83 FR 48829 - Dilip Patel; Denial of Hearing; Final Debarment Order

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 188 (September 27, 2018)

Page Range		48829-48831
FR Document		2018-20977

The Food and Drug Administration (FDA or Agency) is denying a request for a hearing submitted by Dilip Patel and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Patel for 5 years 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 Patel was convicted of a conspiracy to commit a felony under Federal law for conduct relating to the regulation of a drug product under the FD&C Act and that the conduct underlying the conviction undermines the process for the regulation of drugs. In determining the appropriateness and period of Patel's debarment, FDA considered the relevant factors listed in the FD&C Act. Patel failed to file with the Agency information and analyses sufficient to create a basis for a hearing concerning this action.

Federal Register, Volume 83 Issue 188 (Thursday, September 27, 2018)

[Federal Register Volume 83, Number 188 (Thursday, September 27, 2018)]
[Notices]
[Pages 48829-48831]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-20977]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0329]

Dilip Patel; Denial of Hearing; Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is denying a
request for a hearing submitted by Dilip Patel and is issuing an order
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring
Patel for 5 years 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 Patel was convicted of a conspiracy to
commit a felony under Federal law for conduct relating to the
regulation of a drug product under the FD&C Act and that the conduct
underlying the conviction undermines the process for the regulation of
drugs. In determining the appropriateness and period of Patel's
debarment, FDA considered the relevant factors listed in the FD&C Act.
Patel failed to file with the Agency information and analyses
sufficient to create a basis for a hearing concerning this action.

DATES: The order is applicable September 27, 2018.

ADDRESSES: Any application for termination of debarment by Patel under
section 306(d) of the FD&C Act (application) may be submitted as
follows:

Electronic Submissions

Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. An application
submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because
your application will be made public, you are solely responsible for
ensuring that your application 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 application,
that information will be posted on https://www.regulations.gov.
If you want to submit an application with confidential
information that you do not wish to be made available to the public,
submit the application 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 a written/paper application submitted to the Dockets
Management Staff, FDA will post your application, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: Your application must include the Docket No. FDA-
2009-N-0329. An application will be placed in the docket and, unless
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 an application with
confidential information that you do not wish to be made publicly
available, submit your application 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 your application. 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 application 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.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket, 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 between 9 a.m. and 4 p.m., Monday through Friday. Publicly
available submissions may be seen in the docket.

FOR FURTHER INFORMATION CONTACT: Rachael Vieder Linowes, Office of
Scientific Integrity, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 4206, Silver Spring, MD 20993, 240-402-5931.

SUPPLEMENTARY INFORMATION:

I. Background

Section 306(b)(2)(B)(i)(II) of the FD&C Act (21 U.S.C.
335a(b)(2)(B)(i)(II)) permits FDA to debar an individual if it finds:
(1) That the individual has been convicted of a conspiracy to commit a
felony under Federal law for conduct relating to the regulation of any
drug product under the FD&C Act and (2) that the type of conduct which
served as the basis for the conviction undermines the process for the
regulation of drugs.
On April 24, 2007, Patel pled guilty to one count of conspiracy to
distribute misbranded and adulterated drugs, in violation of 18 U.S.C.
371. On December 9, 2010, the U.S. District Court for the District of
New Jersey entered the conviction, sentenced Patel to 2 years of
probation, and imposed a $3,000 fine. Patel's conviction stemmed from
his employment at Able Laboratories, Inc. (Able), where he was a
Supervisor of Analytical Control and later a Quality Control Manager in
the Quality Control Department. Patel and his co-conspirators conspired
and agreed with others to cause the introduction of misbranded and
adulterated drugs into interstate commerce with an intent to defraud
and mislead the United States, in violation of sections 301(a) and
303(a)(2) of the FD&C Act (21 U.S.C. 331(a) and 333(a)(2)).
Specifically, according to the criminal information to which he pled
guilty, Patel supervised the falsification and manipulation of assay
test results for atenolol, a prescription medication for cardiac
conditions, and he directed a subordinate chemist to falsify and
manipulate dissolution test results for methylphenidate hydrochloride

[[Page 48830]]

extended-release tablets, a prescription medication for attention
deficit and hyperactivity disorder.
By letter dated January 10, 2012, FDA's Office of Regulatory
Affairs (ORA) notified Patel of its proposal to debar him for 5 years
from providing services in any capacity to a person having an approved
or pending drug product application. ORA concluded that Patel should be
debarred for 5 years based on the four applicable considerations in
section 306(c)(3) of the FD&C Act: (1) The nature and seriousness of
his offense, (2) the nature and extent of management participation, (3)
the nature and extent of voluntary steps taken to mitigate the impact
on the public, and (4) prior convictions involving matters within FDA's
jurisdiction. ORA found that the nature and seriousness of the offense,
the nature and extent of management participation, the nature and
extent of voluntary steps to mitigate the impact on the public were
unfavorable factors for Patel. ORA found that the absence of prior
convictions involving matters within FDA's jurisdiction was a favorable
factor for Patel. ORA concluded, ``Weighing all the factors, the Agency
has determined that the unfavorable factors far outweigh the favorable
factor, and therefore warrant the imposition of a five-year permissible
debarment.''
In a letter dated January 31, 2012, through counsel, Patel
requested a hearing. In a letter dated March 1, 2012, through counsel,
Patel submitted a short summary of arguments to support his hearing
request.
Under the authority delegated to him by the Commissioner of Food
and Drugs, the Director of the Office of Scientific Integrity (OSI) has
considered Patel's submission. Hearings are granted only if there is a
genuine and substantial issue of fact. Hearings will not be granted on
issues of policy or law, on mere allegations, denials or general
descriptions of positions and contentions, or on data and information
insufficient to justify the factual determination urged (see 21 CFR
12.24(b)).
OSI has considered Patel's arguments and concludes that Patel's
arguments are unpersuasive and fail to raise a genuine and substantial
issue of fact requiring a hearing.

II. Arguments

In his hearing request, Patel generally denies: (1) Violating good
manufacturing practice requirements; (2) violating standard operating
procedures by failing to properly investigate, log, and archive
questionable, aberrant, and unacceptable laboratory results, so that
Able could conceal improprieties and continue to distribute and sell
its drug products; (3) manipulating and falsifying testing data and
information to conceal from FDA failing laboratory results relating to
Able's generic drug products; (4) creating and maintaining false,
fraudulent, and inaccurate test results to make it appear that drug
products had requisite identity, strength, quality, and purity
characteristics; and (5) creating and maintaining false, fraudulent,
and inaccurate data and records to obtain FDA approval to market new
product lines. Patel also denies that he was in a managerial position
and asserts that he took voluntary steps to mitigate the impact of his
offenses on the public by cooperating with law enforcement officials
during the investigation and subsequent prosecution.
It is unclear whether Patel's five enumerated denials are
challenges to ORA's finding that he is subject to debarment under
section 306(b)(2)(B)(i)(II) of the FD&C Act or its finding with respect
to the consideration under section 306(c)(3)(A), the nature and
seriousness of his offense. Regardless of how these denials are
directed, they do not create a genuine and substantial issue of fact
suitable for a hearing. Section 306(l) of the FD&C Act defines
conviction a Federal or State court's entry of a judgment of conviction
or acceptance of a guilty plea. In pleading guilty, Patel stated that
he was voluntarily entering his guilty plea based on an understanding
of the charges listed in the information, which included the factual
allegations that he now disputes. The court then entered a judgment of
conviction after accepting Patel's guilty plea. By pleading guilty to
the charges in the information, Patel has already admitted and been
convicted on the basis of the actions he now denies. Patel does not
dispute that the court entered a judgment of conviction or that the
court accepted his guilty plea and the factual admissions underlying
it. Therefore, Patel's denials, whether directed at the Agency's
authority to debar him or the appropriateness or period of debarment,
fail to raise a genuine and substantial issue of fact warranting a
hearing.
Patel next argues that he was not in a managerial role at the time
of the offenses and thereby appears to be challenging ORA's finding to
the contrary under section 306(c)(3)(B) of the FD&C Act. In the
attachment to Patel's plea agreement, Patel stipulated that he ``was an
organizer, leader, manager or supervisor of the relevant criminal
activity.'' Patel is bound by his stipulation from the criminal
proceedings and cannot now deny his managerial role. Further, Patel
does not provide any new information that would overcome his
stipulation that he was in a managerial role; therefore, OSI concludes
that Patel has failed to raise a genuine and substantial issue of fact
requiring a hearing with respect to ORA's finding.
Lastly, Patel claims that he took voluntary steps to mitigate the
impact on the public by cooperating with law enforcement officials
during the investigation and subsequent prosecution of the conduct
surrounding his offense. Patel appears to be responding to ORA's
finding under section 306(c)(3)(C) of the FD&C Act that there is no
information demonstrating such voluntary steps, but he does not provide
any specific information or arguments to support his bare assertion
that he cooperated with law enforcement officials. His unsupported
statement that he took voluntary steps to mitigate the effect of his
offense on the public through cooperation with law enforcement
officials does not create a genuine and substantial issue of fact that
warrants a hearing.
Based on the factual findings in the proposal to debar and on the
record, OSI finds that the proposed 5-year debarment is appropriate. In
particular, the nature and seriousness of Patel's offense weighs
significantly in favor of debarment. As stated in the proposal to
debar, ``[His] conduct created a risk of injury, undermined the
Agency's oversight of an approved drug product, undermined the
development or approval, including the process for development or
approval, of a drug product, and seriously undermined the integrity of
the Agency's regulation of drug products.'' The nature and extent of
management participation and lack of voluntary steps to mitigate the
impact on the public also weigh in favor of debarment. Although Patel
does not appear to have prior criminal convictions involving matters
within FDA's jurisdiction, this sole favorable factor is not enough to
outweigh the factors supporting debarment.

III. Findings and Order

Therefore, the Director of OSI, under section 306(b)(2)(B)(i)(II)
of the FD&C Act and under authority delegated to him by the
Commissioner of Food and Drugs, finds that: (1) Patel has been
convicted of a conspiracy to commit a felony under Federal law for
conduct relating to the regulation of a drug

[[Page 48831]]

product under the FD&C Act and (2) that the conduct which served as the
basis for the conviction undermines the process for the regulation of
drugs. FDA has considered the applicable factors listed in section
306(c)(3) of the FD&C Act and determined that a debarment of 5 years is
appropriate.
As a result of the foregoing findings, Patel is debarred for 5
years 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
September 27, 2018 (see 21 U.S.C. 335a(c)(1)(B) and (c)(2)(A)(iii) and
21 U.S.C. 321(dd)). Any person with an approved or pending drug product
application, who knowingly uses the services of Patel, in any capacity
during his period of 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 Patel, during his period of debarment, provides services in any
capacity to a person with an approved or pending drug product
application, 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 submitted by or with the
assistance of Patel during his period of debarment (section
306(c)(1)(B) of the FD&C Act).

Dated: September 21, 2018.
George M. Warren,
Director, Office of Scientific Integrity.
[FR Doc. 2018-20977 Filed 9-26-18; 8:45 am]
BILLING CODE 4164-01-P

48830 Federal Register / Vol. 83, No. 188 / Thursday, September 27, 2018 / Notices

extended-release tablets, a prescription questionable, aberrant, and manager or supervisor of the relevant
medication for attention deficit and unacceptable laboratory results, so that criminal activity.’’ Patel is bound by his
hyperactivity disorder. Able could conceal improprieties and stipulation from the criminal
By letter dated January 10, 2012, continue to distribute and sell its drug proceedings and cannot now deny his
FDA’s Office of Regulatory Affairs products; (3) manipulating and managerial role. Further, Patel does not
(ORA) notified Patel of its proposal to falsifying testing data and information provide any new information that
debar him for 5 years from providing to conceal from FDA failing laboratory would overcome his stipulation that he
services in any capacity to a person results relating to Able’s generic drug was in a managerial role; therefore, OSI
having an approved or pending drug products; (4) creating and maintaining concludes that Patel has failed to raise
product application. ORA concluded false, fraudulent, and inaccurate test a genuine and substantial issue of fact
that Patel should be debarred for 5 years results to make it appear that drug requiring a hearing with respect to
based on the four applicable products had requisite identity, ORA’s finding.
considerations in section 306(c)(3) of strength, quality, and purity Lastly, Patel claims that he took
the FD&C Act: (1) The nature and characteristics; and (5) creating and voluntary steps to mitigate the impact
seriousness of his offense, (2) the nature maintaining false, fraudulent, and on the public by cooperating with law
and extent of management participation, inaccurate data and records to obtain enforcement officials during the
(3) the nature and extent of voluntary FDA approval to market new product investigation and subsequent
steps taken to mitigate the impact on the lines. Patel also denies that he was in a prosecution of the conduct surrounding
public, and (4) prior convictions managerial position and asserts that he his offense. Patel appears to be
involving matters within FDA’s took voluntary steps to mitigate the responding to ORA’s finding under
jurisdiction. ORA found that the nature impact of his offenses on the public by section 306(c)(3)(C) of the FD&C Act
and seriousness of the offense, the cooperating with law enforcement that there is no information
nature and extent of management officials during the investigation and demonstrating such voluntary steps, but
participation, the nature and extent of subsequent prosecution. he does not provide any specific
voluntary steps to mitigate the impact It is unclear whether Patel’s five information or arguments to support his
on the public were unfavorable factors enumerated denials are challenges to bare assertion that he cooperated with
for Patel. ORA found that the absence of ORA’s finding that he is subject to law enforcement officials. His
prior convictions involving matters debarment under section unsupported statement that he took
within FDA’s jurisdiction was a 306(b)(2)(B)(i)(II) of the FD&C Act or its voluntary steps to mitigate the effect of
favorable factor for Patel. ORA finding with respect to the his offense on the public through
concluded, ‘‘Weighing all the factors, consideration under section cooperation with law enforcement
the Agency has determined that the 306(c)(3)(A), the nature and seriousness officials does not create a genuine and
unfavorable factors far outweigh the of his offense. Regardless of how these substantial issue of fact that warrants a
favorable factor, and therefore warrant denials are directed, they do not create hearing.
the imposition of a five-year permissible a genuine and substantial issue of fact Based on the factual findings in the
debarment.’’ suitable for a hearing. Section 306(l) of proposal to debar and on the record, OSI
In a letter dated January 31, 2012, the FD&C Act defines conviction a finds that the proposed 5-year
through counsel, Patel requested a Federal or State court’s entry of a debarment is appropriate. In particular,
hearing. In a letter dated March 1, 2012, judgment of conviction or acceptance of the nature and seriousness of Patel’s
through counsel, Patel submitted a short a guilty plea. In pleading guilty, Patel offense weighs significantly in favor of
summary of arguments to support his stated that he was voluntarily entering debarment. As stated in the proposal to
hearing request. his guilty plea based on an debar, ‘‘[His] conduct created a risk of
Under the authority delegated to him understanding of the charges listed in injury, undermined the Agency’s
by the Commissioner of Food and the information, which included the oversight of an approved drug product,
Drugs, the Director of the Office of factual allegations that he now disputes. undermined the development or
Scientific Integrity (OSI) has considered The court then entered a judgment of approval, including the process for
Patel’s submission. Hearings are granted conviction after accepting Patel’s guilty development or approval, of a drug
only if there is a genuine and substantial plea. By pleading guilty to the charges product, and seriously undermined the
issue of fact. Hearings will not be in the information, Patel has already integrity of the Agency’s regulation of
granted on issues of policy or law, on admitted and been convicted on the drug products.’’ The nature and extent
mere allegations, denials or general basis of the actions he now denies. Patel of management participation and lack of
descriptions of positions and does not dispute that the court entered voluntary steps to mitigate the impact
contentions, or on data and information a judgment of conviction or that the on the public also weigh in favor of
insufficient to justify the factual court accepted his guilty plea and the debarment. Although Patel does not
determination urged (see 21 CFR factual admissions underlying it. appear to have prior criminal
12.24(b)). Therefore, Patel’s denials, whether convictions involving matters within
OSI has considered Patel’s arguments directed at the Agency’s authority to FDA’s jurisdiction, this sole favorable
and concludes that Patel’s arguments debar him or the appropriateness or factor is not enough to outweigh the
are unpersuasive and fail to raise a period of debarment, fail to raise a factors supporting debarment.
genuine and substantial issue of fact genuine and substantial issue of fact
III. Findings and Order
requiring a hearing. warranting a hearing.
Patel next argues that he was not in Therefore, the Director of OSI, under
daltland on DSKBBV9HB2PROD with NOTICES

II. Arguments a managerial role at the time of the section 306(b)(2)(B)(i)(II) of the FD&C
In his hearing request, Patel generally offenses and thereby appears to be Act and under authority delegated to
denies: (1) Violating good challenging ORA’s finding to the him by the Commissioner of Food and
manufacturing practice requirements; contrary under section 306(c)(3)(B) of Drugs, finds that: (1) Patel has been
(2) violating standard operating the FD&C Act. In the attachment to convicted of a conspiracy to commit a
procedures by failing to properly Patel’s plea agreement, Patel stipulated felony under Federal law for conduct
investigate, log, and archive that he ‘‘was an organizer, leader, relating to the regulation of a drug

VerDate Sep<11>2014 17:20 Sep 26, 2018 Jkt 244001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\27SEN1.SGM 27SEN1

Federal Register / Vol. 83, No. 188 / Thursday, September 27, 2018 / Notices 48831

product under the FD&C Act and (2) the information collection titled, IHS where the duties and
that the conduct which served as the ‘‘Addendum to Declaration for Federal responsibilities involve regular contact
basis for the conviction undermines the Employment, Child Care and Indian with, or control over, Indian children;
process for the regulation of drugs. FDA Child Care Worker Positions,’’ Office of and to conduct an investigation of the
has considered the applicable factors Management and Budget (OMB) Control character of each individual who is
listed in section 306(c)(3) of the FD&C Number 0917–0028. employed, or is being considered for
Act and determined that a debarment of DATES: November 26, 2018. Your employment, in a position having
5 years is appropriate. comments regarding this information regular contact with, or control over,
As a result of the foregoing findings, collection are best assured of having full Indian children. 25 U.S.C. 3207(a)(1)
Patel is debarred for 5 years from effect if received within 60 days of the and (2). Title 25 U.S.C. 3207(a)(3)
providing services in any capacity to a date of this publication. requires regulations prescribing the
person with an approved or pending minimum standards of character for
ADDRESSES: Send your written
drug product application under sections individuals appointed to positions
comments, requests for more
505, 512, or 802 of the FD&C Act (21 involving regular contact with, or
information on the proposed collection,
U.S.C. 355, 360b, or 382), or under control over, Indian children, and
or requests to obtain a copy of the data
section 351 of the Public Health Service section 3207(b) provides that such
collection instrument and instructions
Act (42 U.S.C. 262), effective September standards shall ensure that no such
27, 2018 (see 21 U.S.C. 335a(c)(1)(B) and to Evonne Bennett-Barnes by one of the
following methods: individuals have been found guilty of,
(c)(2)(A)(iii) and 21 U.S.C. 321(dd)).
• Mail: Evonne Bennett-Barnes, or entered a plea of nolo contendere or
Any person with an approved or guilty to any felonious offense, or any
Information Collection Clearance
pending drug product application, who
Officer, 5600 Fishers Lane, Mail stop: two or more misdemeanor offenses,
knowingly uses the services of Patel, in
09E21B, Rockville, MD 20857. under Federal, State, or Tribal law
any capacity during his period of
• Email: Evonne.Bennett-Barnes@ involving crimes of violence; sexual
debarment, will be subject to civil
ihs.gov. assault, molestation, exploitation,
money penalties (section 307(a)(6) of the
• Phone: 301–443–4750. contact or prostitution; crimes against
FD&C Act (21 U.S.C. 335b(a)(6))). If
Patel, during his period of debarment, SUPPLEMENTARY INFORMATION: This persons; or offenses committed against
provides services in any capacity to a previously approved information children.
person with an approved or pending collection project was last published in In addition, 34 U.S.C. 20351 (formerly
drug product application, he will be the Federal Register (80 FR 53812) on codified at 42 U.S.C. 13041, which was
subject to civil money penalties (section September 8, 2015, and allowed 30 days transferred to 34 U.S.C. 20351) requires
307(a)(7) of the FD&C Act). In addition, for public comment. No public each agency of the Federal Government,
FDA will not accept or review any comment was received in response to and every facility operated by the
abbreviated new drug applications the notice. This notice announces our Federal Government (or operated under
submitted by or with the assistance of intent to submit this collection, which contract with the Federal Government),
Patel during his period of debarment expires November 30, 2018, to OMB for that hires (or contracts for hire)
(section 306(c)(1)(B) of the FD&C Act). approval of an extension, and to solicit individuals involved with the provision
comments on specific aspects for the of child care services to children under
Dated: September 21, 2018.
proposed information collection. the age of 18 to assure that all existing
George M. Warren, A copy of the supporting statement is
Director, Office of Scientific Integrity. and newly hired employees undergo a
available at www.regulations.gov (see criminal history background check. The
[FR Doc. 2018–20977 Filed 9–26–18; 8:45 am] Docket ID IHS_FRDOC_0001). background investigation is to be
BILLING CODE 4164–01–P Proposed Collection: Title: initiated through the personnel program
Addendum to Declaration for Federal of the applicable Federal agency. This
Employment, Child Care and Indian section requires employment
DEPARTMENT OF HEALTH AND Child Care Worker Positions (OMB No.
HUMAN SERVICES applications for individuals who are
0917–0028). Type of Information seeking work for an agency of the
Collection Request: Extension, without Federal Government, or for a facility or
Indian Health Service
revision, of currently approved program operated by (or through
[OMB NO. 0917–0028] information collection, 0917–0028, contract with) the Federal Government,
Addendum to Declaration for Federal in positions involved with the provision
Request for Public Comment: 60-Day Employment, Child Care and Indian
Proposed Information Collection: of child care services to children under
Child Care Worker Positions. There are the age of 18, to contain a question
Addendum to Declaration for Federal no program changes or adjustments in
Employment, Child Care and Indian asking whether the individual has ever
burden hours. Form(s): Addendum to been arrested for or charged with a
Child Care Worker Positions Declaration for Federal Employment, crime involving a child, and if so,
AGENCY: Indian Health Service, HHS. Child Care and Indian Child Care requiring a description of the
ACTION:Notice and request for Worker Positions. Need and Use of disposition of the arrest or charge.
comments. Request for extension of Information Collection: This is a request
for approval of the collection of Affected Public: Individuals and
approval. households. Type of Respondents:
information as required by section 408
SUMMARY: In compliance with the of the Indian Child Protection and Individuals.
daltland on DSKBBV9HB2PROD with NOTICES

Paperwork Reduction Act of 1995, Family Violence Prevention Act, Public The table below provides: Types of
which requires 60 days for public Law (Pub. L.) 101–630, 104 Stat. 4544, data collection instruments, Estimated
comment on proposed information and 25 United States Code (U.S.C.) number of respondents, Number of
collection projects, the Indian Health §§ 3201–3210. responses per respondent, Average
Service (IHS) invites the general public The IHS is required to compile a list burden hour per response, and Total
to take this opportunity to comment on of all authorized positions within the annual burden hour(s).

VerDate Sep<11>2014 17:20 Sep 26, 2018 Jkt 244001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\27SEN1.SGM 27SEN1

Document Created: 2018-09-27 01:04:40
Document Modified: 2018-09-27 01:04:40

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		The order is applicable September 27, 2018.
Contact		Rachael Vieder Linowes, Office of Scientific Integrity, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4206, Silver Spring, MD 20993, 240-402-5931.
FR Citation		83 FR 48829

83 FR 48829 - Dilip Patel; Denial of Hearing; Final Debarment Order

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 188 (September 27, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration