83 FR 49099 - John D. McCoy; Denial of Hearing; Final Debarment Order
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 189 (September 28, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 189 (September 28, 2018)
| Page Range | 49099-49101 | |
| FR Document | 2018-21211 |
[Federal Register Volume 83, Number 189 (Friday, September 28, 2018)] [Notices] [Pages 49099-49101] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-21211] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0613] John D. McCoy; Denial of Hearing; Final Debarment Order AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is denying a request for a hearing submitted by John D. McCoy (McCoy) and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring McCoy for 4 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 McCoy was convicted of a misdemeanor 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 McCoy's debarment, FDA has considered the relevant factors listed in the FD&C Act. McCoy has 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 28, 2018. ADDRESSES: Any application for termination of debarment by McCoy under section 306(d) of the FD&C Act (application) may be submitted as follows: Electronic SubmissionsFederal 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- 2011-N-0613. An application will be placed in the docket and, unless submitted as [[Page 49100]] ``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)(I) of the FD&C Act (21 U.S.C. 335a(b)(2)(B)(i)(I)) permits FDA to debar an individual if it finds that: (1) The individual has been convicted of a misdemeanor under Federal law for conduct relating to the development or approval, including the process for development or approval, of a drug product or otherwise relating to the regulation of a drug product under the FD&C Act and (2) the type of conduct that served as the basis for the conviction undermines the process for the regulation of drugs. On April 20, 2009, in the U.S. District Court for the District of Arizona, McCoy pled guilty to a misdemeanor, namely adulterating a drug while held for sale after shipment in interstate commerce in violation of sections 301(k), 303(a)(1), and 501(d) of the FD&C Act (21 U.S.C. 331(k), 333(a)(1) and 351(d)). The conduct underlying the conviction involved the adulteration of BOTOX[supreg]/BOTOX[supreg] Cosmetic (BOTOX[supreg]). BOTOX[supreg] is a biological product derived from Botulinum Toxin Type A that is manufactured by Allergan, Inc., and was approved by FDA for use on humans. Toxin Research International was an Arizona corporation that marketed and sold TRI-Toxin, a Botulinum Toxin Type A product that was neither approved nor licensed by FDA. According to the records of the criminal proceedings, McCoy, while a physician at Skinovative Laser Center, mixed FDA-approved BOTOX[supreg] with TRI- toxin, while the BOTOX[supreg] was held for sale after shipment in interstate commerce, such that the BOTOX[supreg] was adulterated under section 501(d) of the FD&C Act. By letter dated October 24, 2011, FDA's Office of Regulatory Affairs (ORA) notified McCoy of its proposal to debar him for 4 years from providing services in any capacity to a person having an approved or pending drug product application. The proposal outlined findings concerning three relevant factors ORA considered in determining the appropriateness and period of debarment, as provided in section 306(c)(3) of the FD&C Act. ORA found that the nature and seriousness of the offense and the nature and extent of voluntary steps to mitigate the effect on the public were unfavorable factors for McCoy. The absence of prior convictions involving matters within FDA's jurisdiction was a favorable factor. ORA concluded, ``Weighing all the factors, particularly the nature and seriousness of the conduct underlying your conviction, the Agency has determined that the unfavorable factors outweigh the favorable factors, and therefore warrant the imposition of a four year permissible debarment in this case.'' In a letter dated November 23, 2011, through counsel, McCoy requested a hearing on the proposal. In his hearing request, McCoy argues that there are disputed issues of material fact that FDA must consider, under section 306(c)(3) of the FD&C Act, in determining the appropriateness and period of debarment. McCoy also indicated that additional information justifying the hearing would be forthcoming. More than 60 days have passed from the date McCoy received ORA's letter, and McCoy has not filed any additional information. Under the authority delegated to him by the Commissioner of Food and Drugs, the Director of the Office of Scientific Integrity (OSI) has considered McCoy's request for a hearing. 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 Sec. 12.24(b) (21 CFR 12.24(b))). OSI has considered McCoy's arguments and concludes that they are unpersuasive and fail to raise a genuine and substantial issue of fact requiring a hearing. II. Arguments In his hearing request, McCoy first contends that there are disputed issues of material fact with respect to whether he voluntarily acted to mitigate the impact of his offense on the public (see section 306(c)(3)(C) of the FD&C Act). ORA found no evidence that McCoy took any voluntary steps to mitigate the impact on the public. McCoy has not provided any specific allegations or evidence supporting his general assertion that the facts underlying ORA's findings are in dispute. Although McCoy indicated that he would submit additional information supporting his hearing request, he has not done so. Under Sec. 12.24(b)(2), a hearing will not be granted on the basis of mere allegations or denials or general descriptions of positions and contentions. McCoy's bare assertion that there are disputed issues of fact with respect to that consideration fails to create a genuine and substantial issue of fact that warrants a hearing. Upon similar reasoning, McCoy's claim that the disputed issues of fact are not limited to those raised in his hearing request also falls far short of justifying a hearing. Finally, McCoy contends that there are disputed issues of material fact with respect to whether, under section 306(c)(3)(D) of the FD&C Act, the extent to which changes in ownership, management, or operations has corrected the causes of any offense involved and provide reasonable assurances that the offense will not [[Page 49101]] occur again. Yet, again, McCoy has not provided any specific allegations or evidence to challenge ORA's determination that this consideration does not apply to him. FDA need only address the considerations in section 306(c)(3) of the FD&C Act ``where applicable.'' The considerations in section 306(c)(3) of the FD&C Act are not only for individuals but also for corporations, partnerships, and associations subject to permissive debarment. The consideration at issue does not typically apply to individuals because individuals are incapable of changes in ownership or management and could only alter the current operations of a business enterprise in which they are currently engaged. Even assuming arguendo that an individual could point to changes in his or her current business practices as an applicable consideration under section 306(c)(3) of the FD&C Act, McCoy's unsubstantiated contention that there are disputed issues of fact with respect to that consideration fails to 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 a 4-year debarment is appropriate. Although McCoy has no previous criminal convictions related to matters within the jurisdiction of FDA, this sole positive factor does not counterbalance the nature and seriousness of his offense and lack of voluntary steps taken to mitigate the effect on the public. As noted in the proposal to debar, McCoy's actions occurred on a repeated basis, and ``[his] conduct created a risk of injury to [his] patients . . ., undermined the Agency's oversight of an approved drug product, and seriously undermined the integrity of the Agency's regulation of drug products.'' III. Findings and Order Therefore, the Director of OSI, under section 306(b)(2)(B)(i)(I) of the FD&C Act and under authority delegated to him by the Commissioner of Food and Drugs, finds that: (1) McCoy has been convicted of a misdemeanor under Federal law for conduct relating to the development or approval, including the process for development or approval, of a drug product or otherwise relating to the regulation of a drug product under the FD&C Act and (2) 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 4 years is appropriate. As a result of the foregoing findings, McCoy is debarred for 4 years from providing services in any capacity to a person with an approved or pending drug product application under section 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) (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 McCoy, 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 McCoy, 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 McCoy during his period of debarment (section 306(c)(1)(B) of the FD&C Act). Dated: September 25, 2018. George M. Warren, Director, Office of Scientific Integrity. [FR Doc. 2018-21211 Filed 9-27-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Notices 49099
whether a 510(k) is appropriate for practices regulation (21 CFR 10.115). Information/default.htm. Persons
review as a Special 510(k). In general, a The draft guidance, when finalized, will unable to download an electronic copy
change to an existing device may be represent the current thinking of FDA of ‘‘The Special 510(k) Program’’ may
appropriate for a Special 510(k) when: on ‘‘The Special 510(k) Program.’’ It send an email request to CDRH-
(1) The proposed change is made and does not establish any rights for any Guidance@fda.hhs.gov to receive an
submitted by the manufacturer person and is not binding on FDA or the electronic copy of the document. Please
authorized to market the existing public. You can use an alternative use the document number 18008 to
device; (2) performance data are approach if it satisfies the requirements identify the guidance you are
unnecessary, or if performance data are of the applicable statutes and requesting.
necessary, well-established methods are regulations. This guidance is not subject
available to evaluate the change; and (3) to Executive Order 12866. IV. Paperwork Reduction Act of 1995
all performance data necessary to
III. Electronic Access This draft guidance refers to
support substantial equivalence can be
reviewed in a summary or risk analysis Persons interested in obtaining a copy previously approved collections of
format. of the draft guidance may do so by information. These collections of
When finalized, this guidance will downloading an electronic copy from information are subject to review by the
supersede the Special 510(k) policy in the internet. A search capability for all Office of Management and Budget
the 1998 guidance entitled ‘‘The New Center for Devices and Radiological (OMB) under the Paperwork Reduction
510(k) Paradigm: Alternate Approaches Health guidance documents is available Act of 1995 (44 U.S.C. 3501–3520). The
to Demonstrating Substantial at http://www.fda.gov/MedicalDevices/ collections of information in the
Equivalence in Premarket DeviceRegulationandGuidance/ following FDA regulations have been
Notifications.’’ GuidanceDocuments/default.htm. This approved by OMB as listed in the
guidance document is also available at following table:
II. Significance of Guidance https://www.regulations.gov or https://
This draft guidance is being issued www.fda.gov/BiologicsBloodVaccines/
consistent with FDA’s good guidance GuidanceComplianceRegulatory
OMB control
21 CFR part; guidance; or FDA form Topic No.
807, subpart E .......................................... Premarket Notification .................................................................................................. 0910–0120
801 ............................................................ Medical Device Labeling Regulations .......................................................................... 0910–0485
820 ............................................................ Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation ..... 0910–0073
Dated: September 24, 2018. FD&C Act and that the conduct as a manufacturing process. Please note
Leslie Kux, underlying the conviction undermines that if you include your name, contact
Associate Commissioner for Policy. the process for the regulation of drugs. information, or other information that
[FR Doc. 2018–21141 Filed 9–27–18; 8:45 am] In determining the appropriateness and identifies you in the body of your
BILLING CODE 4164–01–P
period of McCoy’s debarment, FDA has application, that information will be
considered the relevant factors listed in posted on https://www.regulations.gov.
the FD&C Act. McCoy has failed to file • If you want to submit an
DEPARTMENT OF HEALTH AND with the Agency information and application with confidential
HUMAN SERVICES analyses sufficient to create a basis for information that you do not wish to be
a hearing concerning this action. made available to the public, submit the
Food and Drug Administration DATES: The order is applicable application as a written/paper
September 28, 2018. submission and in the manner detailed
[Docket No. FDA–2011–N–0613] (see ‘‘Written/Paper Submissions’’ and
ADDRESSES: Any application for
termination of debarment by McCoy ‘‘Instructions’’).
John D. McCoy; Denial of Hearing;
Final Debarment Order under section 306(d) of the FD&C Act Written/Paper Submissions
(application) may be submitted as
AGENCY: Food and Drug Administration, follows: Submit written/paper submissions as
HHS. follows:
Electronic Submissions • Mail/Hand delivery/Courier (for
ACTION: Notice.
• Federal eRulemaking Portal: written/paper submissions): Dockets
SUMMARY: The Food and Drug https://www.regulations.gov. Follow the Management Staff (HFA–305), Food and
Administration (FDA) is denying a instructions for submitting comments. Drug Administration, 5630 Fishers
request for a hearing submitted by John An application submitted electronically, Lane, Rm. 1061, Rockville, MD 20852.
D. McCoy (McCoy) and is issuing an including attachments, to https:// • For a written/paper application
order under the Federal Food, Drug, and www.regulations.gov will be posted to submitted to the Dockets Management
Cosmetic Act (FD&C Act) debarring the docket unchanged. Because your Staff, FDA will post your application, as
McCoy for 4 years from providing application will be made public, you are well as any attachments, except for
amozie on DSK3GDR082PROD with NOTICES1
services in any capacity to a person that solely responsible for ensuring that your information submitted, marked and
has an approved or pending drug application does not include any identified, as confidential, if submitted
product application. FDA bases this confidential information that you or a as detailed in ‘‘Instructions.’’
order on a finding that McCoy was third party may not wish to be posted, Instructions: Your application must
convicted of a misdemeanor under such as medical information, your or include the Docket No. FDA–2011–N–
Federal law for conduct relating to the anyone else’s Social Security number, or 0613. An application will be placed in
regulation of a drug product under the confidential business information, such the docket and, unless submitted as
VerDate Sep<11>2014 19:22 Sep 27, 2018 Jkt 244001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\28SEN1.SGM 28SEN1](https://thefederalregister.org/doc/83_FR_49288/page/1.svg)
![Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Notices 49101
occur again. Yet, again, McCoy has not As a result of the foregoing findings, Answers to commonly asked questions
provided any specific allegations or McCoy is debarred for 4 years from including information regarding special
evidence to challenge ORA’s providing services in any capacity to a accommodations due to a disability,
determination that this consideration person with an approved or pending visitor parking, and transportation may
does not apply to him. FDA need only drug product application under section be accessed at: https://www.fda.gov/
address the considerations in section 505, 512, or 802 of the FD&C Act (21 AdvisoryCommittees/AboutAdvisory
306(c)(3) of the FD&C Act ‘‘where U.S.C. 355, 360b, or 382), or under Committees/ucm408555.htm.
applicable.’’ The considerations in section 351 of the Public Health Service For those unable to attend in person,
section 306(c)(3) of the FD&C Act are Act (42 U.S.C. 262), effective (see DATES) the meeting will also be webcast and
not only for individuals but also for (21 U.S.C. 335a(c)(1)(B) and (c)(2)(A)(iii) will be available at the following link:
corporations, partnerships, and and 21 U.S.C. 321(dd)). Any person https://collaboration.fda.gov/
associations subject to permissive with an approved or pending drug vrbpac1118/.
debarment. The consideration at issue product application, who knowingly FOR FURTHER INFORMATION CONTACT:
does not typically apply to individuals uses the services of McCoy, in any Serina Hunter-Thomas, Center for
because individuals are incapable of capacity during his period of Biologics Evaluation and Research,
changes in ownership or management debarment, will be subject to civil Food and Drug Administration, 10903
and could only alter the current money penalties (section 307(a)(6) of the New Hampshire Ave., Bldg. 71, Rm.
operations of a business enterprise in FD&C Act (21 U.S.C. 335b(a)(6))). If 6338, Silver Spring, MD 20993–0002,
which they are currently engaged. Even McCoy, during his period of debarment, 240–402–5771, serina.hunter-thomas@
assuming arguendo that an individual provides services in any capacity to a fda.hhs.gov or FDA Advisory Committee
could point to changes in his or her person with an approved or pending Information Line, 1–800–741–8138
current business practices as an drug product application, he will be (301–443–0572 in the Washington, DC
applicable consideration under section subject to civil money penalties (section area). A notice in the Federal Register
306(c)(3) of the FD&C Act, McCoy’s 307(a)(7) of the FD&C Act). In addition, about last minute modifications that
unsubstantiated contention that there FDA will not accept or review any impact a previously announced
are disputed issues of fact with respect abbreviated new drug applications advisory committee meeting cannot
to that consideration fails to create a submitted by or with the assistance of always be published quickly enough to
genuine and substantial issue of fact McCoy during his period of debarment provide timely notice. Therefore, you
that warrants a hearing. (section 306(c)(1)(B) of the FD&C Act). should always check the Agency’s
Based on the factual findings in the
Dated: September 25, 2018. website at https://www.fda.gov/
proposal to debar and on the record, OSI
George M. Warren, AdvisoryCommittees/default.htm and
finds that a 4-year debarment is
Director, Office of Scientific Integrity. scroll down to the appropriate advisory
appropriate. Although McCoy has no
committee meeting link, or call the
previous criminal convictions related to [FR Doc. 2018–21211 Filed 9–27–18; 8:45 am]
advisory committee information line to
matters within the jurisdiction of FDA, BILLING CODE 4164–01–P
learn about possible modifications
this sole positive factor does not
before coming to the meeting.
counterbalance the nature and
seriousness of his offense and lack of DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION:
voluntary steps taken to mitigate the HUMAN SERVICES Agenda: On November 8, 2018, the
effect on the public. As noted in the Center for Biologics Evaluation and
proposal to debar, McCoy’s actions Food and Drug Administration Research’s (CBER) VRBPAC committee
occurred on a repeated basis, and ‘‘[his] will meet in open session to hear an
[Docket No. FDA–2018–N–3424]
conduct created a risk of injury to [his] overview of the research program in the
patients . . ., undermined the Agency’s Vaccines and Related Biological Laboratory of DNA Viruses (LDV),
oversight of an approved drug product, Products Advisory Committee; Notice Division of Viral Products (DVP), Office
and seriously undermined the integrity of Meeting of Vaccines Research and Review
of the Agency’s regulation of drug (OVRR), CBER, FDA. FDA intends to
products.’’ AGENCY: Food and Drug Administration, make background material available to
HHS. the public no later than 2 business days
III. Findings and Order ACTION: Notice. before the meeting. If FDA is unable to
Therefore, the Director of OSI, under post the background material on its
section 306(b)(2)(B)(i)(I) of the FD&C SUMMARY: The Food and Drug website prior to the meeting, the
Act and under authority delegated to Administration (FDA) announces a background material will be made
him by the Commissioner of Food and forthcoming public advisory committee publicly available at the location of the
Drugs, finds that: (1) McCoy has been meeting of the Vaccines and Related advisory committee meeting, and the
convicted of a misdemeanor under Biological Products Advisory background material will be posted on
Federal law for conduct relating to the Committee (VRBPAC). The general FDA’s website after the meeting.
development or approval, including the function of the committee is to provide Background material is available at
process for development or approval, of advice and recommendations to the https://www.fda.gov/Advisory
a drug product or otherwise relating to Agency on FDA’s regulatory issues. At Committees/Calendar/default.htm.
the regulation of a drug product under least one portion of the meeting will be Scroll down to the appropriate advisory
the FD&C Act and (2) the conduct which closed to the public. committee meeting link.
amozie on DSK3GDR082PROD with NOTICES1
served as the basis for the conviction DATES: The meeting will be held on Procedure: On November 8, 2018,
undermines the process for the November 8, 2018, from 11 a.m. to 2:45 from 11 a.m. to 1:50 p.m., the meeting
regulation of drugs. FDA has considered p.m. is open to the public. Interested persons
the applicable factors listed in section ADDRESSES: FDA White Oak Campus, may present data, information, or views,
306(c)(3) of the FD&C Act and 10903 New Hampshire Ave., Bldg. 31 orally or in writing, on issues pending
determined that a debarment of 4 years Conference Center, the Great Room (Rm. before the committee. Written
is appropriate. 1503), Silver Spring, MD 20993–0002. submissions may be made to the contact
VerDate Sep<11>2014 19:22 Sep 27, 2018 Jkt 244001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\28SEN1.SGM 28SEN1](https://thefederalregister.org/doc/83_FR_49288/page/3.svg)
Document Created: 2018-09-28 01:23:19
Document Modified: 2018-09-28 01:23:19
| 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 28, 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 49099 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR