83 FR 48447 - Pediatric Medical Device Development; Public Meeting; Request for Comments; Reopening of Comment Period
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 186 (September 25, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 186 (September 25, 2018)
| Page Range | 48447-48448 | |
| FR Document | 2018-20795 |
[Federal Register Volume 83, Number 186 (Tuesday, September 25, 2018)] [Notices] [Pages 48447-48448] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-20795] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-0404] Pediatric Medical Device Development; Public Meeting; Request for Comments; Reopening of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; reopening of comment period. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is reopening the comment period provided in the notice entitled ``Pediatric Medical Device Development; Public Meeting; Request for Comments'' that appeared in the Federal Register on February 16, 2018. That notice announced the public meeting to be held on August 13 and 14, 2018, and requested comments by September 14, 2018. FDA is reopening the public meeting's comment period until November 26, 2018. The Agency is taking this action to allow interested parties additional time to submit comments. DATES: FDA is reopening the comment period for the public meeting ``Pediatric Medical Device Development; Public Meeting; Request for Comments'' published on February 16, 2018 (83 FR 7052). Submit either electronic or written comments on this meeting by November 26, 2018. ADDRESSES: You may submit comments 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-2018-N-0404 for ``Pediatric Medical Device Development; Public Meeting; Request for Comments; Reopening of Comment Period.'' 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 [[Page 48448]] 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: Victoria Wagman, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5562, Silver Spring, MD 20993, 301-796- 6581, Victoria.Wagman@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of February 16, 2018 (83 FR 7052), FDA published a notice announcing the public meeting entitled ``Pediatric Medical Device Development'' with a 30-day comment period post the meeting to request comments. The public meeting was held on August 13 and 14, 2018. FDA is reopening the comment period for the public meeting until November 26, 2018. The Agency believes that this will allow adequate time for interested persons to submit comments without significantly delaying action by the Agency. Dated: September 19, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-20795 Filed 9-24-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 186 / Tuesday, September 25, 2018 / Notices 48447
HCV, as required under § 610.40(e) (21 21 CFR 630.40 have been approved including attachments, to https://
CFR 610.40(e)). The draft guidance also under OMB control number 0910–0116. www.regulations.gov will be posted to
provides guidance to blood the docket unchanged. Because your
III. Electronic Access
establishments on how to report the comment will be made public, you are
implementation of these Persons with access to the internet solely responsible for ensuring that your
recommendations. may obtain the draft guidance at either comment does not include any
In accordance with § 610.40(e), each https://www.fda.gov/Biologics confidential information that you or a
donation, including autologous BloodVaccines/GuidanceCompliance third party may not wish to be posted,
donations, found to be reactive by a RegulatoryInformation/Guidances/ such as medical information, your or
donor screening test must be further default.htm or https:// anyone else’s Social Security number, or
tested using a licensed, approved, or www.regulations.gov. confidential business information, such
cleared supplemental test, when Dated: September 18, 2018. as a manufacturing process. Please note
available. If no such supplemental test that if you include your name, contact
Leslie Kux,
is available, blood establishments must information, or other information that
Associate Commissioner for Policy.
perform one or more licensed, identifies you in the body of your
approved, or cleared tests as adequate [FR Doc. 2018–20776 Filed 9–24–18; 8:45 am]
comments, that information will be
and appropriate to provide additional BILLING CODE 4164–01–P posted on https://www.regulations.gov.
information concerning the reactive • If you want to submit a comment
donor’s infection status (§ 610.40(e)). with confidential information that you
The draft guidance provides DEPARTMENT OF HEALTH AND do not wish to be made available to the
recommendations for adequate and HUMAN SERVICES public, submit the comment as a
appropriate testing under § 610.40(e), written/paper submission and in the
Food and Drug Administration
with the licensed HCV NAT (nucleic manner detailed (see ‘‘Written/Paper
acid test) and anti-HCV donor screening [Docket No. FDA–2018–N–0404] Submissions’’ and ‘‘Instructions’’).
tests that are currently available, to
Pediatric Medical Device Development; Written/Paper Submissions
provide additional information
concerning the anti-HCV reactive Public Meeting; Request for Submit written/paper submissions as
donor’s infection status. The draft Comments; Reopening of Comment follows:
guidance, when finalized, will update Period • Mail/Hand delivery/Courier (for
the recommendations related to the use written/paper submissions): Dockets
AGENCY: Food and Drug Administration, Management Staff (HFA–305), Food and
of an appropriate multiantigen HHS.
supplemental test contained in Drug Administration, 5630 Fishers
ACTION: Notice; reopening of comment Lane, Rm. 1061, Rockville, MD 20852.
‘‘Guidance for Industry: ‘Lookback’ for
Hepatitis C Virus (HCV): Product period. • For written/paper comments
Quarantine, Consignee Notification, submitted to the Dockets Management
SUMMARY: The Food and Drug
Further Testing, Product Disposition, Staff, FDA will post your comment, as
Administration (FDA or Agency) is
and Notification of Transfusion well as any attachments, except for
reopening the comment period provided
Recipients Based on Donor Test Results information submitted, marked and
in the notice entitled ‘‘Pediatric Medical
Indicating Infection with HCV’’ dated identified, as confidential, if submitted
Device Development; Public Meeting;
December 2010. as detailed in ‘‘Instructions’’.
Request for Comments’’ that appeared in Instructions: All submissions received
This draft guidance is being issued the Federal Register on February 16,
consistent with FDA’s good guidance must include the Docket No. FDA–
2018. That notice announced the public 2018–N–0404 for ‘‘Pediatric Medical
practices regulation (21 CFR 10.115). meeting to be held on August 13 and 14,
The draft guidance, when finalized, will Device Development; Public Meeting;
2018, and requested comments by Request for Comments; Reopening of
represent the current thinking of FDA September 14, 2018. FDA is reopening
on further testing of donations that are Comment Period.’’ Received comments
the public meeting’s comment period will be placed in the docket and, except
reactive on a licensed donor screening until November 26, 2018. The Agency is
test for antibodies to HCV. It does not for those submitted as ‘‘Confidential
taking this action to allow interested Submissions,’’ publicly viewable at
establish any rights for any person and parties additional time to submit
is not binding on FDA or the public. https://www.regulations.gov or at the
comments. Dockets Management Staff between 9
You can use an alternative approach if
it satisfies the requirements of the DATES: FDA is reopening the comment a.m. and 4 p.m., Monday through
applicable statutes and regulations. This period for the public meeting ‘‘Pediatric Friday.
guidance is not subject to Executive Medical Device Development; Public • Confidential Submissions—To
Order 12866. Meeting; Request for Comments’’ submit a comment with confidential
published on February 16, 2018 (83 FR information that you do not wish to be
II. Paperwork Reduction Act of 1995 7052). Submit either electronic or made publicly available, submit your
This draft guidance refers to written comments on this meeting by comments only as a written/paper
previously approved collections of November 26, 2018. submission. You should submit two
information found in FDA regulations. ADDRESSES: You may submit comments copies total. One copy will include the
These collections of information are as follows: information you claim to be confidential
subject to review by the Office of with a heading or cover note that states
daltland on DSKBBV9HB2PROD with NOTICES
Management and Budget (OMB) under Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
the Paperwork Reduction Act of 1995 Submit electronic comments in the CONFIDENTIAL INFORMATION’’. The
(44 U.S.C. 3501–3520). The collections following way: Agency will review this copy, including
of information in 21 CFR part 601 have • Federal eRulemaking Portal: the claimed confidential information, in
been approved under OMB control https://www.regulations.gov. Follow the its consideration of comments. The
number 0910–0338; and the collections instructions for submitting comments. second copy, which will have the
of information in 21 CFR part 610 and Comments submitted electronically, claimed confidential information
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![48448 Federal Register / Vol. 83, No. 186 / Tuesday, September 25, 2018 / Notices
redacted/blacked out, will be available DEPARTMENT OF HEALTH AND do not wish to be made available to the
for public viewing and posted on HUMAN SERVICES public, submit the comment as a
https://www.regulations.gov. Submit written/paper submission and in the
both copies to the Dockets Management Food and Drug Administration manner detailed (see ‘‘Written/Paper
Staff. If you do not wish your name and [Docket No. FDA–2018–D–3324] Submissions’’ and ‘‘Instructions’’).
contact information to be made publicly Written/Paper Submissions
available, you can provide this Recommendations for Requalification
of Blood Donors Deferred Because of Submit written/paper submissions as
information on the cover sheet and not
Reactive Test Results for Antibodies to follows:
in the body of your comments and you • Mail/Hand Delivery/Courier (for
must identify this information as Human T-Lymphotropic Virus Types I
and II; Draft Guidance for Industry; written/paper submissions): Dockets
‘‘confidential’’. Any information marked Management Staff (HFA–305), Food and
as ‘‘confidential’’ will not be disclosed Availability
Drug Administration, 5630 Fishers
except in accordance with 21 CFR 10.20 AGENCY: Food and Drug Administration, Lane, Rm. 1061, Rockville, MD 20852.
and other applicable disclosure law. For HHS. • For written/paper comments
more information about FDA’s posting ACTION: Notice of availability. submitted to the Dockets Management
of comments to public dockets, see 80 Staff, FDA will post your comment as
FR 56469, September 18, 2015, or access SUMMARY: The Food and Drug well as any attachments, except for
the information at: https://www.gpo.gov/ Administration (FDA or Agency) is information submitted, marked, and
fdsys/pkg/FR-2015-09-18/pdf/2015- announcing the availability of a draft identified as confidential, if submitted
23389.pdf. document entitled ‘‘Recommendations as detailed in ‘‘Instructions.’’
for Requalification of Blood Donors Instructions: All submissions received
Docket: For access to the docket to Deferred Because of Reactive Test must include the Docket No. FDA–
read background documents or the Results for Antibodies to Human T- 2018–D–3324 for ‘‘Recommendations
electronic and written/paper comments Lymphotropic Virus Types I and II (anti- for Requalification of Blood Donors
received, go to https:// HTLV–I/II); Draft Guidance for Deferred Because of Reactive Test
www.regulations.gov and insert the Industry.’’ The draft guidance document Results for Antibodies to Human T-
docket number, found in brackets in the provides blood establishments that Lymphotropic Virus Types I and II (anti-
heading of this document, into the collect Whole Blood and blood HTLV–I/II); Draft Guidance for
‘‘Search’’ box and follow the prompts components with recommendations for Industry.’’ Received comments will be
and/or go to the Dockets Management a requalification method for deferred placed in the docket and, except for
Staff, 5630 Fishers Lane, Rm. 1061, donors, based on a determination that those submitted as ‘‘Confidential
Rockville, MD 20852. their previous reactive test results for Submissions,’’ will be publicly viewable
anti-HTLV–I/II were falsely positive. at https://www.regulations.gov or at the
FOR FURTHER INFORMATION CONTACT: Dockets Management Staff between 9
DATES: Submit either electronic or
Victoria Wagman, Center for Devices written comments on the draft guidance a.m. and 4 p.m., Monday through
and Radiological Health, Food and Drug by December 24, 2018 to ensure that the Friday.
Administration, 10903 New Hampshire Agency considers your comment on this • Confidential Submissions—To
Ave., Bldg. 66, Rm. 5562, Silver Spring, draft guidance before it begins work on submit a comment with confidential
MD 20993, 301–796–6581, the final version of the guidance. information that you do not wish to be
Victoria.Wagman@fda.hhs.gov. ADDRESSES: You may submit comments made publicly available, submit your
on any guidance at any time as follows: comments only as a written/paper
SUPPLEMENTARY INFORMATION:
submission. You should submit two
I. Background Electronic Submissions copies total. One copy will include the
Submit electronic comments in the information you claim to be confidential
In the Federal Register of February following way: with a heading or cover note that states
16, 2018 (83 FR 7052), FDA published • Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS
a notice announcing the public meeting https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
entitled ‘‘Pediatric Medical Device instructions for submitting comments. Agency will review this copy, including
Development’’ with a 30-day comment Comments submitted electronically, the claimed confidential information, in
period post the meeting to request including attachments, to https:// its consideration of comments. The
comments. The public meeting was held www.regulations.gov will be posted to second copy, which will have the
on August 13 and 14, 2018. FDA is the docket unchanged. Because your claimed confidential information
reopening the comment period for the comment will be made public, you are redacted/blacked out, will be available
public meeting until November 26, solely responsible for ensuring that your for public viewing and posted on
2018. The Agency believes that this will comment does not include any https://www.regulations.gov. Submit
allow adequate time for interested confidential information that you or a both copies to the Dockets Management
persons to submit comments without third party may not wish to be posted, Staff. If you do not wish your name and
significantly delaying action by the such as medical information, your or contact information to be made publicly
Agency. anyone else’s Social Security number, or available, you can provide this
confidential business information, such information on the cover sheet and not
Dated: September 19, 2018. as a manufacturing process. Please note in the body of your comments, and you
daltland on DSKBBV9HB2PROD with NOTICES
Leslie Kux, that if you include your name, contact must identify this information as
Associate Commissioner for Policy. information, or other information that ‘‘confidential.’’ Any information marked
[FR Doc. 2018–20795 Filed 9–24–18; 8:45 am] identifies you in the body of your as ‘‘confidential’’ will not be disclosed
BILLING CODE 4164–01–P
comments, that information will be except in accordance with 21 CFR 10.20
posted on https://www.regulations.gov. and other applicable disclosure law. For
• If you want to submit a comment more information about FDA’s posting
with confidential information that you of comments to public dockets, see 80
VerDate Sep<11>2014 17:40 Sep 24, 2018 Jkt 244001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\25SEN1.SGM 25SEN1](https://thefederalregister.org/doc/83_FR_48633/page/2.svg)
Document Created: 2018-09-25 00:22:32
Document Modified: 2018-09-25 00:22:32
| 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 comment period. | |
| Dates | FDA is reopening the comment period for the public meeting ``Pediatric Medical Device Development; Public Meeting; Request for Comments'' published on February 16, 2018 (83 FR 7052). Submit either electronic or written comments on this meeting by November 26, 2018. | |
| Contact | Victoria Wagman, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5562, Silver Spring, MD 20993, 301-796- 6581, [email protected] | |
| FR Citation | 83 FR 48447 |
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