approved; 

• This test has been authorized by FDA under an EUA for use by authorized 

laboratories; 

• This test has been authorized only for the detection and differentiation of RNA 

:from Zika virus, dengue virus, chik:ungunya virus, and West Nile virus, not for 

any other viruses or pathogens; and 

• This test is only authorized for the duration of the declaration that circumstances 

exist justifying the authorization of the emergency use of in vitro diagnostic tests 

fur detection of Zika virus and/or diagnosis of Zika virus infection under section 

564(b)(I) of the Act, 21 U.S.C. § 360bbb-3(b)(l), unless the authorization is 

terminated or revoked sooner. 

No advertising or promotional descriptive printed matter relating to the nse of the authorized 

CII • Arbo ViroPlex rRT -PCR assay may represent or suggest that this test is safe or effective for 

the diagnosis ofZika virus infection. 

The emergency use of the authorized CII-Arbo ViroPiex rRT -PCR assay as described in this 

letter of authorization must comply with the conditions and all other terms of this 

authorization. 

V. Duration of Authorization 

This EUA will be effective until the declaration that circumstances exist justifying the 

authorization of the emergency use of in vitro diagnostic tests fur detection of Zika virus and/or 

diagnosis of Zika virus infection is terminated under section 564(b )(2) of the Act or the EUA is 

revoked under section 564(g) of the Act. 

Sincerely, 

Enclosures 
49632 Federal Register / Vol. 82, No. 206 / Thursday, October 26, 2017 / Notices 

Dated: October 20, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–23224 Filed 10–25–17; 8:45 am] 

BILLING CODE 4164–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–5818] 

Pharmacy Compounding Advisory 

Committee; Notice of Meeting; 

Establishment of a Public Docket; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Pharmacy Compounding 

Advisory Committee (PCAC). The 

general function of the committee is to 

provide advice on scientific, technical, 

and medical issues concerning drug 

compounding under the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act), 

and, as required, any other product for 

which FDA has regulatory 

responsibility, and to make appropriate 

recommendations to the Agency. The 

meeting will be open to the public. 

DATES: The meeting will be held on 

November 20, 2017, from 8:30 a.m. to 5 

p.m. and November 21, 2017, from 8:30 

a.m. to 11:30 a.m. 

ADDRESSES: FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503), Silver Spring, MD 20993–0002. 

Answers to commonly asked questions, 

including information regarding special 

accommodations due to a disability, 

visitor parking, and transportation may 

be accessed at: https://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm408555.htm. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2017–N–5818. 

The docket will close on November 17, 

2017. Submit either electronic or 

written comments on this public 

meeting by November 17, 2017. Please 

note that late, untimely filed comments 

will not be considered. Electronic 

comments must be submitted on or 

before November 17, 2017. The https:// 

www.regulations.gov electronic filing 

system will accept comments until 

midnight Eastern Time at the end of 

November 17, 2017. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

Comments received on or before 

November 3, 2017, will be provided to 

the committee. Comments received after 

that date will be taken into 

consideration by the Agency. 

You may submit comments as 

follows: 

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, 

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): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, 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– 

2017–N–5818 for ‘‘Pharmacy 

Compounding Advisory Committee; 

Notice of Meeting; Establishment of a 

Public Docket; Request for Comments.’’ 

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 

Dockets Management Staff 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 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. 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.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

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 Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Cindy Chee, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 31, Rm. 2417, Silver Spring, 

MD 20993–0002, 301–796–9001, Fax: 

301–847–8533, email: PCAC@

fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 


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