83 FR 2952 - Devices Proposed for a New Use With an Approved, Marketed Drug; Public Hearing; Reopening of the Comment Period
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 14 (January 22, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 14 (January 22, 2018)
| Page Range | 2952-2953 | |
| FR Document | 2018-00991 |
[Federal Register Volume 83, Number 14 (Monday, January 22, 2018)] [Proposed Rules] [Pages 2952-2953] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-00991] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 15 [Docket No. FDA-2017-N-5319] Devices Proposed for a New Use With an Approved, Marketed Drug; Public Hearing; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notification of public hearing; reopening of the comment period. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is reopening the comment period for the document published in the Federal Register on September 26, 2017, announcing a public hearing on a potential approach for device sponsors who seek to obtain marketing authorization for their products that are intended for a new use with an approved, marketed drug when the sponsor for the approved, marketed drug does not wish to pursue or collaborate on the new use. In the document, in addition to seeking comments on the potential approach, FDA also welcomed comments on public health, scientific, regulatory, or legal considerations relating to other medical products intended for new uses with approved, marketed medical products of a different type where the sponsor for the approved, marketed product does not wish to pursue or collaborate on the new use. We are reopening the comment period in response to a request for an extension to allow interested persons additional time to submit comments. DATES: FDA is reopening the comment period on the document published on September 26, 2017 (82 FR 44803). Submit either electronic or written comments by February 21, 2018. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before February 21, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of February 21, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. 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-N-5319 for ``Devices Proposed for a New Use With an Approved, Marketed Drug; Public Hearing; Request for Comments.'' Received comments, those filed in a timely manner (see ADDRESSES), 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: John Barlow Weiner, Office of Combination Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, [[Page 2953]] MD 20993, 301-796-8930, [email protected]. SUPPLEMENTARY INFORMATION: In the Federal Register on September 26, 2017 (82 FR 44803), FDA published a document announcing a public hearing on November 16, 2017, regarding a potential approach for device sponsors who seek to obtain marketing authorization for their products that are intended for a new use with an approved, marketed drug when the sponsor for the approved, marketed drug does not wish to pursue or collaborate on the new use. The purpose of the public hearing was to obtain comments from stakeholders on the potential approach presented in the Federal Register document as well as comments on public health, scientific, regulatory, or legal considerations relating to other medical products intended for new uses with approved, marketed medical products of a different type where the sponsor for the approved, marketed product does not wish to pursue or collaborate on the new use. We sought this type of public engagement because of the potential importance of the issue for public health and the need for input across the medical product industry and among public health stakeholders regarding how FDA should proceed. The comments that FDA receives in relation to this public hearing may help inform the further development of this approach. The document stated that comments would be accepted until January 15, 2018, and that untimely comments would not be considered. Near the end of the comment period, we received a request, submitted on behalf of several potential commenters, for more time to develop comments. We have considered this request and are reopening the comment period for an additional 30 days. We believe that this reopening allows adequate time for interested persons to submit comments without delaying further Agency efforts on this topic. Dated: January 16, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-00991 Filed 1-19-18; 8:45 am] BILLING CODE 4164-01-P
![2952 Federal Register / Vol. 83, No. 14 / Monday, January 22, 2018 / Proposed Rules
appropriate to the product. Any allow interested persons additional time identified, as confidential, if submitted
advertised R-value claims must fairly to submit comments. as detailed in ‘‘Instructions.’’
reflect the results of those tests. For the DATES: FDA is reopening the comment Instructions: All submissions received
purposes of this section, fenestration- period on the document published on must include the Docket No. FDA–
related products include windows, September 26, 2017 (82 FR 44803). 2017–N–5319 for ‘‘Devices Proposed for
doors, and skylights as well as Submit either electronic or written a New Use With an Approved, Marketed
attachments for those products. comments by February 21, 2018. Drug; Public Hearing; Request for
■ 14. In Appendix to Part 460—
ADDRESSES: You may submit comments
Comments.’’ Received comments, those
Exemptions, add paragraph (d) to read as follows. Please note that late, filed in a timely manner (see
as follows: untimely filed comments will not be ADDRESSES), will be placed in the docket
considered. Electronic comments must and, except for those submitted as
In Appendix to Part 460—Exemptions
be submitted on or before February 21, ‘‘Confidential Submissions,’’ publicly
* * * * * viewable at https://www.regulations.gov
(d) The requirements in §§ 460.6 through
2018. The https://www.regulations.gov
electronic filing system will accept or at the Dockets Management Staff
460.21 of this part do not apply to R-value between 9 a.m. and 4 p.m., Monday
claims covered by § 460.22. comments until midnight Eastern Time
at the end of February 21, 2018. through Friday.
By direction of the Commission.
Comments received by mail/hand • Confidential Submissions—To
Donald S. Clark, submit a comment with confidential
delivery/courier (for written/paper
Secretary. information that you do not wish to be
submissions) will be considered timely
[FR Doc. 2017–26569 Filed 1–19–18; 8:45 am] if they are postmarked or the delivery made publicly available, submit your
BILLING CODE 6750–01–P service acceptance receipt is on or comments only as a written/paper
before that date. submission. You should submit two
copies total. One copy will include the
Electronic Submissions information you claim to be confidential
DEPARTMENT OF HEALTH AND
Submit electronic comments in the with a heading or cover note that states
HUMAN SERVICES
following way: ‘‘THIS DOCUMENT CONTAINS
Food and Drug Administration • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
https://www.regulations.gov. Follow the Agency will review this copy, including
21 CFR Part 15 instructions for submitting comments. the claimed confidential information, in
Comments submitted electronically, its consideration of comments. The
[Docket No. FDA–2017–N–5319] second copy, which will have the
including attachments, to https://
www.regulations.gov will be posted to claimed confidential information
Devices Proposed for a New Use With redacted/blacked out, will be available
an Approved, Marketed Drug; Public the docket unchanged. Because your
comment will be made public, you are for public viewing and posted on
Hearing; Reopening of the Comment https://www.regulations.gov. Submit
Period solely responsible for ensuring that your
comment does not include any both copies to the Dockets Management
AGENCY: Food and Drug Administration, confidential information that you or a Staff. If you do not wish your name and
HHS. third party may not wish to be posted, contact information to be made publicly
such as medical information, your or available, you can provide this
ACTION:Notification of public hearing;
anyone else’s Social Security number, or information on the cover sheet and not
reopening of the comment period.
confidential business information, such in the body of your comments and you
SUMMARY: The Food and Drug as a manufacturing process. Please note must identify this information as
Administration (FDA, the Agency, or that if you include your name, contact ‘‘confidential.’’ Any information marked
we) is reopening the comment period information, or other information that as ‘‘confidential’’ will not be disclosed
for the document published in the identifies you in the body of your except in accordance with 21 CFR 10.20
Federal Register on September 26, 2017, comments, that information will be and other applicable disclosure law. For
announcing a public hearing on a posted on https://www.regulations.gov. more information about FDA’s posting
potential approach for device sponsors • If you want to submit a comment of comments to public dockets, see 80
who seek to obtain marketing with confidential information that you FR 56469, September 18, 2015, or access
authorization for their products that are do not wish to be made available to the the information at: https://www.gpo.gov/
intended for a new use with an public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
approved, marketed drug when the written/paper submission and in the 23389.pdf.
sponsor for the approved, marketed manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
drug does not wish to pursue or Submissions’’ and ‘‘Instructions’’). read background documents or the
collaborate on the new use. In the electronic and written/paper comments
document, in addition to seeking Written/Paper Submissions received, go to https://
comments on the potential approach, Submit written/paper submissions as www.regulations.gov and insert the
FDA also welcomed comments on follows: docket number, found in brackets in the
public health, scientific, regulatory, or • Mail/Hand delivery/Courier (for heading of this document, into the
legal considerations relating to other written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts
ethrower on DSK3G9T082PROD with PROPOSALS
medical products intended for new uses Management Staff (HFA–305), Food and and/or go to the Dockets Management
with approved, marketed medical Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061,
products of a different type where the Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852.
sponsor for the approved, marketed • For written/paper comments FOR FURTHER INFORMATION CONTACT: John
product does not wish to pursue or submitted to the Dockets Management Barlow Weiner, Office of Combination
collaborate on the new use. We are Staff, FDA will post your comment, as Products, Food and Drug
reopening the comment period in well as any attachments, except for Administration, 10903 New Hampshire
response to a request for an extension to information submitted, marked and Ave., Bldg. 32, Rm. 5129, Silver Spring,
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![Federal Register / Vol. 83, No. 14 / Monday, January 22, 2018 / Proposed Rules 2953
MD 20993, 301–796–8930, DEPARTMENT OF THE INTERIOR www.regulations.gov. Follow the
combination@fda.gov. instructions for submitting comments.
Office of Surface Mining Reclamation Instructions: All submissions received
SUPPLEMENTARY INFORMATION: In the and Enforcement must include the agency name and
Federal Register on September 26, 2017 docket number for this rulemaking. For
(82 FR 44803), FDA published a 30 CFR Part 901 detailed instructions on submitting
document announcing a public hearing comments and additional information
on November 16, 2017, regarding a [SATS No. AL–082–FOR; Docket ID: OSM–
2017–0011; S1D1S SS08011000 SX064A000 on the rulemaking process, see the
potential approach for device sponsors 189S180110; S2D2S SS08011000 ‘‘Public Comment Procedures’’ heading
who seek to obtain marketing SX064A000 18XS501520] of the SUPPLEMENTARY INFORMATION
authorization for their products that are section of this document.
intended for a new use with an Alabama Regulatory Program Docket: For access to the docket to
approved, marketed drug when the review copies of the Alabama program,
AGENCY: Office of Surface Mining this amendment, a listing of any
sponsor for the approved, marketed Reclamation and Enforcement, Interior.
drug does not wish to pursue or scheduled public hearings, and all
ACTION: Proposed rule; public comment written comments received in response
collaborate on the new use. The purpose
period and opportunity for public to this document, you must go to the
of the public hearing was to obtain hearing on proposed amendment.
comments from stakeholders on the address listed below during normal
potential approach presented in the SUMMARY: We, the Office of Surface business hours, Monday through Friday,
Federal Register document as well as Mining Reclamation and Enforcement excluding holidays. You may receive
comments on public health, scientific, (OSMRE), are announcing receipt of a one free copy of the amendment by
proposed amendment to the Alabama contacting OSMRE’s Birmingham Field
regulatory, or legal considerations
regulatory program (Alabama program) Office or the full text of the program
relating to other medical products
under the Surface Mining Control and amendment is available for you to
intended for new uses with approved, review at www.regulations.gov.
marketed medical products of a Reclamation Act of 1977 (SMCRA or the
Act). Alabama proposes revisions to its William Joseph, Acting Director,
different type where the sponsor for the Birmingham Field Office, Office of
approved, marketed product does not program regarding annual permit fees.
Alabama revised its program at its own Surface Mining Reclamation and
wish to pursue or collaborate on the Enforcement, 135 Gemini Circle, Suite
new use. We sought this type of public initiative to raise revenues sufficient to
fund the Alabama Surface Mining 215, Homewood, Alabama 35209,
engagement because of the potential Telephone: (205) 290–7282, email:
Commission’s (ASMC) share of costs to
importance of the issue for public health bjoseph@osmre.gov.
administer their coal regulatory
and the need for input across the In addition, you may review a copy of
program, including the cost of
medical product industry and among the amendment during regular business
reviewing, administering, inspecting,
public health stakeholders regarding hours at the following location:
and enforcing surface coal mining
how FDA should proceed. The Alabama Surface Mining Commission,
permits in Alabama.
comments that FDA receives in relation 1811 Second Ave., P.O. Box 2390,
This document gives the locations
to this public hearing may help inform Jasper, Alabama 35502–2390,
and times where the Alabama program
the further development of this Telephone: (205) 221–4130.
documents and proposed amendment to
approach. that program are available for your FOR FURTHER INFORMATION CONTACT:
inspection, establishes the comment William Joseph, Acting Director,
The document stated that comments
period during which you may submit Birmingham Field Office. Telephone:
would be accepted until January 15, (205) 290–7282, email: bjoseph@
2018, and that untimely comments written comments on the amendment,
and describes the procedures we will osmre.gov.
would not be considered. Near the end
of the comment period, we received a follow for the public hearing, if one is SUPPLEMENTARY INFORMATION:
request, submitted on behalf of several requested. I. Background on the Alabama Program
potential commenters, for more time to DATES: We will accept written II. Description of the Proposed Amendment
comments on this amendment until 4:00 III. Public Comment Procedures
develop comments. We have considered IV. Procedural Determinations
this request and are reopening the p.m., CST, February 21, 2018. If
comment period for an additional 30 requested, we will hold a public hearing
about the amendment on February 16, I. Background on the Alabama Program
days. We believe that this reopening
2018. We will accept requests to speak Section 503(a) of the Act permits a
allows adequate time for interested
at a hearing until 4:00 p.m., CST on State to assume primacy for the
persons to submit comments without regulation of surface coal mining and
February 6, 2018.
delaying further Agency efforts on this reclamation operations on non-Federal
ADDRESSES: You may submit comments,
topic. and non-Indian lands within its borders
identified by SATS No. AL–082–FOR,
Dated: January 16, 2018. by any of the following methods: by demonstrating that its program
Leslie Kux, • Mail/Hand Delivery: William includes, among other things, state laws
Associate Commissioner for Policy. Joseph, Acting Director, Birmingham and regulations that govern surface coal
Field Office, Office of Surface Mining mining and reclamation operations in
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[FR Doc. 2018–00991 Filed 1–19–18; 8:45 am]
Reclamation and Enforcement, 135 accordance with the Act and consistent
BILLING CODE 4164–01–P
Gemini Circle, Suite 215, Homewood, with the Federal regulations. See 30
Alabama 35209. U.S.C. 1253(a)(1) and (7). On the basis
• Fax: (205) 290–7280. of these criteria, the Secretary of the
• Federal eRulemaking Portal: The Interior conditionally approved the
amendment has been assigned Docket Alabama program effective May 20,
ID OSM–2017–0011. If you would like 1982. You can find background
to submit comments go to http:// information on the Alabama program,
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Document Created: 2018-01-23 21:35:43
Document Modified: 2018-01-23 21:35:43
| 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 | Proposed Rules | |
| Action | Notification of public hearing; reopening of the comment period. | |
| Dates | FDA is reopening the comment period on the document published on September 26, 2017 (82 FR 44803). Submit either electronic or written comments by February 21, 2018. | |
| Contact | John Barlow Weiner, Office of Combination Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993, 301-796-8930, [email protected] | |
| FR Citation | 83 FR 2952 |
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