83 FR 61646 - Agency Information Collection Activities; Proposed Collection; Comment Request; Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 231 (November 30, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 231 (November 30, 2018)
| Page Range | 61646-61648 | |
| FR Document | 2018-26032 |
[Federal Register Volume 83, Number 231 (Friday, November 30, 2018)] [Notices] [Pages 61646-61648] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-26032] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0597] Agency Information Collection Activities; Proposed Collection; Comment Request; Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public [[Page 61647]] comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with oversight of clinical investigations, a risk-based approach to monitoring. DATES: Submit either electronic or written comments on the collection of information by January 29, 2019. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before January 29, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of January 29, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. 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-2011-D-0597 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.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. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected]. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring--21 CFR Parts 312 and 812 OMB Control Number 0910-0733--Extension This information collection supports reporting and recordkeeping found in Agency guidance. Under parts 312 and 812 (21 CFR parts 312 and 812), sponsors are required to provide [[Page 61648]] appropriate oversight of their clinical investigations to ensure adequate protection of the rights, welfare, and safety of human subjects and to ensure the quality and integrity of the resulting data submitted to FDA. As part of this oversight, sponsors of clinical investigations are required to monitor the conduct and progress of their clinical investigations. The regulations do not specify how sponsors are to conduct monitoring of clinical investigations and are, therefore, compatible with a range of approaches to monitoring. Accordingly, we developed the guidance document entitled, ``Guidance for Industry--Oversight of Clinical Investigations: A Risk- Based Approach to Monitoring.'' The guidance is intended to assist sponsors of clinical investigations in developing strategies for risk- based monitoring and plans for clinical investigations of human drug and biological products, medical devices, and combinations thereof. The guidance describes strategies for monitoring activities performed by sponsors or by contract research organizations (CROs) that focus on the conduct, oversight, and reporting of findings of an investigation by clinical investigators. The guidance also recommends strategies that reflect a risk-based approach to monitoring that focuses on critical study parameters and relies on a combination of monitoring activities to oversee a study effectively. Finally, the guidance specifically encourages greater reliance on centralized monitoring methods where appropriate. Information collections for reports and records associated with clinical investigations under parts 312 and 812 are currently approved under OMB control numbers 0910-0014 and 0910-0078 respectively. These reporting and recordkeeping provisions cover general elements. The guidance discusses other elements sponsors and investigators should consider and include in developing a monitoring plan. As explained in the guidance, documentation of monitoring should include sufficient detail to allow verification that the monitoring plan was followed. The plan should provide adequate information to those involved with monitoring to effectively carry out their duties. All sponsor and CRO personnel who may be involved with monitoring (including those who review appropriate action, determine appropriate action, or both) regarding potential issues identified through monitoring should review the monitoring plan. We estimate the burden of this collection of information as follows: Table 1--Estimated Annual Recordkeeping Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average Activity Number of records per Total Annual burden per Total hours recordkeepers recordkeeper Records recordkeeping ---------------------------------------------------------------------------------------------------------------- Documentation included in 88 1.5 132 4 528 comprehensive monitoring plan.. ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Based on a review of the information collection, we have made no adjustments to our burden estimate. We estimate 88 sponsors will develop 132 comprehensive monitoring plans in accordance with the guidance. We believe the associated burden for each plan is approximately 4 hours and includes the time necessary to develop, and amend as appropriate, the monitoring plan. Dated: November 26, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-26032 Filed 11-29-18; 8:45 am] BILLING CODE 4164-01-P
![61646 Federal Register / Vol. 83, No. 231 / Friday, November 30, 2018 / Notices
its consideration of comments. The with the initial submission of an This determination of the regulatory
second copy, which will have the application to market the human drug review period establishes the maximum
claimed confidential information product and continues until FDA grants potential length of a patent extension.
redacted/blacked out, will be available permission to market the drug product. However, the USPTO applies several
for public viewing and posted on Although only a portion of a regulatory statutory limitations in its calculations
https://www.regulations.gov. Submit review period may count toward the of the actual period for patent extension.
both copies to the Dockets Management actual amount of extension that the In its application for patent extension,
Staff. If you do not wish your name and Director of USPTO may award (for this applicant seeks 298 days of patent
contact information to be made publicly example, half the testing phase must be term extension.
available, you can provide this subtracted as well as any time that may
III. Petitions
information on the cover sheet and not have occurred before the patent was
in the body of your comments and you issued), FDA’s determination of the Anyone with knowledge that any of
must identify this information as length of a regulatory review period for the dates as published are incorrect may
‘‘confidential.’’ Any information marked a human drug product will include all submit either electronic or written
as ‘‘confidential’’ will not be disclosed of the testing phase and approval phase comments and, under 21 CFR 60.24, ask
except in accordance with § 10.20 (21 as specified in 35 U.S.C. 156(g)(1)(B). for a redetermination (see DATES).
CFR 10.20) and other applicable FDA has approved for marketing the Furthermore, as specified in § 60.30 (21
disclosure law. For more information human drug product, PROVAYBLUE CFR 60.30), any interested person may
about FDA’s posting of comments to (methylene blue) indicated for the petition FDA for a determination
public dockets, see 80 FR 56469, treatment of pediatric and adult patients regarding whether the applicant for
September 18, 2015, or access the with acquired methemoglobinemia. extension acted with due diligence
information at: https://www.gpo.gov/ Subsequent to this approval, the USPTO during the regulatory review period. To
fdsys/pkg/FR-2015-09-18/pdf/2015- received a patent term restoration meet its burden, the petition must
23389.pdf. application for PROVAYBLUE (U.S. comply with all the requirements of
Docket: For access to the docket to Patent No. 8,765,942) from Provepharm § 60.30, including but not limited to:
read background documents or the S.A.S. and the USPTO requested FDA’s Must be timely (see DATES), must be
electronic and written/paper comments assistance in determining the patent’s filed in accordance with § 10.20, must
received, go to https:// eligibility for patent term restoration. In contain sufficient facts to merit an FDA
www.regulations.gov and insert the a letter dated February 6, 2018, FDA investigation, and must certify that a
docket number, found in brackets in the advised the USPTO that this human true and complete copy of the petition
heading of this document, into the drug product had undergone a has been served upon the patent
‘‘Search’’ box and follow the prompts regulatory review period and that the applicant. (See H. Rept. 857, part 1, 98th
and/or go to the Dockets Management approval of PROVAYBLUE represented Cong., 2d sess., pp. 41–42, 1984.)
Staff, 5630 Fishers Lane, Rm. 1061, the first permitted commercial Petitions should be in the format
Rockville, MD 20852. marketing or use of the product. specified in 21 CFR 10.30.
Thereafter, the USPTO requested that Submit petitions electronically to
FOR FURTHER INFORMATION CONTACT: https://www.regulations.gov at Docket
FDA determine the product’s regulatory
Beverly Friedman, Office of Regulatory No. FDA–2013–S–0610. Submit written
review period.
Policy, Food and Drug Administration, petitions (two copies are required) to the
10903 New Hampshire Ave., Bldg. 51, II. Determination of Regulatory Review Dockets Management Staff (HFA–305),
Rm. 6250, Silver Spring, MD 20993, Period Food and Drug Administration, 5630
301–796–3600. FDA has determined that the Fishers Lane, Rm. 1061, Rockville, MD
SUPPLEMENTARY INFORMATION: applicable regulatory review period for 20852.
I. Background PROVAYBLUE is 415 days. Of this time, Dated: November 26, 2018.
232 days occurred during the testing Leslie Kux,
The Drug Price Competition and phase of the regulatory review period,
Patent Term Restoration Act of 1984 Associate Commissioner for Policy.
while 183 days occurred during the
(Pub. L. 98–417) and the Generic [FR Doc. 2018–26035 Filed 11–29–18; 8:45 am]
approval phase. These periods of time
Animal Drug and Patent Term were derived from the following dates: BILLING CODE 4164–01–P
Restoration Act (Pub. L. 100–670) 1. The date an exemption under
generally provide that a patent may be section 505(i) of the Federal Food, Drug,
extended for a period of up to 5 years and Cosmetic Act (FD&C Act) (21 U.S.C. DEPARTMENT OF HEALTH AND
so long as the patented item (human 355(i)) became effective: February 20, HUMAN SERVICES
drug product, animal drug product, 2015. FDA has verified the applicant’s Food and Drug Administration
medical device, food additive, or color claim that the date the investigational
additive) was subject to regulatory new drug application became effective [Docket No. FDA–2011–D–0597]
review by FDA before the item was was February 20, 2015.
marketed. Under these acts, a product’s 2. The date the application was Agency Information Collection
regulatory review period forms the basis initially submitted with respect to the Activities; Proposed Collection;
for determining the amount of extension human drug product under section Comment Request; Oversight of
an applicant may receive. 505(b) of the FD&C Act: October 9, 2015. Clinical Investigations: A Risk-Based
A regulatory review period consists of FDA has verified the applicant’s claim Approach to Monitoring
amozie on DSK3GDR082PROD with NOTICES1
two periods of time: A testing phase and that the new drug application (NDA) for AGENCY: Food and Drug Administration,
an approval phase. For human drug PROVAYBLUE (NDA 204630) was HHS.
products, the testing phase begins when initially submitted on October 9, 2015. ACTION: Notice.
the exemption to permit the clinical 3. The date the application was
investigations of the drug becomes approved: April 8, 2016. FDA has SUMMARY: The Food and Drug
effective and runs until the approval verified the applicant’s claim that NDA Administration (FDA or Agency) is
phase begins. The approval phase starts 204630 was approved on April 8, 2016. announcing an opportunity for public
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![61648 Federal Register / Vol. 83, No. 231 / Friday, November 30, 2018 / Notices
appropriate oversight of their clinical and biological products, medical recordkeeping provisions cover general
investigations to ensure adequate devices, and combinations thereof. The elements. The guidance discusses other
protection of the rights, welfare, and guidance describes strategies for elements sponsors and investigators
safety of human subjects and to ensure monitoring activities performed by should consider and include in
the quality and integrity of the resulting sponsors or by contract research developing a monitoring plan. As
data submitted to FDA. As part of this organizations (CROs) that focus on the explained in the guidance,
oversight, sponsors of clinical conduct, oversight, and reporting of documentation of monitoring should
investigations are required to monitor findings of an investigation by clinical include sufficient detail to allow
the conduct and progress of their investigators. The guidance also verification that the monitoring plan
clinical investigations. The regulations recommends strategies that reflect a
was followed. The plan should provide
do not specify how sponsors are to risk-based approach to monitoring that
adequate information to those involved
conduct monitoring of clinical focuses on critical study parameters and
investigations and are, therefore, relies on a combination of monitoring with monitoring to effectively carry out
compatible with a range of approaches activities to oversee a study effectively. their duties. All sponsor and CRO
to monitoring. Finally, the guidance specifically personnel who may be involved with
Accordingly, we developed the encourages greater reliance on monitoring (including those who review
guidance document entitled, ‘‘Guidance centralized monitoring methods where appropriate action, determine
for Industry—Oversight of Clinical appropriate. appropriate action, or both) regarding
Investigations: A Risk-Based Approach Information collections for reports potential issues identified through
to Monitoring.’’ The guidance is and records associated with clinical monitoring should review the
intended to assist sponsors of clinical investigations under parts 312 and 812 monitoring plan.
investigations in developing strategies are currently approved under OMB We estimate the burden of this
for risk-based monitoring and plans for control numbers 0910–0014 and 0910– collection of information as follows:
clinical investigations of human drug 0078 respectively. These reporting and
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total Annual
Activity records per burden per Total hours
recordkeepers Records
recordkeeper recordkeeping
Documentation included in comprehensive monitoring plan 88 1.5 132 4 528
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information SUMMARY: The Food and Drug comment will be made public, you are
collection, we have made no Administration (FDA or Agency) is solely responsible for ensuring that your
adjustments to our burden estimate. We announcing the availability of the draft comment does not include any
estimate 88 sponsors will develop 132 guidance for industry and FDA staff confidential information that you or a
comprehensive monitoring plans in entitled ‘‘Blood Glucose Monitoring third party may not wish to be posted,
accordance with the guidance. We Test Systems for Prescription Point-of- such as medical information, your or
believe the associated burden for each Care Use.’’ This draft guidance anyone else’s Social Security number, or
plan is approximately 4 hours and document describes studies and criteria confidential business information, such
includes the time necessary to develop, that FDA recommends be used when as a manufacturing process. Please note
and amend as appropriate, the submitting premarket notifications that if you include your name, contact
monitoring plan. (510(k)s) for blood glucose monitoring information, or other information that
Dated: November 26, 2018. systems (BGMSs) that are for identifies you in the body of your
Leslie Kux,
prescription point-of-care use. This draft comments, that information will be
guidance is not final nor is it in effect posted on https://www.regulations.gov.
Associate Commissioner for Policy.
at this time. • If you want to submit a comment
[FR Doc. 2018–26032 Filed 11–29–18; 8:45 am]
DATES: Submit either electronic or with confidential information that you
BILLING CODE 4164–01–P
written comments on the draft guidance do not wish to be made available to the
by February 28, 2019 to ensure that the public, submit the comment as a
DEPARTMENT OF HEALTH AND Agency considers your comment on this written/paper submission and in the
HUMAN SERVICES draft guidance before it begins work on manner detailed (see ‘‘Written/Paper
the final version of the guidance. Submissions’’ and ‘‘Instructions’’).
Food and Drug Administration ADDRESSES: You may submit comments Written/Paper Submissions
on any guidance at any time as follows:
[Docket No. FDA–2013–D–1445] Submit written/paper submissions as
Electronic Submissions follows:
Blood Glucose Monitoring Test Submit electronic comments in the • Mail/Hand Delivery/Courier (for
Systems for Prescription Point-of-Care following way: written/paper submissions): Dockets
amozie on DSK3GDR082PROD with NOTICES1
Use; Draft Guidance for Industry and • Federal eRulemaking Portal: Management Staff (HFA–305), Food and
Food and Drug Administration Staff; https://www.regulations.gov. Follow the Drug Administration, 5630 Fishers
Availability instructions for submitting comments. Lane, Rm. 1061, Rockville, MD 20852.
AGENCY: Food and Drug Administration, Comments submitted electronically, • For written/paper comments
HHS. including attachments, to https:// submitted to the Dockets Management
www.regulations.gov will be posted to Staff, FDA will post your comment, as
ACTION: Notice of availability.
the docket unchanged. Because your well as any attachments, except for
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Document Created: 2018-11-30 04:35:55
Document Modified: 2018-11-30 04:35:55
| 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 | Submit either electronic or written comments on the collection of information by January 29, 2019. | |
| Contact | Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected] | |
| FR Citation | 83 FR 61646 |
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