Gastroparesis: Clinical Evaluation of Drugs for Treatment; Draft Guidance for Industry; Availability, 40423-40424 [2019-17463]

Download as PDF 40423 Federal Register / Vol. 84, No. 157 / Wednesday, August 14, 2019 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued Number of responses per respondent Number of respondents 21 CFR section Total annual responses Average burden per response Total hours 56.113; suspension of research .................................. 56.120(a); IRB response to lesser administration actions for noncompliance. 56.123; reinstatement of an IRB or an institution. ...... 2,520 7 1 1 2,520 7 0.5 (30 minutes) ..... 10 ........................... 1,260 70 1 1 1 5 ............................. 5 Total ...................................................................... ........................ ........................ ........................ ................................ 155,079 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Based on a review of data, there are currently 2,520 IRBs overseeing FDAregulated clinical research. We have revised the table to list only one requirement per row, rather than estimating the combination of several requirements. The estimated burden resulted in an increase from 1 hour to 1.5 hours when these combined requirements were estimated separately. We believe this is a more accurate measure of the cumulative time necessary for these activities. We invite comment on this estimate. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers 21 CFR part; activity 56.115; IRB records ............................................................. 1 There Number of records per recordkeeper 2,520 Total annual records 14.6 Average burden per recordkeeping 36,792 40 Total hours 1,471,680 are no capital or operating and maintenance costs associated with the information collection. We assume each of the 2,520 IRBs meets an average of 14.6 times annually and that approximately 40 hours of person-time per meeting are required to meet the requirements of the regulation. We have reduced the average burden per record from 100 hours to 40 hours because we believe the original estimate of 100 hours has decreased with the use of electronic recordkeeping and new technologies available to maintain records. We request comments on this revision. TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 56.109(g) IRB written statement about public disclosures to sponsor of emergency research under 50.24 .............. jspears on DSK3GMQ082PROD with NOTICES 1 There Number of disclosures per respondent Number of respondents 21 CFR section 8 Total annual disclosures 2 16 Average burden per disclosure Total hours 1 16 are no capital costs or operating and maintenance costs associated with this collection of information. For the third-party disclosure burden, we estimate that eight IRBs per year will receive a request to review emergency research under § 50.24. We estimate that it will take an IRB approximately 1 hour to prepare each written statement, for a total of 2 hours per study. The total annual third-party disclosure burden for IRBs to fulfill this requirement is estimated at 16 hours. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: August 6, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. HHS. [FR Doc. 2019–17462 Filed 8–13–19; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 18:56 Aug 13, 2019 Jkt 247001 Food and Drug Administration [Docket No. FDA–2015–D–2479] Gastroparesis: Clinical Evaluation of Drugs for Treatment; Draft Guidance for Industry; Availability AGENCY: ACTION: Food and Drug Administration, Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘Gastroparesis: Clinical Evaluation of Drugs for Treatment.’’ This draft guidance is intended to provide the FDA’s current thinking regarding SUMMARY: PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 clinical trial design and clinical endpoint assessments to support development of drugs for the treatment of diabetic and idiopathic gastroparesis. This draft guidance replaces the draft guidance for industry of the same name issued July 23, 2015. DATES: Submit either electronic or written comments on the draft guidance by October 15, 2019 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. E:\FR\FM\14AUN1.SGM 14AUN1 40424 Federal Register / Vol. 84, No. 157 / Wednesday, August 14, 2019 / Notices jspears on DSK3GMQ082PROD with NOTICES 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– 2015–D–2479 for ‘‘Gastroparesis: Clinical Evaluation of Drugs for Treatment.’’ 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 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 VerDate Sep<11>2014 18:56 Aug 13, 2019 Jkt 247001 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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. 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: Juli Tomaino, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5373, Silver Spring, MD 20993–0002, 301–796–8812. SUPPLEMENTARY INFORMATION: thinking on the development of clinical outcome assessment tools and statistical considerations for use of those tools as a measure of the primary and secondary efficacy endpoints. 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 FDA’s current thinking of FDA on ‘‘Gastroparesis: Clinical Evaluation of Drugs for Treatment.’’ 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. I. Background Child-Resistant Packaging Statements in Drug Product Labeling; Guidance for Industry; Availability FDA is announcing the availability of a draft guidance for industry entitled ‘‘Gastroparesis: Clinical Evaluation of Drugs for Treatment.’’ The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of diabetic and idiopathic gastroparesis. This draft guidance replaces the draft guidance for industry of the same name issued July 23, 2015 (80 FR 43781). This draft was updated to address public comments received in 2015 and to reflect FDA’s current PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 II. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in 21 CFR parts 312 and 314 have been approved under OMB control numbers 0910–0014 and 0910– 0001, respectively. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs or https:// www.regulations.gov. Dated: August 8, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–17463 Filed 8–13–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–D–2163] AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ‘‘ChildResistant Packaging Statements in Drug Product Labeling.’’ This guidance is intended to assist applicants, SUMMARY: E:\FR\FM\14AUN1.SGM 14AUN1

Agencies

[Federal Register Volume 84, Number 157 (Wednesday, August 14, 2019)]
[Notices]
[Pages 40423-40424]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17463]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-2479]


Gastroparesis: Clinical Evaluation of Drugs for Treatment; Draft 
Guidance for Industry; 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 
``Gastroparesis: Clinical Evaluation of Drugs for Treatment.'' This 
draft guidance is intended to provide the FDA's current thinking 
regarding clinical trial design and clinical endpoint assessments to 
support development of drugs for the treatment of diabetic and 
idiopathic gastroparesis. This draft guidance replaces the draft 
guidance for industry of the same name issued July 23, 2015.

DATES: Submit either electronic or written comments on the draft 
guidance by October 15, 2019 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.

[[Page 40424]]

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-2015-D-2479 for ``Gastroparesis: Clinical Evaluation of Drugs for 
Treatment.'' 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 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.gpo.gov/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. 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: Juli Tomaino, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 5373, Silver Spring, MD 20993-0002, 301-
796-8812.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Gastroparesis: Clinical Evaluation of Drugs for Treatment.'' 
The purpose of this draft guidance is to assist sponsors in the 
clinical development of drugs for the treatment of diabetic and 
idiopathic gastroparesis. This draft guidance replaces the draft 
guidance for industry of the same name issued July 23, 2015 (80 FR 
43781). This draft was updated to address public comments received in 
2015 and to reflect FDA's current thinking on the development of 
clinical outcome assessment tools and statistical considerations for 
use of those tools as a measure of the primary and secondary efficacy 
endpoints.
    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 FDA's current thinking of FDA on 
``Gastroparesis: Clinical Evaluation of Drugs for Treatment.'' 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. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR parts 312 and 314 have been 
approved under OMB control numbers 0910-0014 and 0910-0001, 
respectively.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs or https://www.regulations.gov.

    Dated: August 8, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-17463 Filed 8-13-19; 8:45 am]
 BILLING CODE 4164-01-P
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