Coronary Drug-Eluting Stents-Nonclinical and Clinical Studies and Companion Guidance Document; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Reopening of the Comment Period, 48824-48825 [2018-21041]

Download as PDF 48824 Federal Register / Vol. 83, No. 188 / Thursday, September 27, 2018 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Portion of study Total annual responses Average burden per response Total hours 1 Pre-test ................................................................................. Interviews ............................................................................. 5 339 1 1 5 339 1.5 1.5 7.5 508.5 Total .............................................................................. ........................ ........................ ........................ ........................ 516 1 There are no capital costs or operating and maintenance costs associated with this collection of information. ERG will conduct a pretest of the interview protocol with five respondents. FDA estimates that it will take 1.0 to 1.5 hours to complete the pretest, for a total of a maximum of 7.5 hours. FDA estimates that up to 339 respondents will take part in the interviews each year, with each interview lasting 1.0 to 1.5 hours, for a total of a maximum of 508.5 hours. Thus, the total estimated annual burden is 516 hours. FDA’s burden estimate is based on prior experience with similar interviews with the regulated community. Dated: September 21, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–21038 Filed 9–26–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–D–0180] Coronary Drug-Eluting Stents— Nonclinical and Clinical Studies and Companion Guidance Document; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS. Notice; reopening of the comment period. ACTION: The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice of availability, published in the Federal Register of March 27, 2008. In that document, FDA requested comments on two draft guidance documents entitled ‘‘Coronary DrugEluting Stents—Nonclinical and Clinical Studies’’ and ‘‘Coronary DrugEluting Stents—Nonclinical and Clinical Studies Draft Companion Guidance Document.’’ The Agency is reopening the comment period to allow interested persons to provide updated comments and any new information. SUMMARY: daltland on DSKBBV9HB2PROD with NOTICES Number of responses per respondent VerDate Sep<11>2014 17:20 Sep 26, 2018 Jkt 244001 FDA is reopening the comment period on the notice of availability published March 27, 2008 (73 FR 16311). Submit either electronic or written comments on the draft guidances by December 26, 2018, to ensure that the Agency considers your comment on the draft guidances before it begins work on the final version of the guidances. ADDRESSES: You may submit comments on any guidance at any time as follows: DATES: 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 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2008–D–0180 for ‘‘Coronary DrugEluting Stents—Nonclinical and Clinical Studies’’ and ‘‘Coronary DrugEluting Stents—Nonclinical and Clinical Studies Draft Companion Guidance Document.’’ 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/201523389.pdf. Docket: For access to the docket to read background documents or the E:\FR\FM\27SEN1.SGM 27SEN1 Federal Register / Vol. 83, No. 188 / Thursday, September 27, 2018 / Notices 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)). An electronic copy of the guidance documents is available for download from the internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidances. Submit written requests for a single hard copy of the draft guidance documents entitled ‘‘Coronary DrugEluting Stents—Nonclinical and Clinical Studies’’ and ‘‘Coronary DrugEluting Stents—Nonclinical and Clinical Studies Draft Companion Guidance Document’’ to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993–0002. Send one selfaddressed adhesive label to assist that office in processing your request. FOR FURTHER INFORMATION CONTACT: Michael John, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1224, Silver Spring, MD 20993–0002, 301–796–6329, Michael.John@fda.hhs.gov or Kimberly Peters, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4314, Silver Spring, MD 20993–0002, 301–796–6350, Kimberly.Peters@fda.hhs.gov. SUPPLEMENTARY INFORMATION: daltland on DSKBBV9HB2PROD with NOTICES I. Background In the Federal Register of March 27, 2008, FDA published a notice of availability with a 120-day comment period to request comments on the draft guidances entitled ‘‘Coronary DrugEluting Stents—Nonclinical and Clinical Studies’’ and ‘‘Coronary DrugEluting Stents—Nonclinical and Clinical Studies Draft Companion Guidance Document.’’ The draft guidances are being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidances, when finalized, will represent the current thinking of FDA on coronary drug-eluting stents— nonclinical and clinical studies. They do not establish any rights for any person and are not binding on FDA or VerDate Sep<11>2014 17:20 Sep 26, 2018 Jkt 244001 the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. The guidances are not subject to Executive Order 12866. FDA is reopening the comment period to consider any new information and intends to issue revised versions of these draft guidances for further consideration. This action will help the Center for Devices and Radiological Health fulfill its commitment to finalize, withdraw, or reopen the comment period for 50 percent of existing draft guidances issued prior to October 1, 2012 (82 FR 58429, December 12, 2017). FDA is reopening the comment period for 90 days. The Agency believes that a 90-day extension allows adequate time for interested parties to submit comments. Previously submitted comments do not need to be resubmitted for consideration. II. Electronic Access Persons interested in obtaining a copy of the draft guidances may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. The draft guidance documents are also available at https:// www.regulations.gov. Persons unable to download an electronic copy of ‘‘Coronary Drug-Eluting Stents— Nonclinical and Clinical Studies’’ and ‘‘Coronary Drug-Eluting Stents— Nonclinical and Clinical Studies Draft Companion Guidance Document’’ may send an email request to CDRHGuidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 6255 to identify the guidance you are requesting. Dated: September 21, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–21041 Filed 9–26–18; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 48825 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–D–1752] Public Availability of Lists of Retail Consignees To Effectuate Certain Human and Animal Food Recalls; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled ‘‘Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls.’’ The draft guidance, when finalized, establishes guidance for industry and FDA staff on how and when FDA intends to collect, compile, and publicize retail consignees that may have received recalled foods. While FDA intends to focus on recalls where there is a reasonable probability that the use of, or exposure to, the food will cause serious adverse health consequences or death to humans or animals (Class I recalls), FDA may also publicize retail consignee lists for other food recalls as described in the draft guidance. FDA’s goal is to publicize retail consignee lists for these food recalls where providing this additional information will be of the most use to consumers to help them identify recalled food and to determine whether that food is in their possession as effectively and quickly as possible. DATES: Submit either electronic or written comments on the draft guidance by November 26, 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 as follows: SUMMARY: 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, E:\FR\FM\27SEN1.SGM 27SEN1

Agencies

[Federal Register Volume 83, Number 188 (Thursday, September 27, 2018)]
[Notices]
[Pages 48824-48825]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21041]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0180]


Coronary Drug-Eluting Stents--Nonclinical and Clinical Studies 
and Companion Guidance Document; Draft Guidance for Industry and Food 
and Drug Administration Staff; Availability; Reopening of the Comment 
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of the comment period.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
reopening the comment period for the notice of availability, published 
in the Federal Register of March 27, 2008. In that document, FDA 
requested comments on two draft guidance documents entitled ``Coronary 
Drug-Eluting Stents--Nonclinical and Clinical Studies'' and ``Coronary 
Drug-Eluting Stents--Nonclinical and Clinical Studies Draft Companion 
Guidance Document.'' The Agency is reopening the comment period to 
allow interested persons to provide updated comments and any new 
information.

DATES: FDA is reopening the comment period on the notice of 
availability published March 27, 2008 (73 FR 16311). Submit either 
electronic or written comments on the draft guidances by December 26, 
2018, to ensure that the Agency considers your comment on the draft 
guidances before it begins work on the final version of the guidances.

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-2008-D-0180 for ``Coronary Drug-Eluting Stents--Nonclinical and 
Clinical Studies'' and ``Coronary Drug-Eluting Stents--Nonclinical and 
Clinical Studies Draft Companion Guidance Document.'' 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

[[Page 48825]]

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)).
    An electronic copy of the guidance documents is available for 
download from the internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidances. Submit written 
requests for a single hard copy of the draft guidance documents 
entitled ``Coronary Drug-Eluting Stents--Nonclinical and Clinical 
Studies'' and ``Coronary Drug-Eluting Stents--Nonclinical and Clinical 
Studies Draft Companion Guidance Document'' to the Office of the Center 
Director, Guidance and Policy Development, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your 
request.

FOR FURTHER INFORMATION CONTACT: Michael John, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1224, Silver Spring, MD 20993-0002, 301-796-6329, 
[email protected] or Kimberly Peters, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 4314, Silver Spring, MD 20993-0002, 301-796-6350, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of March 27, 2008, FDA published a notice 
of availability with a 120-day comment period to request comments on 
the draft guidances entitled ``Coronary Drug-Eluting Stents--
Nonclinical and Clinical Studies'' and ``Coronary Drug-Eluting Stents--
Nonclinical and Clinical Studies Draft Companion Guidance Document.''
    The draft guidances are being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidances, 
when finalized, will represent the current thinking of FDA on coronary 
drug-eluting stents--nonclinical and clinical studies. They do not 
establish any rights for any person and are not binding on FDA or the 
public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations. The guidances 
are not subject to Executive Order 12866.
    FDA is reopening the comment period to consider any new information 
and intends to issue revised versions of these draft guidances for 
further consideration. This action will help the Center for Devices and 
Radiological Health fulfill its commitment to finalize, withdraw, or 
reopen the comment period for 50 percent of existing draft guidances 
issued prior to October 1, 2012 (82 FR 58429, December 12, 2017).
    FDA is reopening the comment period for 90 days. The Agency 
believes that a 90-day extension allows adequate time for interested 
parties to submit comments. Previously submitted comments do not need 
to be resubmitted for consideration.

II. Electronic Access

    Persons interested in obtaining a copy of the draft guidances may 
do so by downloading an electronic copy from the internet. A search 
capability for all Center for Devices and Radiological Health guidance 
documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. The draft 
guidance documents are also available at https://www.regulations.gov. 
Persons unable to download an electronic copy of ``Coronary Drug-
Eluting Stents--Nonclinical and Clinical Studies'' and ``Coronary Drug-
Eluting Stents--Nonclinical and Clinical Studies Draft Companion 
Guidance Document'' may send an email request to [email protected] to receive an electronic copy of the document. 
Please use the document number 6255 to identify the guidance you are 
requesting.

    Dated: September 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21041 Filed 9-26-18; 8:45 am]
BILLING CODE 4164-01-P

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