83 FR 1619 - Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases; Draft Guidance for Industry; Availability; Extension of Comment Period
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 9 (January 12, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 9 (January 12, 2018)
| Page Range | 1619-1620 | |
| FR Document | 2018-00418 |
[Federal Register Volume 83, Number 9 (Friday, January 12, 2018)] [Notices] [Pages 1619-1620] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-00418] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-6380] Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases; Draft Guidance for Industry; Availability; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability; extension of comment period. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is extending the comment period for the notice of availability that appeared in the Federal Register of December 20, 2017. In the notice of availability, FDA requested comments on the draft guidance for industry entitled ``Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases.'' The Agency is taking this action in response to public interest in the draft guidance and to allow interested persons additional time to submit comments. DATES: FDA is extending the comment period on the notice of availability published December 20, 2017 (82 FR 60402). Submit either electronic or written comments on the draft guidance by February 18, 2018, to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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 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-2017-D-6380 for ``Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases.'' 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 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: Aaron Friedman, Office of Orphan Products Development, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5295, Silver Spring, MD 20993, 301-796-8660. SUPPLEMENTARY INFORMATION: In the Federal Register of December 20, 2017, FDA published a notice of availability with a 30-day comment period to request comments on the draft guidance for industry entitled ``Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases.'' 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 current thinking of FDA on orphan designation of drugs and biologics for pediatric subpopulations of common diseases. It does not establish any rights for any person and is not binding on FDA or the public. You can [[Page 1620]] use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This draft guidance is not subject to Executive Order 12866. Based on public interest in the draft guidance, FDA is extending the comment period for the notice of availability for 30 days, until February 28, 2018. The Agency believes that a 30-day extension allows adequate time for interested persons to submit comments without significantly delaying guidance on these important issues. Dated: January 8, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-00418 Filed 1-11-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 9 / Friday, January 12, 2018 / Notices 1619
FDA has considered the request and draft guidance before it begins work on comments only as a written/paper
is reopening the comment period for the the final version of the guidance. submission. You should submit two
draft guidance for 30 days, until ADDRESSES: You may submit comments copies total. One copy will include the
February 12, 2018. The Agency believes on any guidance at any time as follows: information you claim to be confidential
that a 30-day reopening of the comment with a heading or cover note that states
period allows adequate time for Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
interested persons to submit comments Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
to ensure that the Agency can consider following way: Agency will review this copy, including
the comments on this draft guidance • Federal eRulemaking Portal: the claimed confidential information, in
before it begins work on the final https://www.regulations.gov. Follow the its consideration of comments. The
version of the guidance. instructions for submitting comments. second copy, which will have the
Comments submitted electronically, claimed confidential information
II. Electronic Access including attachments, to https:// redacted/blacked out, will be available
Persons with access to the internet www.regulations.gov will be posted to for public viewing and posted on
may obtain the draft guidance at either the docket unchanged. Because your https://www.regulations.gov. Submit
https://www.fda.gov/Drugs/Guidance comment will be made public, you are both copies to the Dockets Management
ComplianceRegulatoryInformation/ solely responsible for ensuring that your Staff. If you do not wish your name and
Guidances/default.htm or https:// comment does not include any contact information to be made publicly
www.regulations.gov. confidential information that you or a available, you can provide this
Dated: January 8, 2018.
third party may not wish to be posted, information on the cover sheet and not
such as medical information, your or in the body of your comments and you
Leslie Kux,
anyone else’s Social Security number, or must identify this information as
Associate Commissioner for Policy. confidential business information, such ‘‘confidential.’’ Any information marked
[FR Doc. 2018–00405 Filed 1–11–18; 8:45 am] as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed
BILLING CODE 4164–01–P that if you include your name, contact except in accordance with 21 CFR 10.20
information, or other information that and other applicable disclosure law. For
identifies you in the body of your more information about FDA’s posting
DEPARTMENT OF HEALTH AND comments, that information will be
HUMAN SERVICES of comments to public dockets, see 80
posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access
• If you want to submit a comment the information at: https://www.gpo.gov/
Food and Drug Administration
with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015-
do not wish to be made available to the 23389.pdf.
[Docket No. FDA–2017–D–6380] public, submit the comment as a Docket: For access to the docket to
written/paper submission and in the read background documents or the
Clarification of Orphan Designation of manner detailed (see ‘‘Written/Paper
Drugs and Biologics for Pediatric electronic and written/paper comments
Submissions’’ and ‘‘Instructions’’). received, go to https://
Subpopulations of Common Diseases;
Draft Guidance for Industry; Written/Paper Submissions www.regulations.gov and insert the
Availability; Extension of Comment docket number, found in brackets in the
Submit written/paper submissions as heading of this document, into the
Period follows: ‘‘Search’’ box and follow the prompts
AGENCY: Food and Drug Administration, • Mail/Hand delivery/Courier (for
and/or go to the Dockets Management
HHS. written/paper submissions): Dockets
Staff, 5630 Fishers Lane, Rm. 1061,
Management Staff (HFA–305), Food and
ACTION:Notice of availability; extension Rockville, MD 20852.
Drug Administration, 5630 Fishers
of comment period. Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT:
• For written/paper comments Aaron Friedman, Office of Orphan
SUMMARY: The Food and Drug Products Development, Food and Drug
Administration (FDA or Agency) is submitted to the Dockets Management
Staff, FDA will post your comment, as Administration, 10903 New Hampshire
extending the comment period for the Ave., Bldg. 32, Rm. 5295, Silver Spring,
notice of availability that appeared in well as any attachments, except for
information submitted, marked and MD 20993, 301–796–8660.
the Federal Register of December 20,
identified, as confidential, if submitted SUPPLEMENTARY INFORMATION: In the
2017. In the notice of availability, FDA
as detailed in ‘‘Instructions.’’ Federal Register of December 20, 2017,
requested comments on the draft
Instructions: All submissions received FDA published a notice of availability
guidance for industry entitled
must include the Docket No. FDA– with a 30-day comment period to
‘‘Clarification of Orphan Designation of
2017–D–6380 for ‘‘Clarification of request comments on the draft guidance
Drugs and Biologics for Pediatric
Orphan Designation of Drugs and for industry entitled ‘‘Clarification of
Subpopulations of Common Diseases.’’
Biologics for Pediatric Subpopulations Orphan Designation of Drugs and
The Agency is taking this action in
of Common Diseases.’’ Received Biologics for Pediatric Subpopulations
response to public interest in the draft
comments will be placed in the docket of Common Diseases.’’
guidance and to allow interested This draft guidance is being issued
and, except for those submitted as
persons additional time to submit consistent with FDA’s good guidance
‘‘Confidential Submissions,’’ publicly
comments. practices regulation (21 CFR 10.115).
sradovich on DSK3GMQ082PROD with NOTICES
viewable at https://www.regulations.gov
DATES: FDA is extending the comment or at the Dockets Management Staff The draft guidance, when finalized, will
period on the notice of availability between 9 a.m. and 4 p.m., Monday represent the current thinking of FDA
published December 20, 2017 (82 FR through Friday. on orphan designation of drugs and
60402). Submit either electronic or • Confidential Submissions—To biologics for pediatric subpopulations of
written comments on the draft guidance submit a comment with confidential common diseases. It does not establish
by February 18, 2018, to ensure that the information that you do not wish to be any rights for any person and is not
Agency considers your comment on this made publicly available, submit your binding on FDA or the public. You can
VerDate Sep<11>2014 17:47 Jan 11, 2018 Jkt 244001 PO 00000 Frm 00015 Fmt 4703 Sfmt 4703 E:\FR\FM\12JAN1.SGM 12JAN1](https://thefederalregister.org/doc/83_FR_1628/page/1.svg)
![1620 Federal Register / Vol. 83, No. 9 / Friday, January 12, 2018 / Notices
use an alternative approach if it satisfies considered. Electronic comments must placed in the docket and, except for
the requirements of the applicable be submitted on or before March 13, those submitted as ‘‘Confidential
statutes and regulations. This draft 2018. The https://www.regulations.gov Submissions,’’ publicly viewable at
guidance is not subject to Executive electronic filing system will accept https://www.regulations.gov or at the
Order 12866. comments until midnight Eastern Time Dockets Management Staff between 9
Based on public interest in the draft at the end of March 13, 2018. Comments a.m. and 4 p.m., Monday through
guidance, FDA is extending the received by mail/hand delivery/courier Friday.
comment period for the notice of (for written/paper submissions) will be • Confidential Submissions—To
availability for 30 days, until February considered timely if they are submit a comment with confidential
28, 2018. The Agency believes that a 30- postmarked or the delivery service information that you do not wish to be
day extension allows adequate time for acceptance receipt is on or before that made publicly available, submit your
interested persons to submit comments date. comments only as a written/paper
without significantly delaying guidance submission. You should submit two
Electronic Submissions
on these important issues. copies total. One copy will include the
Dated: January 8, 2018.
Submit electronic comments in the information you claim to be confidential
following way: with a heading or cover note that states
Leslie Kux, • Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS
Associate Commissioner for Policy. https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
[FR Doc. 2018–00418 Filed 1–11–18; 8:45 am] instructions for submitting comments. Agency will review this copy, including
BILLING CODE 4164–01–P Comments submitted electronically, the claimed confidential information, in
including attachments, to https:// its consideration of comments. The
www.regulations.gov will be posted to second copy, which will have the
DEPARTMENT OF HEALTH AND the docket unchanged. Because your claimed confidential information
HUMAN SERVICES comment will be made public, you are redacted/blacked out, will be available
solely responsible for ensuring that your for public viewing and posted on
Food and Drug Administration
comment does not include any https://www.regulations.gov. Submit
[Docket Nos. FDA–2016–E–2516 and FDA– confidential information that you or a both copies to the Dockets Management
2016–E–2514] third party may not wish to be posted, Staff. If you do not wish your name and
such as medical information, your or contact information to be made publicly
Determination of Regulatory Review anyone else’s Social Security number, or
Period for Purposes of Patent available, you can provide this
confidential business information, such information on the cover sheet and not
Extension; PROACT ADJUSTABLE as a manufacturing process. Please note
CONTINENCE THERAPY FOR MEN in the body of your comments and you
that if you include your name, contact must identify this information as
AGENCY: Food and Drug Administration, information, or other information that ‘‘confidential.’’ Any information marked
HHS. identifies you in the body of your as ‘‘confidential’’ will not be disclosed
ACTION: Notice. comments, that information will be except in accordance with § 10.20 (21
posted on https://www.regulations.gov. CFR 10.20) and other applicable
SUMMARY: The Food and Drug • If you want to submit a comment disclosure law. For more information
Administration (FDA or the Agency) has with confidential information that you about FDA’s posting of comments to
determined the regulatory review period do not wish to be made available to the public dockets, see 80 FR 56469,
for PROACT ADJUSTABLE public, submit the comment as a September 18, 2015, or access the
CONTINENCE THERAPY FOR MEN written/paper submission and in the information at: https://www.gpo.gov/
and is publishing this notice of that manner detailed (see ‘‘Written/Paper fdsys/pkg/FR-2015-09-18/pdf/2015-
determination as required by law. FDA Submissions’’ and ‘‘Instructions’’). 23389.pdf.
has made the determination because of Written/Paper Submissions Docket: For access to the docket to
the submission of applications to the read background documents or the
Director of the U.S. Patent and Submit written/paper submissions as
electronic and written/paper comments
Trademark Office (USPTO), Department follows:
• Mail/Hand delivery/Courier (for received, go to https://
of Commerce, for the extension of a www.regulations.gov and insert the
patent which claims that medical written/paper submissions): Dockets
Management Staff (HFA–305), Food and docket number, found in brackets in the
device. heading of this document, into the
Drug Administration, 5630 Fishers
DATES: Anyone with knowledge that any Lane, Rm. 1061, Rockville, MD 20852. ‘‘Search’’ box and follow the prompts
of the dates as published (in the • For written/paper comments and/or go to the Dockets Management
SUPPLEMENTARY INFORMATION section) are submitted to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061,
incorrect may submit either electronic Staff, FDA will post your comment, as Rockville, MD 20852.
or written comments and ask for a well as any attachments, except for FOR FURTHER INFORMATION CONTACT:
redetermination by March 13, 2018. information submitted, marked and Beverly Friedman, Office of Regulatory
Furthermore, any interested person may identified, as confidential, if submitted Policy, Food and Drug Administration,
petition FDA for a determination as detailed in ‘‘Instructions.’’ 10903 New Hampshire Ave., Bldg. 51,
regarding whether the applicant for Instructions: All submissions received Rm. 6250, Silver Spring, MD 20993,
extension acted with due diligence must include the Docket Nos. FDA– 301–796–3600.
sradovich on DSK3GMQ082PROD with NOTICES
during the regulatory review period by 2016–E–2516 and FDA–2016–E–2514 SUPPLEMENTARY INFORMATION:
July 11, 2018. See ‘‘Petitions’’ in the for ‘‘Determination of Regulatory
SUPPLEMENTARY INFORMATION section for Review Period for Purposes of Patent I. Background
more information. Extension; PROACT ADJUSTABLE The Drug Price Competition and
ADDRESSES: You may submit comments CONTINENCE THERAPY FOR MEN.’’ Patent Term Restoration Act of 1984
as follows. Please note that late, Received comments, those filed in a (Pub. L. 98–417) and the Generic
untimely filed comments will not be timely manner (see ADDRESSES), will be Animal Drug and Patent Term
VerDate Sep<11>2014 17:47 Jan 11, 2018 Jkt 244001 PO 00000 Frm 00016 Fmt 4703 Sfmt 4703 E:\FR\FM\12JAN1.SGM 12JAN1](https://thefederalregister.org/doc/83_FR_1628/page/2.svg)
Document Created: 2018-10-26 09:53:47
Document Modified: 2018-10-26 09:53:47
| 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 of availability; extension of comment period. | |
| Dates | FDA is extending the comment period on the notice of availability published December 20, 2017 (82 FR 60402). Submit either electronic or written comments on the draft guidance by February 18, 2018, to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Aaron Friedman, Office of Orphan Products Development, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5295, Silver Spring, MD 20993, 301-796-8660. | |
| FR Citation | 83 FR 1619 |
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