83 FR 47926 - Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank; Draft Guidance for Food and Drug Administration Staff, Responsible Parties, and Submitters of Certain Applications and Submissions to the Food and Drug Administration; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 184 (September 21, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 184 (September 21, 2018)
| Page Range | 47926-47927 | |
| FR Document | 2018-20560 |
[Federal Register Volume 83, Number 184 (Friday, September 21, 2018)] [Notices] [Pages 47926-47927] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-20560] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-0787] Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank; Draft Guidance for Food and Drug Administration Staff, Responsible Parties, and Submitters of Certain Applications and Submissions to the Food and Drug Administration; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank; Draft Guidance for FDA Staff, Responsible Parties, and Submitters of Certain Applications and Submissions to FDA.'' The draft guidance provides the current thinking of FDA's Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), and Center for Devices and Radiological Health (CDRH) regarding civil money penalties that may be assessed against responsible parties and/or submitters of certain applications and submissions to FDA regarding drug products, biological products, and device products who violate applicable Federal Food, Drug, and Cosmetic Act (FD&C Act) prohibitions relating to requirements, including implementing regulations, submitting registration and/or results information to the ClinicalTrials.gov data bank, and/or certain certifications to FDA. DATES: Submit either electronic or written comments on the draft guidance by November 20, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2018-D-0787 for ``Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank; Draft Guidance for FDA Staff, Responsible Parties, and Submitters of Certain Applications and Submissions to FDA.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper [[Page 47927]] submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Patrick McNeilly, Office of Good Clinical Practice, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32, Rm. 5172, Silver Spring, MD 20993-0002, 301-796-2941. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank; Draft Guidance for FDA Staff, Responsible Parties, and Submitters of Certain Applications and Submissions to FDA.'' The draft guidance provides the current thinking of FDA's CDER, CBER, and CDRH (Center, or collectively Centers), regarding civil money penalties for responsible parties and/or submitters of certain applications and submissions to FDA regarding drug products, biological products, or device products (submitters) who violate applicable FD&C Act (21 U.S.C. 301 et seq.) prohibitions relating to requirements under section 402(j) of the Public Health Service Act (PHS Act) (42 U.S.C. 282(j)), including its implementing regulations in 42 CFR part 11, to submit registration and/or results information to the ClinicalTrials.gov data bank and/or certain certifications to FDA. The draft guidance is intended to address several questions. First, how the Centers identify whether responsible parties have failed to submit required clinical trial registration and/or results information to the ClinicalTrials.gov data bank or submitted false or misleading information to the data bank, and whether submitters have failed to submit the certification required by section 402(j)(5)(B) of the PHS Act (42 U.S.C. 282(j)(5)(B)) to FDA or knowingly submitted a false certification to FDA. Second, under what circumstances a Center may decide to seek civil money penalties against a responsible party or submitter. Third, what procedures apply when a Center seeks civil money penalties; and finally, what civil money penalty amounts may be assessed for: (1) Failing to submit required clinical trial registration and/or results information to the ClinicalTrials.gov data bank, (2) knowingly submitting false or misleading clinical trial information to the data bank, (3) failing to submit the required certification to FDA, or (4) knowingly submitting a false certification to FDA. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on civil money penalties relating to the ClinicalTrials.gov data bank. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. II. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Dated: September 17, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-20560 Filed 9-20-18; 8:45 am] BILLING CODE 4164-01-P
![47926 Federal Register / Vol. 83, No. 184 / Friday, September 21, 2018 / Notices
harm and the risk of tobacco-related ucm619683.htm or https:// Electronic Submissions
disease to individual tobacco users and www.regulations.gov. Submit electronic comments in the
will benefit the health of the population Dated: September 17, 2018. following way:
as a whole taking into account both • Federal eRulemaking Portal:
Leslie Kux,
users of tobacco products and persons https://www.regulations.gov. Follow the
who do not currently use tobacco Associate Commissioner for Policy.
[FR Doc. 2018–20562 Filed 9–20–18; 8:45 am]
instructions for submitting comments.
products. Section 911(g)(4) of the FD&C Comments submitted electronically,
Act describes factors that FDA must take BILLING CODE 4164–01–P
including attachments, to https://
into account in evaluating whether a www.regulations.gov will be posted to
tobacco product benefits the health of the docket unchanged. Because your
individuals and the population as a DEPARTMENT OF HEALTH AND
HUMAN SERVICES comment will be made public, you are
whole. solely responsible for ensuring that your
FDA is issuing this notice to inform Food and Drug Administration comment does not include any
the public that a MRTPA for confidential information that you or a
Copenhagen® Snuff Fine Cut submitted third party may not wish to be posted,
by U.S. Smokeless Tobacco Co. LLC has [Docket No. FDA–2018–D–0787]
such as medical information, your or
been filed and is being made available anyone else’s Social Security number, or
Civil Money Penalties Relating to the
for public comment. confidential business information, such
ClinicalTrials.gov Data Bank; Draft
MR0000108: Copenhagen® Snuff Fine Guidance for Food and Drug as a manufacturing process. Please note
Cut Administration Staff, Responsible that if you include your name, contact
Parties, and Submitters of Certain information, or other information that
FDA will post the application identifies you in the body of your
Applications and Submissions to the
documents, including any amendments, comments, that information will be
Food and Drug Administration;
for public comment in batches on a posted on https://www.regulations.gov.
Availability
rolling basis as they are redacted in • If you want to submit a comment
accordance with applicable laws. In this AGENCY: Food and Drug Administration, with confidential information that you
document, FDA is announcing the HHS. do not wish to be made available to the
availability of the first batch of public, submit the comment as a
application documents. FDA intends to ACTION: Notice of availability. written/paper submission and in the
establish a closing date for the comment manner detailed (see ‘‘Written/Paper
period that is both at least 180 days after SUMMARY: The Food and Drug Submissions’’ and ‘‘Instructions’’).
the date of this notice and at least 30 Administration (FDA or Agency) is
days after the final documents from the announcing the availability of a draft Written/Paper Submissions
application are made available for guidance for industry entitled ‘‘Civil Submit written/paper submissions as
public comment. FDA will announce Money Penalties Relating to the follows:
the closing date at least 30 days in ClinicalTrials.gov Data Bank; Draft • Mail/Hand delivery/Courier (for
advance. FDA believes that this Guidance for FDA Staff, Responsible written/paper submissions): Dockets
comment period is appropriate given Parties, and Submitters of Certain Management Staff (HFA–305), Food and
the volume and complexity of the Applications and Submissions to FDA.’’ Drug Administration, 5630 Fishers
application being posted. FDA will The draft guidance provides the current Lane, Rm. 1061, Rockville, MD 20852.
notify the public about the availability thinking of FDA’s Center for Drug • For written/paper comments
of additional application documents Evaluation and Research (CDER), Center submitted to the Dockets Management
and the comment period closing date for Biologics Evaluation and Research Staff, FDA will post your comment, as
via the Agency’s web page for the (CBER), and Center for Devices and well as any attachments, except for
MRTPA (see section II) and by other Radiological Health (CDRH) regarding information submitted, marked and
means of public communication, such civil money penalties that may be identified, as confidential, if submitted
as by email to individuals who have assessed against responsible parties as detailed in ‘‘Instructions.’’
signed up to receive email alerts. To and/or submitters of certain Instructions: All submissions received
receive email alerts, visit FDA’s email applications and submissions to FDA must include the Docket No. FDA–
subscription service management regarding drug products, biological 2018–D–0787 for ‘‘Civil Money
website (http://go.fda.gov/ products, and device products who Penalties Relating to the
subscriptionmanagement), provide an violate applicable Federal Food, Drug, ClinicalTrials.gov Data Bank; Draft
email address, scroll down to the and Cosmetic Act (FD&C Act) Guidance for FDA Staff, Responsible
‘‘Tobacco’’ heading, select ‘‘Modified prohibitions relating to requirements, Parties, and Submitters of Certain
Risk Tobacco Product Application including implementing regulations, Applications and Submissions to FDA.’’
Updates’’, and click ‘‘Submit’’. To submitting registration and/or results Received comments will be placed in
encourage public participation information to the ClinicalTrials.gov the docket and, except for those
consistent with section 911(e) of the data bank, and/or certain certifications submitted as ‘‘Confidential
FD&C Act, FDA is making the redacted to FDA. Submissions,’’ publicly viewable at
MRTPAs that are the subject of this https://www.regulations.gov or at the
DATES: Submit either electronic or
notice available electronically (see Dockets Management Staff between 9
daltland on DSKBBV9HB2PROD with NOTICES
written comments on the draft guidance
section II). a.m. and 4 p.m., Monday through
by November 20, 2018 to ensure that the
Friday.
II. Electronic Access Agency considers your comment on this
• Confidential Submissions—To
draft guidance before it begins work on
Persons with access to the internet submit a comment with confidential
the final version of the guidance.
may obtain the documents at either information that you do not wish to be
https://www.fda.gov/TobaccoProducts/ ADDRESSES: You may submit comments made publicly available, submit your
Labeling/MarketingandAdvertising/ on any guidance at any time as follows: comments only as a written/paper
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![Federal Register / Vol. 83, No. 184 / Friday, September 21, 2018 / Notices 47927
submission. You should submit two Avenue, Bldg. 32, Rm. 5172, Silver You can use an alternative approach if
copies total. One copy will include the Spring, MD 20993–0002, 301–796–2941. it satisfies the requirements of the
information you claim to be confidential SUPPLEMENTARY INFORMATION: applicable statutes and regulations. This
with a heading or cover note that states guidance is not subject to Executive
‘‘THIS DOCUMENT CONTAINS I. Background Order 12866.
CONFIDENTIAL INFORMATION.’’ The FDA is announcing the availability of II. Electronic Access
Agency will review this copy, including a draft guidance for industry entitled
the claimed confidential information, in ‘‘Civil Money Penalties Relating to the Persons with access to the internet
its consideration of comments. The ClinicalTrials.gov Data Bank; Draft may obtain the draft guidance at either
second copy, which will have the Guidance for FDA Staff, Responsible https://www.fda.gov/Drugs/Guidance
claimed confidential information Parties, and Submitters of Certain ComplianceRegulatoryInformation/
redacted/blacked out, will be available Applications and Submissions to FDA.’’ Guidances/default.htm or https://
for public viewing and posted on The draft guidance provides the current www.regulations.gov.
https://www.regulations.gov. Submit thinking of FDA’s CDER, CBER, and Dated: September 17, 2018.
both copies to the Dockets Management CDRH (Center, or collectively Centers), Leslie Kux,
Staff. If you do not wish your name and regarding civil money penalties for Associate Commissioner for Policy.
contact information to be made publicly responsible parties and/or submitters of [FR Doc. 2018–20560 Filed 9–20–18; 8:45 am]
available, you can provide this certain applications and submissions to BILLING CODE 4164–01–P
information on the cover sheet and not FDA regarding drug products, biological
in the body of your comments and you products, or device products
must identify this information as (submitters) who violate applicable DEPARTMENT OF HEALTH AND
‘‘confidential.’’ Any information marked FD&C Act (21 U.S.C. 301 et seq.) HUMAN SERVICES
as ‘‘confidential’’ will not be disclosed prohibitions relating to requirements
except in accordance with 21 CFR 10.20 under section 402(j) of the Public Health National Institutes of Health
and other applicable disclosure law. For Service Act (PHS Act) (42 U.S.C. 282(j)),
more information about FDA’s posting including its implementing regulations Center for Scientific Review; Notice of
of comments to public dockets, see 80 in 42 CFR part 11, to submit registration Closed Meetings
FR 56469, September 18, 2015, or access and/or results information to the Pursuant to section 10(d) of the
the information at: https://www.gpo.gov/ ClinicalTrials.gov data bank and/or Federal Advisory Committee Act, as
fdsys/pkg/FR-2015-09-18/pdf/2015- certain certifications to FDA. The draft amended, notice is hereby given of the
23389.pdf. guidance is intended to address several following meetings.
Docket: For access to the docket to questions. First, how the Centers The meetings will be closed to the
read background documents or the identify whether responsible parties public in accordance with the
electronic and written/paper comments have failed to submit required clinical provisions set forth in sections
received, go to https:// trial registration and/or results 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
www.regulations.gov and insert the information to the ClinicalTrials.gov as amended. The grant applications and
docket number, found in brackets in the data bank or submitted false or the discussions could disclose
heading of this document, into the misleading information to the data bank, confidential trade secrets or commercial
‘‘Search’’ box and follow the prompts and whether submitters have failed to property such as patentable material,
and/or go to the Dockets Management submit the certification required by and personal information concerning
Staff, 5630 Fishers Lane, Rm. 1061, section 402(j)(5)(B) of the PHS Act (42 individuals associated with the grant
Rockville, MD 20852. U.S.C. 282(j)(5)(B)) to FDA or knowingly applications, the disclosure of which
You may submit comments on any submitted a false certification to FDA. would constitute a clearly unwarranted
guidance at any time (see 21 CFR Second, under what circumstances a invasion of personal privacy.
10.115(g)(5)). Center may decide to seek civil money Name of Committee: Center for Scientific
penalties against a responsible party or Review Special Emphasis Panel; Evaluation
Submit written requests for single submitter. Third, what procedures apply
copies of the draft guidance to the and Implementation of Patient Care.
when a Center seeks civil money Date: October 11, 2018.
Division of Drug Information, Center for penalties; and finally, what civil money Time: 10:00 a.m. to 12:00 p.m.
Drug Evaluation and Research, Food penalty amounts may be assessed for: Agenda: To review and evaluate grant
and Drug Administration, 10001 New (1) Failing to submit required clinical applications.
Hampshire Ave., Hillandale Building, trial registration and/or results Place: Capital Skyline Hotel, 10 I Street
4th Floor, Silver Spring, MD 20993– information to the ClinicalTrials.gov SW, Washington, DC 20024.
0002, or the Office of Communication, Contact Person: Gabriel B. Fosu, Ph.D.,
data bank, (2) knowingly submitting Scientific Review Officer, Center for
Outreach and Development, Center for false or misleading clinical trial
Biologics Evaluation and Research, Scientific Review, National Institutes of
information to the data bank, (3) failing Health, 6701 Rockledge Drive, Room 3108,
Food and Drug Administration, 10903 to submit the required certification to MSC 7808, Bethesda, MD 20892, (301) 435–
New Hampshire Ave., Bldg. 71, Rm. FDA, or (4) knowingly submitting a false 3562, fosug@csr.nih.gov.
3128, Silver Spring, MD 20993–0002. certification to FDA. Name of Committee: Center for Scientific
Send one self-addressed adhesive label This draft guidance is being issued Review Special Emphasis Panel; PAR Panel:
to assist that office in processing your consistent with FDA’s good guidance Academic-Industrial Partnerships Research
daltland on DSKBBV9HB2PROD with NOTICES
requests. See the SUPPLEMENTARY practices regulation (21 CFR 10.115). for Cancer Diagnosis and Treatment.
INFORMATION section for electronic Date: October 15–16, 2018.
The draft guidance, when finalized, will
access to the draft guidance document. represent the current thinking of FDA
Time: 8:00 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant
FOR FURTHER INFORMATION CONTACT: on civil money penalties relating to the applications.
Patrick McNeilly, Office of Good ClinicalTrials.gov data bank. It does not Place: Hyatt Regency Bethesda, One
Clinical Practice, Food and Drug establish any rights for any person and Bethesda Metro Center, 7400 Wisconsin
Administration, 10903 New Hampshire is not binding on FDA or the public. Avenue, Bethesda, MD 20814.
VerDate Sep<11>2014 17:30 Sep 20, 2018 Jkt 244001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\21SEN1.SGM 21SEN1](https://thefederalregister.org/doc/83_FR_48110/page/2.svg)
Document Created: 2018-09-21 00:23:05
Document Modified: 2018-09-21 00:23:05
| 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 of availability. | |
| Dates | Submit either electronic or written comments on the draft guidance by November 20, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Patrick McNeilly, Office of Good Clinical Practice, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32, Rm. 5172, Silver Spring, MD 20993-0002, 301-796-2941. | |
| FR Citation | 83 FR 47926 |
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