83 FR 25015 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 105 (May 31, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 105 (May 31, 2018)
| Page Range | 25015-25018 | |
| FR Document | 2018-11647 |
[Federal Register Volume 83, Number 105 (Thursday, May 31, 2018)] [Notices] [Pages 25015-25018] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-11647] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0908] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public 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 [[Page 25016]] solicits comments on the collection of information concerning the establishment and operation of clinical trial data monitoring committees. DATES: Submit either electronic or written comments on the collection of information by July 30, 2018. 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 July 30, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of July 30, 2018. 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-N-0908 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees.'' 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: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, PRAStaff@fda.hhs.gov. 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. Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees OMB Control Number 0910-0581--Extension Sponsors are required to monitor studies evaluating new drugs, biologics, and devices (21 CFR 312.50 and 312.56 for drugs and biologics, and 21 CFR 812.40 and 812.46 for devices). Various individuals and groups play different roles in clinical trial monitoring. One such group is a data monitoring committee (DMC), appointed by a sponsor to evaluate the accumulating outcome data in some trials. A clinical trial DMC is a group of individuals with [[Page 25017]] pertinent expertise that reviews on a regular basis accumulating data from one or more ongoing clinical trials. The DMC advises the sponsor regarding the continuing safety of current trial subjects and those yet to be recruited to the trial, as well as the continuing validity and scientific merit of the trial. The guidance document referenced in this document is intended to assist sponsors of clinical trials in determining when a DMC is needed for monitoring a study and how such committees should operate. The guidance addresses the roles, responsibilities, and operating procedures of DMCs and describes certain reporting and recordkeeping responsibilities, including the following: (1) Sponsor reporting to FDA on DMC recommendations related to safety; (2) standard operating procedures (SOPs) for DMCs; (3) DMC meeting records; (4) sponsor notification to the DMC regarding waivers; and (5) DMC reports based on meeting minutes to the sponsor. 1. Sponsor Reporting to FDA on DMC Recommendations Related to Safety The requirement of the sponsor to report DMC recommendations related to serious adverse events in an expedited manner in clinical trials of new drugs (Sec. 312.32(c) (21 CFR 312.32(c))) would not apply when the DMC recommendation is related to an excess of events not classifiable as serious. Nevertheless, the Agency recommends in the guidance that sponsors inform FDA about all recommendations related to the safety of the investigational product whether or not the adverse event in question meets the definition of ``serious.'' 2. SOPs for DMCs In the guidance, FDA recommends that sponsors establish procedures to do the following things: Assess potential conflicts of interest of proposed DMC members; Ensure that those with serious conflicts of interest are not included in the DMC; Provide disclosure to all DMC members of any potential conflicts that are not thought to impede objectivity and, thus, would not preclude service on the DMC; Identify and disclose any concurrent service of any DMC member on other DMCs of the same, related, or competing products; Ensure separation, and designate a different statistician to advise on the management of the trial, if the primary trial statistician takes on the responsibility for interim analysis and reporting to the DMC; and Minimize the risks of bias that are associated with an arrangement under which the primary trial statistician takes on the responsibility for interim analysis and reporting to the DMC, if it appears infeasible or highly impractical for any other statistician to take over responsibilities related to trial management. 3. DMC Meeting Records The Agency recommends in the guidance that the DMC or the group preparing the interim reports to the DMC maintain all meeting records. This information should be submitted to FDA with the clinical study report (21 CFR 314.50(d)(5)(ii)). 4. Sponsor Notification to the DMC Regarding Waivers The sponsor must report to FDA certain serious and unexpected adverse events in drugs and biologics trials (Sec. 312.32) and unanticipated adverse device effects in the case of device trials (21 CFR 812.150(b)(1)). The Agency recommends in the guidance that sponsors notify DMCs about any waivers granted by FDA for expedited reporting of certain serious events. 5. DMC Reports of Meeting Minutes to the Sponsor The Agency recommends in the guidance that DMCs should issue a written report to the sponsor based on the DMC meeting minutes. Reports to the sponsor should include only those data generally available to the sponsor. The sponsor may convey the relevant information in this report to other interested parties, such as study investigators. Meeting minutes or other information that include discussion of confidential data would not be provided to the sponsor. Description of the Respondents: The submission and data collection recommendations described in this document affect sponsors of clinical trials and DMCs. Burden Estimate: Table 1 of this document provides the burden estimate of the annual reporting burden for the information to be submitted in accordance with the guidance. Table 2 of this document provides the burden estimate of the annual recordkeeping burden for the information to be maintained in accordance with the guidance. Table 3 of this document provides the burden estimate of the annual third-party disclosure burden for the information to be submitted in accordance with the guidance. Reporting, Recordkeeping, and Third-Party Disclosure Burdens: Based on information from FDA review divisions, FDA estimates there are approximately 740 clinical trials with DMCs regulated by the Center for Biologics Evaluation and Research, the Center for Drug Evaluation and Research, and the Center for Devices and Radiological Health. FDA estimates that the average length of a clinical trial is 2 years, resulting in an annual estimate of 370 clinical trials. Because FDA has no information on which to project a change in the use of DMCs, FDA estimates that the number of clinical trials with DMCs will not change significantly. For purposes of this information collection, FDA estimates that each sponsor is responsible for approximately 10 trials, resulting in an estimated 37 sponsors that are affected by the guidance annually. Based on information provided to FDA by sponsors that have typically used DMCs for the kinds of studies for which this guidance recommends them, FDA estimates that the majority of sponsors have already prepared SOPs for DMCs, and only a minimum amount of time is necessary to revise or update them for use for other clinical studies. FDA receives very few requests for waivers regarding expedited reporting of certain serious events; therefore, FDA has estimated one respondent per year to account for the rare instance a request may be made. Based on FDA's experience with clinical trials using DMCs, FDA estimates that the sponsor on average would issue two interim reports per clinical trial to the DMC. FDA estimates that the DMCs would hold two meetings per year per clinical trial resulting in the issuance of two DMC reports of meeting minutes to the sponsor. One set of both of the meeting records should be maintained per clinical trial. The ``Average Burden per Response'' and ``Average Burden per Recordkeeping'' are based on FDA's experience with comparable recordkeeping and reporting provisions applicable to FDA regulated industry. The ``Average Burden per Response'' includes the time the respondent would spend reviewing, gathering, and preparing the information to be submitted to the DMC, FDA, or the sponsor. The ``Average Burden per Recordkeeping'' includes the time to record, gather, and maintain the information. The information collection provisions in the guidance for 21 CFR 312.30, 312.32, 312.38, 312.55, and 312.56 have been approved under OMB control number 0910-0014; 21 CFR 314.50 has been approved under OMB control number 0910-0001; and 21 CFR 812.35 [[Page 25018]] and 812.150 have been approved under OMB control number 0910-0078. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Section of guidance/reporting activity Number of responses per Total annual Average burden per response Total hours respondents respondent responses -------------------------------------------------------------------------------------------------------------------------------------------------------- 5. Sponsor reporting to FDA on DMC 37 1 37 0.50 (30 minutes)...................... 18.5 recommendations related to safety. -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Table 2--Estimated Annual Recordkeeping Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Section of guidance/recordkeeping activity Number of records per Total annual Average burden per recordkeeping Total hours recordkeepers recordkeeper records -------------------------------------------------------------------------------------------------------------------------------------------------------- 4.1. and 6.4 SOPs for DMCs..................... 37 1 37 8...................................... 296 4.4.3.2. DMC meeting records................... 370 1 370 2...................................... 740 rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr Total...................................... .............. .............. .............. ....................................... 1,036 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Table 3--Estimated Annual Third-Party Disclosure Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Section of guidance/disclosure activity Number of disclosures Total annual Average burden per disclosure Total hours respondents per respondent disclosures -------------------------------------------------------------------------------------------------------------------------------------------------------- 4.4.1.2. Sponsor notification to the DMC 1 1 1 0.25 (15 minutes)...................... 0.25 regarding waivers. 4.4.3.2. DMC reports of meeting minutes to the 370 2 740 1...................................... 740 sponsor. -------------------------------------------------------------------------------------------------------- Total...................................... .............. .............. .............. ....................................... 740.25 -------------------------------------------------------------------------------------------------------------------------------------------------------- \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 since our last request for OMB approval, we have made no adjustments to our burden estimate. Dated: May 24, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-11647 Filed 5-30-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 105 / Thursday, May 31, 2018 / Notices 25015
An electronic copy of the guidance applications, HDE applications, 510(k) You can use an alternative approach if
document is available for download submissions, IDE applications, and De it satisfies the requirements of the
from the internet. See the Novo classification requests). applicable statutes and regulations. This
SUPPLEMENTARY INFORMATION section for Non-clinical bench performance guidance is not subject to Executive
information on electronic access to the testing is defined as performance testing Order 12866.
guidance. Submit written requests for a that encompasses all bench testing and
will be dependent upon the specifics of III. Electronic Access
single hard copy of the draft guidance
document entitled ‘‘Recommended the actual device or device type. Non- Persons interested in obtaining a copy
Content and Format of Complete Test clinical bench performance testing of the draft guidance may do so by
Reports for Non-Clinical Bench includes, but is not limited to, downloading an electronic copy from
Performance Testing in Premarket mechanical and biological engineering the internet. A search capability for all
Submissions’’ to the Office of the Center performance such as fatigue, wear, Center for Devices and Radiological
Director, Guidance and Policy tensile strength, compression, and burst Health guidance documents is available
Development, Center for Devices and pressure; bench tests using animal or at https://www.fda.gov/MedicalDevices/
Radiological Health, Food and Drug human tissue; and animal carcass or DeviceRegulationandGuidance/
Administration, 10903 New Hampshire human cadaveric testing. Non-clinical GuidanceDocuments/default.htm. This
Ave., Bldg. 66, Rm. 5431, Silver Spring, bench performance testing excludes guidance document is also available at
MD 20993–0002. Send one self- biocompatibility evaluation, https://www.regulations.gov. Persons
addressed adhesive label to assist that sterilization, and animal in vivo unable to download an electronic copy
office in processing your request. evaluation. of ‘‘Recommended Content and Format
This draft guidance is intended to
FOR FURTHER INFORMATION CONTACT: of Complete Test Reports for Non-
help ensure that clear and consistent
Mary Wen, Center for Devices and Clinical Bench Performance Testing in
information is provided in premarket
Radiological Health, Food and Drug Premarket Submissions’’ may send an
submissions containing non-clinical
Administration, 10903 New Hampshire bench performance testing. The email request to CDRH-Guidance@
Ave., Bldg. 66, Rm. 1529, Silver Spring, information in this draft guidance is fda.hhs.gov to receive an electronic
MD 20993–0002, 240–402–4913. intended to be used in conjunction with copy of the document. Please use the
SUPPLEMENTARY INFORMATION: other FDA guidance documents, document number 18011 to identify the
including device-specific guidances. guidance you are requesting.
I. Background
II. Significance of Guidance IV. Paperwork Reduction Act of 1995
FDA is announcing the availability of
a draft guidance for industry and FDA This draft guidance is being issued This draft guidance refers to
staff entitled ‘‘Recommended Content consistent with FDA’s good guidance previously approved collections of
and Format of Complete Test Reports for practices regulation (21 CFR 10.115). information found in FDA regulations.
Non-Clinical Bench Performance The draft guidance, when finalized, will These collections of information are
Testing in Premarket Submissions.’’ represent the current thinking of FDA subject to review by the Office of
FDA has developed this document to on ‘‘Recommended Content and Format Management and Budget (OMB) under
describe relevant information that of Complete Test Reports for Non- the Paperwork Reduction Act of 1995
should be included in complete test Clinical Bench Performance Testing in (44 U.S.C. 3501–3520). The collections
reports for non-clinical bench Premarket Submissions.’’ It does not of information in the following FDA
performance testing provided in a establish any rights for any person and regulations and guidances have been
premarket submission (i.e., PMA is not binding on FDA or the public. approved by OMB as listed:
OMB control
21 CFR part or guidance Topic No.
807, Subpart E ........................................................................... Premarket Notification ................................................................ 0910–0120
814, Subparts A Through E ....................................................... Premarket Approval .................................................................... 0910–0231
814, Subpart H ........................................................................... Humanitarian Device Exemption ................................................ 0910–0332
812 .............................................................................................. Investigational Device Exemption .............................................. 0910–0078
De Novo Classification Process (Evaluation of Automatic Class De Novo Classification process ................................................. 0910–0844
III Designation).
Dated: May 24, 2018. DEPARTMENT OF HEALTH AND ACTION: Notice.
Leslie Kux, HUMAN SERVICES
SUMMARY: The Food and Drug
Associate Commissioner for Policy. Administration (FDA or Agency) is
Food and Drug Administration
[FR Doc. 2018–11603 Filed 5–30–18; 8:45 am] announcing an opportunity for public
BILLING CODE 4164–01–P comment on the proposed collection of
[Docket No. FDA–2011–N–0908]
certain information by the Agency.
Agency Information Collection Under the Paperwork Reduction Act of
Activities; Proposed Collection; 1995 (PRA), Federal Agencies are
amozie on DSK3GDR082PROD with NOTICES1
Comment Request; Guidance for required to publish notice in the
Clinical Trial Sponsors: Establishment Federal Register concerning each
and Operation of Clinical Trial Data proposed collection of information,
Monitoring Committees including each proposed extension of an
existing collection of information, and
AGENCY: Food and Drug Administration, to allow 60 days for public comment in
HHS. response to the notice. This notice
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![25018 Federal Register / Vol. 83, No. 105 / Thursday, May 31, 2018 / Notices
and 812.150 have been approved under FDA estimates the burden of this
OMB control number 0910–0078. collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Section of guidance/reporting activity responses per burden per Total hours
respondents responses
respondent response
5. Sponsor reporting to FDA on DMC recommendations related to safety .. 37 1 37 0.50 (30 minutes) 18.5
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
Section of guidance/recordkeeping activity records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping
4.1. and 6.4 SOPs for DMCs ......................................................................... 37 1 37 8 ........................... 296
4.4.3.2. DMC meeting records ....................................................................... 370 1 370 2 ........................... 740
Total ........................................................................................................ ........................ ........................ ........................ ............................... 1,036
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number of disclosures Total annual
Section of guidance/disclosure activity burden per Total hours
respondents per respond- disclosures disclosure
ent
4.4.1.2. Sponsor notification to the DMC regarding waivers ......................... 1 1 1 0.25 (15 minutes) 0.25
4.4.3.2. DMC reports of meeting minutes to the sponsor ............................. 370 2 740 1 ........................... 740
Total ........................................................................................................ ........................ ........................ ........................ ............................... 740.25
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information prepared under the auspices of the confidential information that you or a
collection since our last request for International Council for Harmonisation third party may not wish to be posted,
OMB approval, we have made no (ICH), formerly the International such as medical information, your or
adjustments to our burden estimate. Conference on Harmonisation. The draft anyone else’s Social Security number, or
Dated: May 24, 2018. guidance, which consists of a Core confidential business information, such
Leslie Kux, Guideline and an Annex, provides a as a manufacturing process. Please note
Associate Commissioner for Policy.
framework to facilitate the management that if you include your name, contact
of post-approval chemistry, information, or other information that
[FR Doc. 2018–11647 Filed 5–30–18; 8:45 am]
manufacturing, and controls changes for identifies you in the body of your
BILLING CODE 4164–01–P
new and marketed pharmaceutical drug comments, that information will be
substances and drug products, including posted on https://www.regulations.gov.
marketed chemical and • If you want to submit a comment
DEPARTMENT OF HEALTH AND
biotechnological/biological products. with confidential information that you
HUMAN SERVICES
DATES: Submit either electronic or do not wish to be made available to the
Food and Drug Administration written comments on the draft guidance public, submit the comment as a
by December 15, 2018, to ensure that the written/paper submission and in the
[Docket No. FDA–2018–D–1609] manner detailed (see ‘‘Written/Paper
Agency considers your comment on this
draft guidance before it begins work on Submissions’’ and ‘‘Instructions’’).
Q12 Technical and Regulatory
Considerations for Pharmaceutical the final version of the guidance. Written/Paper Submissions
Product Lifecycle Management; ADDRESSES: You may submit comments Submit written/paper submissions as
International Council for on any guidance at any time as follows: follows:
Harmonisation; Draft Guidance for • Mail/Hand delivery/Courier (for
Industry; Availability Electronic Submissions
written/paper submissions): Dockets
AGENCY: Food and Drug Administration, Submit electronic comments in the Management Staff (HFA–305), Food and
HHS. following way: Drug Administration, 5630 Fishers
ACTION: Notice of availability. • Federal eRulemaking Portal: Lane, Rm. 1061, Rockville, MD 20852.
https://www.regulations.gov. Follow the • For written/paper comments
SUMMARY: The Food and Drug instructions for submitting comments. submitted to the Dockets Management
amozie on DSK3GDR082PROD with NOTICES1
Administration (FDA or Agency) is Comments submitted electronically, Staff, FDA will post your comment, as
announcing the availability of a including attachments, to https:// well as any attachments, except for
guidance entitled ‘‘Q12 Technical and www.regulations.gov will be posted to information submitted, marked and
Regulatory Considerations for the docket unchanged. Because your identified, as confidential, if submitted
Pharmaceutical Product Lifecycle comment will be made public, you are as detailed in ‘‘Instructions.’’
Management; International Council for solely responsible for ensuring that your Instructions: All submissions received
Harmonisation.’’ The draft guidance was comment does not include any must include the Docket No. FDA–
VerDate Sep<11>2014 17:46 May 30, 2018 Jkt 241001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\31MYN1.SGM 31MYN1](https://thefederalregister.org/doc/83_FR_25120/page/4.svg)
Document Created: 2018-05-31 00:48:10
Document Modified: 2018-05-31 00:48:10
| 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 July 30, 2018. | |
| Contact | Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected] | |
| FR Citation | 83 FR 25015 |
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