81 FR 52444 - Over-the-Counter Monograph User Fees: Reopening of Comment Period; Stakeholder Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 152 (August 8, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 152 (August 8, 2016)
| Page Range | 52444-52445 | |
| FR Document | 2016-18717 |
[Federal Register Volume 81, Number 152 (Monday, August 8, 2016)] [Notices] [Pages 52444-52445] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-18717] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-1092] Over-the-Counter Monograph User Fees: Reopening of Comment Period; Stakeholder Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; reopening of comment period; stakeholder meeting. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is reopening the comment period for the document that announced a public meeting in the Federal Register of May 11, 2016. In the document, FDA invited public comment as the Agency considers a user-fee program for nonprescription (over-the-counter or OTC) monograph drugs. FDA will hold a Webinar for stakeholders on September 6, 2016. This Webinar is intended to be a followup to the June 10, 2016, public meeting on this topic and to provide stakeholders with a status update on the process of FDA and industry discussions that began in July 2016. DATES: Submit either electronic or written comments by October 6, 2016. FDA will hold a Webinar for stakeholders on Tuesday, September 6, 2016, from 10:30 a.m. to 12 p.m. EDT. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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 [[Page 52445]] 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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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-2016-N-1092 for ``Over-the-Counter Monograph User Fees: Reopening of Comment Period; Stakeholder Meeting.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov. Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Amy Bertha, Office of Executive Programs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-1647, email: [email protected]. SUPPLEMENTARY INFORMATION: I. Background FDA is reopening until October 6, 2016, the comment period for the document that announced a public meeting in the Federal Register of May 11, 2016 (81 FR 29275). In the document, FDA invited public comment as the Agency considers a user-fee program for nonprescription (over-the- counter or OTC) monograph drugs. A user-fee program would provide funding to supplement congressional non-user-fee appropriations, and would support timely and efficient FDA review of the efficacy and safety of ingredients included in or proposed for inclusion in a monograph. A public meeting on this topic was held on June 10, 2016, and interested persons were given until July 11, 2016, to submit comments. To ensure that all interested persons have sufficient opportunity to share their views on a potential OTC monograph user-fee program, FDA is reopening the comment period until October 6, 2016. FDA will hold a Webinar for stakeholders on September 6, 2016. This Webinar is intended to be a followup to the June 10, 2016, public meeting and provide stakeholders with a status update on the process of FDA and industry discussions that began in July 2016. Meeting minutes from these discussions can be found at: http://www.fda.gov/omuf. Additional background information on OTC monograph drugs (such as how OTC drugs can be marketed, the differences between marketing through approved applications and marketing under the monographs), factors FDA considers important in developing a user-fee program, and the questions FDA asked the public to consider and provide input, can be found in the Federal Register document from the June 10, 2106, public meeting (https://www.federalregister.gov/articles/2016/05/11/2016-11098/over-the-counter-monograph-user-fees-public-meeting-request-for-comments). The meeting transcript, meeting recording, and presentations from the June 10, 2016, public meeting, which can serve as further background information, can be found at: http://www.fda.gov/Drugs/NewsEvents/ucm499390.htm. II. Stakeholder Meeting Participation FDA is seeking participation at the Webinar by stakeholders, including scientific and academic experts, health care professionals, representatives of patient and consumer advocacy groups, and representatives of the OTC monograph industry. Participating in the Webinar is free. The Webinar format will include presentations by FDA staff and an opportunity for stakeholders to ask questions. If you wish to attend the Webinar, FDA asks that you please register through Eventbrite by Tuesday, August 30, 2016 (https://www.eventbrite.com/e/over-the-counter-monograph-user-fees-stakeholder-meeting-tickets-26751882601). FDA will email the registered attendees a URL to join the Webinar at least 1 day before the meeting. Dated August 3, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-18717 Filed 8-5-16; 8:45 am] BILLING CODE 4164-01-P
![52444 Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Notices
FOR FURTHER INFORMATION CONTACT: 807.81(a)(3) for submission and DEPARTMENT OF HEALTH AND
Michael Ryan, Center for Devices and clearance of a new 510(k). HUMAN SERVICES
Radiological Health, Food and Drug
II. Significance of Guidance Food and Drug Administration
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1615, Silver Spring, This draft guidance is being issued
[Docket No. FDA–2016–N–1092]
MD 20993–0002, 301–796–6283, consistent with FDA’s good guidance
michael.ryan@fda.hhs.gov; or Stephen practices regulation (21 CFR 10.115). Over-the-Counter Monograph User
Ripley, Center for Biologics Evaluation The draft guidance, when finalized, will Fees: Reopening of Comment Period;
and Research, Food and Drug represent the current thinking of FDA Stakeholder Meeting
Administration, 10903 New Hampshire on when to submit a 510(k) for a change
Ave., Bldg. 71, Rm. 7301, Silver Spring, to an existing device. It does not AGENCY: Food and Drug Administration,
MD 20993–0002, 240–402–7911. establish any rights for any person and HHS.
is not binding on FDA or the public. ACTION: Notice of public meeting;
SUPPLEMENTARY INFORMATION:
You can use an alternative approach if reopening of comment period;
I. Background it satisfies the requirements of the stakeholder meeting.
A premarket notification (510(k)) is applicable statutes and regulations.
SUMMARY: The Food and Drug
required when a legally marketed device III. Electronic Access Administration (FDA) is reopening the
subject to 510(k) requirements is about comment period for the document that
Persons interested in obtaining a copy
to be significantly changed or modified announced a public meeting in the
of the draft guidance may do so by
in design, components, method of Federal Register of May 11, 2016. In the
downloading an electronic copy from
manufacture, or intended use. document, FDA invited public comment
the Internet. A search capability for all
Significant changes or modifications are as the Agency considers a user-fee
Center for Devices and Radiological
those that could significantly affect the program for nonprescription (over-the-
Health guidance documents is available
safety or effectiveness of the device, or counter or OTC) monograph drugs. FDA
at http://www.fda.gov/MedicalDevices/
major changes or modifications in the will hold a Webinar for stakeholders on
DeviceRegulationandGuidance/
intended use of the device (21 CFR September 6, 2016. This Webinar is
GuidanceDocuments/default.htm.
807.81(a)(3)). This guidance, when intended to be a followup to the June
Guidance documents are also available
finalized, will aid manufacturers of 10, 2016, public meeting on this topic
at http://www.fda.gov/BiologicsBlood
medical devices who intend to modify and to provide stakeholders with a
Vaccines/GuidanceCompliance
a 510(k)-cleared device or a status update on the process of FDA and
RegulatoryInformation/default.htm or
preamendments device subject to 510(k) industry discussions that began in July
http://www.regulations.gov. Persons
(i.e., ‘‘existing devices’’) during the 2016.
unable to download an electronic copy
process of deciding whether the DATES: Submit either electronic or
of ‘‘Deciding When to Submit a 510(k)
modification exceeds the regulatory written comments by October 6, 2016.
for a Change to an Existing Device’’ may
threshold of 21 CFR 807.81(a)(3) for FDA will hold a Webinar for
send an email request to CDRH-
submission and clearance of a new stakeholders on Tuesday, September 6,
Guidance@fda.hhs.gov to receive an
510(k). 2016, from 10:30 a.m. to 12 p.m. EDT.
electronic copy of the document. Please
This guidance, when finalized, will ADDRESSES: You may submit comments
use the document number 1500054 to
supersede the original ‘‘Deciding When as follows:
identify the guidance you are
to Submit a 510(k) for a Change to an
requesting. Electronic Submissions
Existing Device,’’ issued on January 10,
1997. That guidance provided the IV. Paperwork Reduction Act of 1995 Submit electronic comments in the
Agency’s interpretation of whether the This draft guidance refers to following way:
modification exceeds the regulatory previously approved collections of • Federal eRulemaking Portal: http://
threshold of 21 CFR 807.81(a)(3), with information found in FDA regulations. www.regulations.gov. Follow the
principles and points for manufacturers These collections of information are instructions for submitting comments.
to consider in analyzing how changes in subject to review by the Office of Comments submitted electronically,
devices may affect safety or Management and Budget (OMB) under including attachments, to http://
effectiveness and determining whether a the Paperwork Reduction Act of 1995 www.regulations.gov will be posted to
new 510(k) must be submitted for a (44 U.S.C. 3501–3520). The collections the docket unchanged. Because your
particular type of change. This draft of information in 21 CFR part 820 are comment will be made public, you are
guidance preserves the basic format and approved under OMB control number solely responsible for ensuring that your
content of the original, with updates to 0910–0073; the collections of comment does not include any
add clarity. The added clarity is information in 21 CFR part 807, subpart confidential information that you or a
intended to increase consistent E are approved under OMB control third party may not wish to be posted,
interpretations of the guidance by FDA number 0910–0120; the collections of such as medical information, your or
staff and manufacturers. information in 21 CFR part 803 have anyone else’s Social Security number, or
Elsewhere in this issue of the Federal been approved under OMB control confidential business information, such
Register, FDA is announcing the number 0910–0437; and the collections as a manufacturing process. Please note
availability of the guidance document of information in 21 CFR parts 801 and that if you include your name, contact
entitled ‘‘Deciding When to Submit a information, or other information that
mstockstill on DSK3G9T082PROD with NOTICES
809 are approved under OMB control
510(k) for a Software Change to an number 0910–0485. identifies you in the body of your
Existing Device’’ to aid manufacturers of comments, that information will be
medical devices who intend to make Dated: August 2, 2016.
posted on http://www.regulations.gov.
software changes to an existing device Leslie Kux, • If you want to submit a comment
during the process of deciding whether Associate Commissioner for Policy. with confidential information that you
the software modification exceeds the [FR Doc. 2016–18713 Filed 8–5–16; 8:45 am] do not wish to be made available to the
regulatory threshold of 21 CFR BILLING CODE 4164–01–P public, submit the comment as a
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![Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Notices 52445
written/paper submission and in the regulatoryinformation/dockets/ input, can be found in the Federal
manner detailed (see ‘‘Written/Paper default.htm. Register document from the June 10,
Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to 2106, public meeting (https://
read background documents or the www.federalregister.gov/articles/2016/
Written/Paper Submissions electronic and written/paper comments 05/11/2016-11098/over-the-counter-
Submit written/paper submissions as received, go to http:// monograph-user-fees-public-meeting-
follows: www.regulations.gov and insert the request-for-comments). The meeting
• Mail/Hand delivery/Courier (for docket number, found in brackets in the transcript, meeting recording, and
written/paper submissions): Division of heading of this document, into the presentations from the June 10, 2016,
Dockets Management (HFA–305), Food ‘‘Search’’ box and follow the prompts public meeting, which can serve as
and Drug Administration, 5630 Fishers and/or go to the Division of Dockets further background information, can be
Lane, Rm. 1061, Rockville, MD 20852. Management, 5630 Fishers Lane, Rm. found at: http://www.fda.gov/Drugs/
• For written/paper comments 1061, Rockville, MD 20852. NewsEvents/ucm499390.htm.
submitted to the Division of Dockets FOR FURTHER INFORMATION CONTACT: II. Stakeholder Meeting Participation
Management, FDA will post your Amy Bertha, Office of Executive
comment, as well as any attachments, Programs, Center for Drug Evaluation FDA is seeking participation at the
except for information submitted, and Research, Food and Drug Webinar by stakeholders, including
marked and identified, as confidential, Administration, 10903 New Hampshire scientific and academic experts, health
if submitted as detailed in Ave., Silver Spring, MD 20993–0002, care professionals, representatives of
‘‘Instructions.’’ 301–796–1647, email: patient and consumer advocacy groups,
and representatives of the OTC
Instructions: All submissions received OTCMonographUserFeeProgram
monograph industry. Participating in
must include the Docket No. FDA– @fda.hhs.gov.
the Webinar is free. The Webinar format
2016–N–1092 for ‘‘Over-the-Counter SUPPLEMENTARY INFORMATION: will include presentations by FDA staff
Monograph User Fees: Reopening of and an opportunity for stakeholders to
Comment Period; Stakeholder Meeting.’’ I. Background
ask questions. If you wish to attend the
Received comments will be placed in FDA is reopening until October 6, Webinar, FDA asks that you please
the docket and, except for those 2016, the comment period for the register through Eventbrite by Tuesday,
submitted as ‘‘Confidential document that announced a public August 30, 2016 (https://
Submissions,’’ publicly viewable at meeting in the Federal Register of May www.eventbrite.com/e/over-the-counter-
http://www.regulations.gov or at the 11, 2016 (81 FR 29275). In the monograph-user-fees-stakeholder-
Division of Dockets Management document, FDA invited public comment meeting-tickets-26751882601). FDA will
between 9 a.m. and 4 p.m., Monday as the Agency considers a user-fee email the registered attendees a URL to
through Friday. program for nonprescription (over-the- join the Webinar at least 1 day before
• Confidential Submissions—To counter or OTC) monograph drugs. A the meeting.
submit a comment with confidential user-fee program would provide funding
Dated August 3, 2016.
information that you do not wish to be to supplement congressional non-user-
made publicly available, submit your fee appropriations, and would support Leslie Kux,
comments only as a written/paper timely and efficient FDA review of the Associate Commissioner for Policy.
submission. You should submit two efficacy and safety of ingredients [FR Doc. 2016–18717 Filed 8–5–16; 8:45 am]
copies total. One copy will include the included in or proposed for inclusion in BILLING CODE 4164–01–P
information you claim to be confidential a monograph. A public meeting on this
with a heading or cover note that states topic was held on June 10, 2016, and
‘‘THIS DOCUMENT CONTAINS interested persons were given until July DEPARTMENT OF HEALTH AND
CONFIDENTIAL INFORMATION.’’ The 11, 2016, to submit comments. To HUMAN SERVICES
Agency will review this copy, including ensure that all interested persons have
Food and Drug Administration
the claimed confidential information, in sufficient opportunity to share their
its consideration of comments. The views on a potential OTC monograph [Docket No. FDA–2015–N–1805]
second copy, which will have the user-fee program, FDA is reopening the
claimed confidential information comment period until October 6, 2016. Retrospective Review of Premarket
redacted/blacked out, will be available FDA will hold a Webinar for Approval Application Devices; Striking
for public viewing and posted on http:// stakeholders on September 6, 2016. This the Balance Between Premarket and
www.regulations.gov. Submit both Webinar is intended to be a followup to Postmarket Data Collection
copies to the Division of Dockets the June 10, 2016, public meeting and AGENCY: Food and Drug Administration,
Management. If you do not wish your provide stakeholders with a status HHS.
name and contact information to be update on the process of FDA and ACTION: Notice; request for comments.
made publicly available, you can industry discussions that began in July
provide this information on the cover 2016. Meeting minutes from these SUMMARY: The Food and Drug
sheet and not in the body of your discussions can be found at: http:// Administration (FDA) is announcing the
comments and you must identify this www.fda.gov/omuf. Additional completion of the target of the goal
information as ‘‘confidential.’’ Any background information on OTC established to address the Center for
information marked as ‘‘confidential’’ monograph drugs (such as how OTC Devices and Radiological Health’s
mstockstill on DSK3G9T082PROD with NOTICES
will not be disclosed except in drugs can be marketed, the differences (CDRH) 2014–2015 Strategic Priority
accordance with 21 CFR 10.20 and other between marketing through approved ‘‘Strike the Right Balance Between
applicable disclosure law. For more applications and marketing under the Premarket and Postmarket Data
information about FDA’s posting of monographs), factors FDA considers Collection.’’ To achieve this Strategic
comments to public dockets, see 80 FR important in developing a user-fee Priority, CDRH established a goal to
56469, September 18, 2015, or access program, and the questions FDA asked assure the appropriate balance between
the information at: http://www.fda.gov/ the public to consider and provide premarket and postmarket data
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Document Created: 2016-08-06 03:07:54
Document Modified: 2016-08-06 03:07:54
| 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 public meeting; reopening of comment period; stakeholder meeting. | |
| Dates | Submit either electronic or written comments by October 6, 2016. FDA will hold a Webinar for stakeholders on Tuesday, September 6, 2016, from 10:30 a.m. to 12 p.m. EDT. | |
| Contact | Amy Bertha, Office of Executive Programs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-1647, email: [email protected] | |
| FR Citation | 81 FR 52444 |
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