83 FR 48824 - Coronary Drug-Eluting Stents-Nonclinical and Clinical Studies and Companion Guidance Document; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Reopening of the Comment Period
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 188 (September 27, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 188 (September 27, 2018)
| Page Range | 48824-48825 | |
| FR Document | 2018-21041 |
[Federal Register Volume 83, Number 188 (Thursday, September 27, 2018)] [Notices] [Pages 48824-48825] From the Federal Register Online [www.thefederalregister.org] [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No. FDA-2008-D-0180] Coronary Drug-Eluting Stents--Nonclinical and Clinical Studies and Companion Guidance Document; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS.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 In that document, FDA requested comments on two draft guidance documents entitled ``Coronary Drug-Eluting Stents--Nonclinical and Clinical Studies'' and ``Coronary Drug-Eluting Stents--Nonclinical and Clinical Studies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.thefederalregister.org/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
![48824 Federal Register / Vol. 83, No. 188 / Thursday, September 27, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Portion of study responses per burden per Total hours 1
respondents responses
respondent response
Pre-test ................................................................................. 5 1 5 1.5 7.5
Interviews ............................................................................. 339 1 339 1.5 508.5
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 DATES: FDA is reopening the comment information submitted, marked and
interview protocol with five period on the notice of availability identified, as confidential, if submitted
respondents. FDA estimates that it will published March 27, 2008 (73 FR as detailed in ‘‘Instructions.’’
take 1.0 to 1.5 hours to complete the 16311). Submit either electronic or Instructions: All submissions received
pretest, for a total of a maximum of 7.5 written comments on the draft must include the Docket No. FDA–
hours. FDA estimates that up to 339 guidances by December 26, 2018, to 2008–D–0180 for ‘‘Coronary Drug-
respondents will take part in the ensure that the Agency considers your Eluting Stents—Nonclinical and
interviews each year, with each comment on the draft guidances before Clinical Studies’’ and ‘‘Coronary Drug-
interview lasting 1.0 to 1.5 hours, for a it begins work on the final version of the Eluting Stents—Nonclinical and
total of a maximum of 508.5 hours. guidances. Clinical Studies Draft Companion
Thus, the total estimated annual burden ADDRESSES: You may submit comments Guidance Document.’’ Received
is 516 hours. FDA’s burden estimate is on any guidance at any time as follows: comments will be placed in the docket
based on prior experience with similar and, except for those submitted as
Electronic Submissions
interviews with the regulated ‘‘Confidential Submissions,’’ publicly
community. Submit electronic comments in the viewable at https://www.regulations.gov
following way: or at the Dockets Management Staff
Dated: September 21, 2018.
• Federal eRulemaking Portal: between 9 a.m. and 4 p.m., Monday
Leslie Kux, https://www.regulations.gov. Follow the through Friday.
Associate Commissioner for Policy. instructions for submitting comments. • Confidential Submissions—To
[FR Doc. 2018–21038 Filed 9–26–18; 8:45 am] Comments submitted electronically, submit a comment with confidential
BILLING CODE 4164–01–P including attachments, to https:// information that you do not wish to be
www.regulations.gov will be posted to made publicly available, submit your
the docket unchanged. Because your comments only as a written/paper
DEPARTMENT OF HEALTH AND comment will be made public, you are submission. You should submit two
HUMAN SERVICES solely responsible for ensuring that your copies total. One copy will include the
comment does not include any information you claim to be confidential
Food and Drug Administration confidential information that you or a with a heading or cover note that states
[Docket No. FDA–2008–D–0180] third party may not wish to be posted, ‘‘THIS DOCUMENT CONTAINS
such as medical information, your or CONFIDENTIAL INFORMATION.’’ The
Coronary Drug-Eluting Stents— anyone else’s Social Security number, or Agency will review this copy, including
Nonclinical and Clinical Studies and confidential business information, such the claimed confidential information, in
Companion Guidance Document; Draft as a manufacturing process. Please note its consideration of comments. The
Guidance for Industry and Food and that if you include your name, contact second copy, which will have the
Drug Administration Staff; Availability; information, or other information that
claimed confidential information
Reopening of the Comment Period identifies you in the body of your
redacted/blacked out, will be available
comments, that information will be
AGENCY: Food and Drug Administration, for public viewing and posted on
posted on https://www.regulations.gov.
HHS. • If you want to submit a comment https://www.regulations.gov. Submit
Notice; reopening of the
ACTION: with confidential information that you both copies to the Dockets Management
comment period. do not wish to be made available to the Staff. If you do not wish your name and
public, submit the comment as a contact information to be made publicly
SUMMARY: The Food and Drug written/paper submission and in the available, you can provide this
Administration (FDA or the Agency) is manner detailed (see ‘‘Written/Paper information on the cover sheet and not
reopening the comment period for the Submissions’’ and ‘‘Instructions’’). in the body of your comments and you
notice of availability, published in the must identify this information as
Federal Register of March 27, 2008. In Written/Paper Submissions ‘‘confidential.’’ Any information marked
that document, FDA requested Submit written/paper submissions as as ‘‘confidential’’ will not be disclosed
comments on two draft guidance follows: except in accordance with 21 CFR 10.20
documents entitled ‘‘Coronary Drug- • Mail/Hand Delivery/Courier (for and other applicable disclosure law. For
Eluting Stents—Nonclinical and written/paper submissions): Dockets more information about FDA’s posting
daltland on DSKBBV9HB2PROD with NOTICES
Clinical Studies’’ and ‘‘Coronary Drug- Management Staff (HFA–305), Food and of comments to public dockets, see 80
Eluting Stents—Nonclinical and Drug Administration, 5630 Fishers FR 56469, September 18, 2015, or access
Clinical Studies Draft Companion Lane, Rm. 1061, Rockville, MD 20852. the information at: https://www.gpo.gov/
Guidance Document.’’ The Agency is • For written/paper comments fdsys/pkg/FR-2015-09-18/pdf/2015-
reopening the comment period to allow submitted to the Dockets Management 23389.pdf.
interested persons to provide updated Staff, FDA will post your comment, as Docket: For access to the docket to
comments and any new information. well as any attachments, except for read background documents or the
VerDate Sep<11>2014 17:20 Sep 26, 2018 Jkt 244001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\27SEN1.SGM 27SEN1](https://thefederalregister.org/doc/83_FR_49012/page/1.svg)
![Federal Register / Vol. 83, No. 188 / Thursday, September 27, 2018 / Notices 48825
electronic and written/paper comments the public. You can use an alternative DEPARTMENT OF HEALTH AND
received, go to https:// approach if it satisfies the requirements HUMAN SERVICES
www.regulations.gov and insert the of the applicable statutes and
docket number, found in brackets in the regulations. The guidances are not Food and Drug Administration
heading of this document, into the subject to Executive Order 12866. [Docket No. FDA–2018–D–1752]
‘‘Search’’ box and follow the prompts
FDA is reopening the comment period
and/or go to the Dockets Management Public Availability of Lists of Retail
to consider any new information and
Staff, 5630 Fishers Lane, Rm. 1061, Consignees To Effectuate Certain
Rockville, MD 20852. intends to issue revised versions of
Human and Animal Food Recalls; Draft
You may submit comments on any these draft guidances for further
Guidance for Industry and Food and
guidance at any time (see 21 CFR consideration. This action will help the Drug Administration Staff; Availability
10.115(g)(5)). Center for Devices and Radiological
An electronic copy of the guidance Health fulfill its commitment to finalize, AGENCY: Food and Drug Administration,
documents is available for download withdraw, or reopen the comment HHS.
from the internet. See the period for 50 percent of existing draft ACTION: Notice of availability.
SUPPLEMENTARY INFORMATION section for guidances issued prior to October 1,
SUMMARY: The Food and Drug
information on electronic access to the 2012 (82 FR 58429, December 12, 2017). Administration (FDA, we, or Agency) is
guidances. Submit written requests for a FDA is reopening the comment period announcing the availability of a draft
single hard copy of the draft guidance for 90 days. The Agency believes that a guidance for industry and FDA staff
documents entitled ‘‘Coronary Drug- 90-day extension allows adequate time entitled ‘‘Public Availability of Lists of
Eluting Stents—Nonclinical and for interested parties to submit Retail Consignees to Effectuate Certain
Clinical Studies’’ and ‘‘Coronary Drug- comments. Previously submitted Human and Animal Food Recalls.’’ The
Eluting Stents—Nonclinical and comments do not need to be draft guidance, when finalized,
Clinical Studies Draft Companion establishes guidance for industry and
resubmitted for consideration.
Guidance Document’’ to the Office of FDA staff on how and when FDA
the Center Director, Guidance and II. Electronic Access intends to collect, compile, and
Policy Development, Center for Devices publicize retail consignees that may
and Radiological Health, Food and Drug Persons interested in obtaining a copy
have received recalled foods. While
Administration, 10903 New Hampshire of the draft guidances may do so by
FDA intends to focus on recalls where
Ave., Bldg. 66, Rm. 5431, Silver Spring, downloading an electronic copy from there is a reasonable probability that the
MD 20993–0002. Send one self- the internet. A search capability for all use of, or exposure to, the food will
addressed adhesive label to assist that Center for Devices and Radiological cause serious adverse health
office in processing your request. Health guidance documents is available consequences or death to humans or
FOR FURTHER INFORMATION CONTACT: at https://www.fda.gov/MedicalDevices/ animals (Class I recalls), FDA may also
Michael John, Center for Devices and DeviceRegulationandGuidance/ publicize retail consignee lists for other
Radiological Health, Food and Drug GuidanceDocuments/default.htm. The food recalls as described in the draft
Administration, 10903 New Hampshire draft guidance documents are also guidance. FDA’s goal is to publicize
Ave., Bldg. 66, Rm. 1224, Silver Spring, available at https:// retail consignee lists for these food
MD 20993–0002, 301–796–6329, www.regulations.gov. Persons unable to recalls where providing this additional
Michael.John@fda.hhs.gov or Kimberly download an electronic copy of information will be of the most use to
Peters, Center for Drug Evaluation and ‘‘Coronary Drug-Eluting Stents— consumers to help them identify
Research, Food and Drug Nonclinical and Clinical Studies’’ and recalled food and to determine whether
Administration, 10903 New Hampshire ‘‘Coronary Drug-Eluting Stents— that food is in their possession as
Ave., Bldg. 51, Rm. 4314, Silver Spring, Nonclinical and Clinical Studies Draft effectively and quickly as possible.
MD 20993–0002, 301–796–6350, Companion Guidance Document’’ may DATES: Submit either electronic or
Kimberly.Peters@fda.hhs.gov. send an email request to CDRH- written comments on the draft guidance
SUPPLEMENTARY INFORMATION: Guidance@fda.hhs.gov to receive an by November 26, 2018 to ensure that the
electronic copy of the document. Please Agency considers your comment on this
I. Background
use the document number 6255 to draft guidance before it begins work on
In the Federal Register of March 27, identify the guidance you are the final version of the guidance.
2008, FDA published a notice of ADDRESSES: You may submit comments
requesting.
availability with a 120-day comment as follows:
period to request comments on the draft Dated: September 21, 2018.
guidances entitled ‘‘Coronary Drug- Leslie Kux, Electronic Submissions
Eluting Stents—Nonclinical and Associate Commissioner for Policy. Submit electronic comments in the
Clinical Studies’’ and ‘‘Coronary Drug- [FR Doc. 2018–21041 Filed 9–26–18; 8:45 am] following way:
Eluting Stents—Nonclinical and • Federal eRulemaking Portal:
BILLING CODE 4164–01–P
Clinical Studies Draft Companion https://www.regulations.gov. Follow the
Guidance Document.’’ instructions for submitting comments.
The draft guidances are being issued Comments submitted electronically,
consistent with FDA’s good guidance including attachments, to https://
daltland on DSKBBV9HB2PROD with NOTICES
practices regulation (21 CFR 10.115). www.regulations.gov will be posted to
The draft guidances, when finalized, the docket unchanged. Because your
will represent the current thinking of comment will be made public, you are
FDA on coronary drug-eluting stents— solely responsible for ensuring that your
nonclinical and clinical studies. They comment does not include any
do not establish any rights for any confidential information that you or a
person and are not binding on FDA or third party may not wish to be posted,
VerDate Sep<11>2014 17:20 Sep 26, 2018 Jkt 244001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\27SEN1.SGM 27SEN1](https://thefederalregister.org/doc/83_FR_49012/page/2.svg)
Document Created: 2018-09-27 01:03:56
Document Modified: 2018-09-27 01:03:56
| 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; reopening of the comment period. | |
| 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. | |
| 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] | |
| FR Citation | 83 FR 48824 |
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