81_FR_14915 81 FR 14862 - Wesley A. McQuerry: Debarment Order

81 FR 14862 - Wesley A. McQuerry: Debarment Order

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 53 (March 18, 2016)

Page Range14862-14863
FR Document2016-06104

The U.S. Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Wesley A. McQuerry from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. McQuerry was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of a drug product and otherwise relating to the regulation of a drug product under the FD&C Act. Mr. McQuerry was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Mr. McQuerry failed to respond. Mr. McQuerry's failure to respond constitutes a waiver of his right to a hearing concerning this action.

Federal Register, Volume 81 Issue 53 (Friday, March 18, 2016)
[Federal Register Volume 81, Number 53 (Friday, March 18, 2016)]
[Notices]
[Pages 14862-14863]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-06104]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3225]


Wesley A. McQuerry: Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The U.S. Food and Drug Administration (FDA or Agency) is 
issuing an order under the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) permanently debarring Wesley A. McQuerry from providing 
services in any capacity to a person that has an approved or pending 
drug product application. FDA bases this order on a finding that Mr. 
McQuerry was convicted of a felony under Federal law for conduct 
relating to the development or approval, including the process for 
development or approval, of a drug product and otherwise relating to 
the regulation of a drug product under the FD&C Act. Mr. McQuerry was 
given notice of the proposed permanent debarment and an opportunity to 
request a hearing within the timeframe prescribed by regulation. Mr. 
McQuerry failed to respond. Mr. McQuerry's failure to respond 
constitutes a waiver of his right to a hearing concerning this action.

DATES: This order is effective March 18, 2016.

ADDRESSES: Submit applications for special termination of debarment to 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kenny Shade, (ELEM-4144), Division of 
Enforcement, Office of Enforcement and Import Operations, Office of 
Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr., 
Rockville, MD 20857, 301-796-4640.

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 306(a)(2)(A) of the FD&C Act (21 U.S.C. 335a(a)(2)(A)) 
requires debarment of an individual if FDA finds that the individual 
has been convicted of a felony under Federal law for conduct relating 
to the development or approval, including the process for development 
or approval, of any drug product. Section 306(a)(2)(B) of the FD&C Act 
requires debarment of an individual if FDA finds that the individual 
has been convicted of a felony under Federal law for conduct otherwise 
relating to the regulation of any drug product under the FD&C Act. On 
February 10, 2015, the U.S. District Court for the Northern District of 
Illinois entered judgment against Mr. McQuerry for one count of 
falsifying a material fact, in violation of 18 U.S.C. 1001(a)(1).
    The factual basis for this conviction is as follows: Mr. McQuerry 
was the study coordinator for a drug clinical trial at an institution 
in the Northern District of Illinois. The clinical trial occurred under 
the authority of FDA, and clinical trial data was required to be 
submitted to FDA before the drug could be approved for sale in the 
United States.
    As study coordinator, Mr. McQuerry's responsibilities for 
administering the clinical trial included, among other things, 
coordinating patient visits, maintaining patient files, ensuring that 
administrative procedures were followed regarding the collection of 
patient data, disbursing American Express gift checks to trial 
participants, and transmitting clinical trial data from the institution 
to the administrator, which was administering the clinical trial on 
behalf of the pharmaceutical company. Mr. McQuerry knew that the 
results of the clinical trial would be reported to FDA, and he knew it 
was unlawful to provide false information to the pharmaceutical 
company.
    Beginning no later than January 2008, and continuing through at 
least October 2008, in the Northern District of Illinois, Mr. McQuerry 
knowingly and willfully falsified, concealed, and covered up by trick, 
scheme, and device material facts in a matter within the jurisdiction 
of FDA, namely that at least four patients and others were 
participating in the drug clinical trial, when in fact these patients 
did not participate in that clinical trial. Specifically, between 
January and October 2008, Mr. McQuerry created fifteen to twenty 
fictional patients, whom he claimed were participants in the clinical 
trial. Mr. McQuerry falsified signatures of those patients on consent 
forms and falsified doctors' signatures on medical evaluations for 
those patients. He provided his own blood, stool, and EKG results, 
which he claimed were provided by the fictional patients. He also 
transmitted false data and information to the administrator regarding 
these fictional patients and made and caused to be made false 
statements regarding their participation in the study and attendance at 
office visits, all of which he knew would be provided to the 
pharmaceutical company and to FDA.
    Mr. McQuerry made false statements to the administrator about the 
whereabouts of the fictitious trial participants. In particular, on 
August 28, 2008, he provided false and fraudulent statements to the 
administrator regarding the attendance of two patients at study visits, 
knowing that the two patients were not in fact enrolled in the study 
and did not attend a single study visit.
    As study coordinator, Mr. McQuerry was responsible for disbursing 
gift checks, which were provided by the pharmaceutical company to 
patients at various points during the patients' participation in the 
clinical trial. Mr. McQuerry falsely and fraudulently claimed to have 
disbursed gift checks when, in fact, no checks were disbursed

[[Page 14863]]

to patients. Instead, between approximately July 11, 2008 and September 
3, 2008, Mr. McQuerry deposited over $2,300 of gift checks into his 
personal bank account. He additionally used the gift checks to make 
direct purchases at various retailers. Mr. McQuerry's fraud resulted in 
a loss of approximately $200,098 to the pharmaceutical company.
    As a result of this conviction, FDA sent Mr. McQuerry by certified 
mail on October 30, 2015, a notice proposing to permanently debar him 
from providing services in any capacity to a person that has an 
approved or pending drug product application. The proposal was based on 
a finding, under section 306(a)(2)(A) and (a)(2)(B) of the FD&C Act, 
that Mr. McQuerry was convicted of a felony under Federal law for 
conduct relating to the development or approval, including the process 
for development or approval, of a drug product, and conduct otherwise 
relating to the regulation of a drug product under the FD&C Act. The 
proposal also offered Mr. McQuerry an opportunity to request a hearing, 
providing him 30 days from the date of receipt of the letter in which 
to file the request, and advised him that failure to request a hearing 
constituted a waiver of the opportunity for a hearing and of any 
contentions concerning this action. Mr. McQuerry did not request a 
hearing and has, therefore, waived his opportunity for a hearing and 
any contentions concerning his debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Director, Office of Enforcement and Import 
Operations, Office of Regulatory Affairs, under sections 306(a)(2)(A) 
and (a)(2)(B) of the FD&C Act, under authority delegated to him (Staff 
Manual Guide 1410.35), finds that Wesley A. McQuerry has been convicted 
of a felony under Federal law for conduct relating to the development 
or approval, including the process for development or approval, of a 
drug product and conduct otherwise relating to the regulation of a drug 
product under the FD&C Act.
    As a result of the foregoing finding, Wesley A. McQuerry is 
permanently debarred from providing services in any capacity to a 
person with an approved or pending drug product application under 
sections 505, 512, or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 
382), or under section 351 of the Public Health Service Act (42 U.S.C. 
262), effective (see DATES) (see section 201(dd), 306(c)(1)(B), and 
306(c)(2)(A)(ii) of the FD&C Act, (21 U.S.C. 321(dd), 335a(c)(1)(B), 
and 335a(c)(2)(A)(ii)). Any person with an approved or pending drug 
product application who knowingly employs or retains as a consultant or 
contractor, or otherwise uses the services of Wesley A. McQuerry, in 
any capacity during his debarment, will be subject to civil money 
penalties (section 307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))). 
If Mr. McQuerry provides services in any capacity to a person with an 
approved or pending drug product application during his period of 
debarment, he will be subject to civil money penalties (section 
307(a)(7) of the FD&C Act). In addition, FDA will not accept or review 
any abbreviated new drug applications from Wesley A. McQuerry during 
his period of debarment (section 306(c)(1)(B) of the FD&C Act.
    Any application by Mr. McQuerry for special termination of 
debarment under section 306(d)(4) of the FD&C Act should be identified 
with Docket No. FDA-2015-N-3225 and sent to the Division of Dockets 
Management (see ADDRESSES). All such submissions are to be filed in 
four copies. The public availability of information in these 
submissions is governed by 21 CFR 10.20.
    Publicly available submissions may be seen in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: March 11, 2016.
Armando Zamora,
Deputy Director, Office of Enforcement and Import Operations, Office of 
Regulatory Affairs.
[FR Doc. 2016-06104 Filed 3-17-16; 8:45 am]
BILLING CODE 4164-01-P



                                                    14862                                      Federal Register / Vol. 81, No. 53 / Friday, March 18, 2016 / Notices

                                                                                                         TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN—(CBER) 1
                                                                                                                                                                              Number of                                                Average
                                                                                                                                                   Number of                                            Total annual
                                                                                    21 CFR section                                                                          responses per                                            burden per              Total hours
                                                                                                                                                  respondents                                            responses
                                                                                                                                                                              respondent                                              response

                                                    320.31(d) Bioavailability and Bioequivalence Safety Re-
                                                      ports ..................................................................................                      1                            1                         1                         14                14
                                                    312.32(c)(1)(ii) and (c)(1)(iii) IND Safety Reports ...............                                           137                            4                       548                         12             6,576
                                                    312.32(c)(1)(iv) IND Safety Reports ....................................                                        5                          1.4                         7                         12                84

                                                          Total (CBER) ................................................................          ........................   ........................   ........................   ........................          6,674
                                                       1 There     are no capital costs or operating and maintenance costs associated with this collection of information.


                                                      Dated: March 14, 2016.                                                   Enforcement, Office of Enforcement and                                      unlawful to provide false information to
                                                    Leslie Kux,                                                                Import Operations, Office of Regulatory                                     the pharmaceutical company.
                                                    Associate Commissioner for Policy.                                         Affairs, Food and Drug Administration,                                         Beginning no later than January 2008,
                                                    [FR Doc. 2016–06128 Filed 3–17–16; 8:45 am]                                12420 Parklawn Dr., Rockville, MD                                           and continuing through at least October
                                                    BILLING CODE 4164–01–P
                                                                                                                               20857, 301–796–4640.                                                        2008, in the Northern District of Illinois,
                                                                                                                               SUPPLEMENTARY INFORMATION:
                                                                                                                                                                                                           Mr. McQuerry knowingly and willfully
                                                                                                                                                                                                           falsified, concealed, and covered up by
                                                    DEPARTMENT OF HEALTH AND                                                   I. Background                                                               trick, scheme, and device material facts
                                                    HUMAN SERVICES                                                                                                                                         in a matter within the jurisdiction of
                                                                                                                                  Section 306(a)(2)(A) of the FD&C Act                                     FDA, namely that at least four patients
                                                    Food and Drug Administration                                               (21 U.S.C. 335a(a)(2)(A)) requires                                          and others were participating in the
                                                                                                                               debarment of an individual if FDA finds                                     drug clinical trial, when in fact these
                                                    [Docket No. FDA–2015–N–3225]                                               that the individual has been convicted                                      patients did not participate in that
                                                                                                                               of a felony under Federal law for                                           clinical trial. Specifically, between
                                                    Wesley A. McQuerry: Debarment Order
                                                                                                                               conduct relating to the development or                                      January and October 2008, Mr.
                                                    AGENCY:        Food and Drug Administration,                               approval, including the process for                                         McQuerry created fifteen to twenty
                                                    HHS.                                                                       development or approval, of any drug                                        fictional patients, whom he claimed
                                                    ACTION:      Notice.                                                       product. Section 306(a)(2)(B) of the                                        were participants in the clinical trial.
                                                                                                                               FD&C Act requires debarment of an                                           Mr. McQuerry falsified signatures of
                                                    SUMMARY:    The U.S. Food and Drug                                         individual if FDA finds that the                                            those patients on consent forms and
                                                    Administration (FDA or Agency) is                                          individual has been convicted of a                                          falsified doctors’ signatures on medical
                                                    issuing an order under the Federal                                         felony under Federal law for conduct                                        evaluations for those patients. He
                                                    Food, Drug, and Cosmetic Act (the                                          otherwise relating to the regulation of                                     provided his own blood, stool, and EKG
                                                    FD&C Act) permanently debarring                                            any drug product under the FD&C Act.                                        results, which he claimed were
                                                    Wesley A. McQuerry from providing                                          On February 10, 2015, the U.S. District                                     provided by the fictional patients. He
                                                    services in any capacity to a person that                                  Court for the Northern District of Illinois                                 also transmitted false data and
                                                    has an approved or pending drug                                            entered judgment against Mr. McQuerry                                       information to the administrator
                                                    product application. FDA bases this                                        for one count of falsifying a material                                      regarding these fictional patients and
                                                    order on a finding that Mr. McQuerry                                       fact, in violation of 18 U.S.C. 1001(a)(1).                                 made and caused to be made false
                                                    was convicted of a felony under Federal                                       The factual basis for this conviction is                                 statements regarding their participation
                                                    law for conduct relating to the                                            as follows: Mr. McQuerry was the study                                      in the study and attendance at office
                                                    development or approval, including the                                     coordinator for a drug clinical trial at an                                 visits, all of which he knew would be
                                                    process for development or approval, of                                    institution in the Northern District of                                     provided to the pharmaceutical
                                                    a drug product and otherwise relating to                                   Illinois. The clinical trial occurred                                       company and to FDA.
                                                    the regulation of a drug product under                                     under the authority of FDA, and clinical                                       Mr. McQuerry made false statements
                                                    the FD&C Act. Mr. McQuerry was given                                       trial data was required to be submitted                                     to the administrator about the
                                                    notice of the proposed permanent                                           to FDA before the drug could be                                             whereabouts of the fictitious trial
                                                    debarment and an opportunity to                                            approved for sale in the United States.                                     participants. In particular, on August
                                                    request a hearing within the timeframe
                                                                                                                                  As study coordinator, Mr. McQuerry’s                                     28, 2008, he provided false and
                                                    prescribed by regulation. Mr. McQuerry
                                                                                                                               responsibilities for administering the                                      fraudulent statements to the
                                                    failed to respond. Mr. McQuerry’s
                                                                                                                               clinical trial included, among other                                        administrator regarding the attendance
                                                    failure to respond constitutes a waiver
                                                                                                                               things, coordinating patient visits,                                        of two patients at study visits, knowing
                                                    of his right to a hearing concerning this
                                                                                                                               maintaining patient files, ensuring that                                    that the two patients were not in fact
                                                    action.
                                                                                                                               administrative procedures were                                              enrolled in the study and did not attend
                                                    DATES: This order is effective March 18,                                                                                                               a single study visit.
                                                                                                                               followed regarding the collection of
                                                    2016.                                                                      patient data, disbursing American                                              As study coordinator, Mr. McQuerry
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                    ADDRESSES: Submit applications for                                         Express gift checks to trial participants,                                  was responsible for disbursing gift
                                                    special termination of debarment to the                                    and transmitting clinical trial data from                                   checks, which were provided by the
                                                    Division of Dockets Management (HFA–                                       the institution to the administrator,                                       pharmaceutical company to patients at
                                                    305), Food and Drug Administration,                                        which was administering the clinical                                        various points during the patients’
                                                    5630 Fishers Lane, Rm. 1061, Rockville,                                    trial on behalf of the pharmaceutical                                       participation in the clinical trial. Mr.
                                                    MD 20852.                                                                  company. Mr. McQuerry knew that the                                         McQuerry falsely and fraudulently
                                                    FOR FURTHER INFORMATION CONTACT:                                           results of the clinical trial would be                                      claimed to have disbursed gift checks
                                                    Kenny Shade, (ELEM–4144), Division of                                      reported to FDA, and he knew it was                                         when, in fact, no checks were disbursed


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                                                                                    Federal Register / Vol. 81, No. 53 / Friday, March 18, 2016 / Notices                                                 14863

                                                    to patients. Instead, between                           approved or pending drug product                         Agenda: The Committee serves to advise
                                                    approximately July 11, 2008 and                         application who knowingly employs or                  and make recommendations to the Director,
                                                    September 3, 2008, Mr. McQuerry                         retains as a consultant or contractor, or             Office of Research on Women’s Health
                                                    deposited over $2,300 of gift checks into               otherwise uses the services of Wesley A.              (ORWH) on a broad range of topics.
                                                                                                                                                                  Information is also available on the
                                                    his personal bank account. He                           McQuerry, in any capacity during his                  Institute’s/Center’s home page: http://orwh.
                                                    additionally used the gift checks to                    debarment, will be subject to civil                   od.nih.gov/about/acrwh/index.asp where an
                                                    make direct purchases at various                        money penalties (section 307(a)(6) of the             agenda and any additional information for
                                                    retailers. Mr. McQuerry’s fraud resulted                FD&C Act (21 U.S.C. 335b(a)(6))). If Mr.              the meeting will be posted when available.
                                                    in a loss of approximately $200,098 to                  McQuerry provides services in any                        Place: National Institutes of Health,
                                                    the pharmaceutical company.                             capacity to a person with an approved                 Building 31, Room 6C, 31 Center Drive,
                                                      As a result of this conviction, FDA                   or pending drug product application                   Bethesda, MD 20892.
                                                    sent Mr. McQuerry by certified mail on                  during his period of debarment, he will                  Contact Person: Terri L. Cornelison, MD,
                                                    October 30, 2015, a notice proposing to                 be subject to civil money penalties                   Ph.D., Associate Director for Clinical
                                                    permanently debar him from providing                    (section 307(a)(7) of the FD&C Act). In               Research, Office of Research on Women’s
                                                    services in any capacity to a person that                                                                     Health, Office of the Director, 6707
                                                                                                            addition, FDA will not accept or review               Democracy Blvd., Bethesda, MD 20817, 301–
                                                    has an approved or pending drug                         any abbreviated new drug applications                 402–1770, cornelit@od.nih.gov.
                                                    product application. The proposal was                   from Wesley A. McQuerry during his
                                                    based on a finding, under section                                                                                Any interested person may file written
                                                                                                            period of debarment (section                          comments with the committee by forwarding
                                                    306(a)(2)(A) and (a)(2)(B) of the FD&C                  306(c)(1)(B) of the FD&C Act.                         the statement to the Contact Person listed on
                                                    Act, that Mr. McQuerry was convicted                       Any application by Mr. McQuerry for                this notice. The statement should include the
                                                    of a felony under Federal law for                       special termination of debarment under                name, address, telephone number and when
                                                    conduct relating to the development or                  section 306(d)(4) of the FD&C Act                     applicable, the business or professional
                                                    approval, including the process for                     should be identified with Docket No.                  affiliation of the interested person.
                                                    development or approval, of a drug                      FDA–2015–N–3225 and sent to the                          In the interest of security, NIH has
                                                    product, and conduct otherwise relating                 Division of Dockets Management (see                   instituted stringent procedures for entrance
                                                    to the regulation of a drug product                     ADDRESSES). All such submissions are to
                                                                                                                                                                  onto the NIH campus. All visitor vehicles,
                                                    under the FD&C Act. The proposal also                                                                         including taxicabs, hotel, and airport shuttles
                                                                                                            be filed in four copies. The public                   will be inspected before being allowed on
                                                    offered Mr. McQuerry an opportunity to                  availability of information in these                  campus. Visitors will be asked to show one
                                                    request a hearing, providing him 30                     submissions is governed by 21 CFR                     form of identification (for example, a
                                                    days from the date of receipt of the letter             10.20.                                                government-issued photo ID, driver’s license,
                                                    in which to file the request, and advised                 Publicly available submissions may                  or passport) and to state the purpose of their
                                                    him that failure to request a hearing                   be seen in the Division of Dockets                    visit.
                                                    constituted a waiver of the opportunity                 Management between 9 a.m. and 4 p.m.,                    Information is also available on the
                                                    for a hearing and of any contentions                    Monday through Friday.                                Institute’s/Center’s home page:
                                                    concerning this action. Mr. McQuerry                                                                          www4.ordh.od.nih.gov/, where an agenda
                                                                                                              Dated: March 11, 2016.                              and any additional information for the
                                                    did not request a hearing and has,
                                                    therefore, waived his opportunity for a                 Armando Zamora,                                       meeting will be posted when available.
                                                    hearing and any contentions concerning                  Deputy Director, Office of Enforcement and            (Catalogue of Federal Domestic Assistance
                                                    his debarment (21 CFR part 12).                         Import Operations, Office of Regulatory               Program Nos. 93.14, Intramural Research
                                                                                                            Affairs.                                              Training Award; 93.22, Clinical Research
                                                    II. Findings and Order                                  [FR Doc. 2016–06104 Filed 3–17–16; 8:45 am]           Loan Repayment Program for Individuals
                                                       Therefore, the Director, Office of                   BILLING CODE 4164–01–P                                from Disadvantaged Backgrounds; 93.232,
                                                    Enforcement and Import Operations,                                                                            Loan Repayment Program for Research
                                                                                                                                                                  Generally; 93.39, Academic Research
                                                    Office of Regulatory Affairs, under                                                                           Enhancement Award; 93.936, NIH Acquired
                                                    sections 306(a)(2)(A) and (a)(2)(B) of the              DEPARTMENT OF HEALTH AND
                                                                                                                                                                  Immunodeficiency Syndrome Research Loan
                                                    FD&C Act, under authority delegated to                  HUMAN SERVICES                                        Repayment Program; 93.187, Undergraduate
                                                    him (Staff Manual Guide 1410.35), finds                                                                       Scholarship Program for Individuals from
                                                    that Wesley A. McQuerry has been                        National Institutes of Health                         Disadvantaged Backgrounds, National
                                                    convicted of a felony under Federal law                                                                       Institutes of Health, HHS)
                                                                                                            Office of the Director, National
                                                    for conduct relating to the development                                                                         Dated: March 14, 2016.
                                                                                                            Institutes of Health; Notice of Meeting
                                                    or approval, including the process for                                                                        Carolyn Baum,
                                                    development or approval, of a drug                         Pursuant to section 10(a) of the
                                                                                                                                                                  Program Analyst, Office of Federal Advisory
                                                    product and conduct otherwise relating                  Federal Advisory Committee Act, as                    Committee Policy.
                                                    to the regulation of a drug product                     amended (5 U.S.C. App.), notice is
                                                                                                                                                                  [FR Doc. 2016–06075 Filed 3–17–16; 8:45 am]
                                                    under the FD&C Act.                                     hereby given of a meeting of the
                                                                                                                                                                  BILLING CODE 4140–01–P
                                                       As a result of the foregoing finding,                Advisory Committee on Research on
                                                    Wesley A. McQuerry is permanently                       Women’s Health.
                                                    debarred from providing services in any                    The meeting will be open to the
                                                                                                                                                                  DEPARTMENT OF HEALTH AND
                                                    capacity to a person with an approved                   public, with attendance limited to space
                                                                                                                                                                  HUMAN SERVICES
                                                    or pending drug product application                     available. Individuals who plan to
                                                    under sections 505, 512, or 802 of the                  attend and need special assistance, such
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                                                                                                                                  National Institutes of Health
                                                    FD&C Act (21 U.S.C. 355, 360b, or 382),                 as sign language interpretation or other
                                                    or under section 351 of the Public                      reasonable accommodations, should                     National Cancer Institute; Notice of
                                                    Health Service Act (42 U.S.C. 262),                     notify the Contact Person listed below                Closed Meetings
                                                    effective (see DATES) (see section                      in advance of the meeting.
                                                    201(dd), 306(c)(1)(B), and                                Name of Committee: Advisory Committee                 Pursuant to section 10(d) of the
                                                    306(c)(2)(A)(ii) of the FD&C Act, (21                   on Research on Women’s Health.                        Federal Advisory Committee Act, as
                                                    U.S.C. 321(dd), 335a(c)(1)(B), and                        Date: April 19, 2016.                               amended (5 U.S.C. App.), notice is
                                                    335a(c)(2)(A)(ii)). Any person with an                    Time: 9:00 a.m. to 4:00 p.m.                        hereby given of the following meetings.


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Document Created: 2018-02-02 15:13:55
Document Modified: 2018-02-02 15:13:55
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesThis order is effective March 18, 2016.
ContactKenny Shade, (ELEM-4144), Division of Enforcement, Office of Enforcement and Import Operations, Office of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857, 301-796-4640.
FR Citation81 FR 14862 

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