81 FR 7809 - Evaluation of the Safety of Drugs and Biological Products Used During Lactation; Public Workshop; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 30 (February 16, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 30 (February 16, 2016)
| Page Range | 7809-7810 | |
| FR Document | 2016-02967 |
[Federal Register Volume 81, Number 30 (Tuesday, February 16, 2016)] [Notices] [Pages 7809-7810] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-02967] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0437] Evaluation of the Safety of Drugs and Biological Products Used During Lactation; Public Workshop; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Evaluation of the Safety of Drugs and Biological Products used during Lactation.'' The purpose of this workshop is to provide a forum to discuss the current state and future directions of the collection of data on the potential risks to breastfed infants with maternal use of medications during lactation. The workshop will review current approaches to the collection of data when drugs are used or expected to be used during lactation. The workshop will also discuss and consider novel approaches to improve the quality and quantity of data, to inform of the potential risks of medication use during lactation, and to raise awareness and engage stakeholders about communication of safety information related to maternal use of medications during lactation. DATES: The public workshop will be held on April 27, 2016, from 8 a.m. to 5 p.m.; and April 28, 2016, from 8 a.m. to 1 p.m. Registration closes on April 8, 2016. Submit electronic or written comments to the public docket by May 28, 2016. ADDRESSES: The public workshop will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503A), Silver Spring, MD 20993-0002. Entrance for the public workshop participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. 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 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-0437 for ``Evaluation of the Safety of Drugs and Biological Products used during Lactation; Public Workshop; Request for Comments.'' 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 [[Page 7810]] 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: For questions regarding the workshop, contact Denise Pica-Branco, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-1732, FAX: 301-796-9858, [email protected]; or Denise Johnson-Lyles, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-6169; FAX: 301- 796-9858, [email protected]. Registration: Participation can be either in person attendance or by Webcast. There is no fee to attend the public workshop, but attendees must register in advance. Space is limited, and registration will be on a first-come, first-served basis. Persons interested in attending this workshop must register online at [email protected]. Please include: (1) First and last name, (2) contact phone or email address, (2) live attendance or via Webcast, (4) indicate if you plan to attend day 1, day 2, or both days. Registration closes on April 8, 2016. For those without Internet access, please contact Denise Pica- Branco or Denise Johnson-Lyles (see FOR FURTHER INFORMATION CONTACT) to register. Onsite registration will not be available. If you need special accommodations due to a disability, please contact Denise Pica-Branco or Denise Johnson-Lyles (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance. SUPPLEMENTARY INFORMATION: I. Background FDA has engaged with regulatory, academic, and industry experts to discuss the current state and future directions of the collection of data on the potential risks to breastfed infants with maternal use of medications during lactation. The first day of the workshop will focus on review and discussion of current approaches for the collection of data, and review and discussion of gaps in our present knowledge. The second day of the workshop will focus on consideration of novel approaches to improve the quality and quantity of data available to assess the safety of medications used during lactation as well as a review and discussion of strategies to communicate safety information related to maternal use of medications during lactation. This workshop includes a public comment session. If you would like to present during this session, please identify the topic(s) you will address during the registration. FDA will do its best accommodate requests to speak. FDA urges individuals and organizations with common interests to coordinate and give a joint, consolidated presentation. Following the close of registration, FDA will allot time for each presentation and notify presenters by April 21, 2016. Do not present or distribute commercial or promotional material during the workshop. Registered presenters should check in before the workshop begins. II. Transcripts Please be advised that as soon as a transcript is available, it will be accessible at http://www.regulations.gov. It may be viewed at the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20857. A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. The Freedom of Information office address is available on the Agency's Web site at http://www.fda.gov. Dated: February 9, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-02967 Filed 2-12-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 30 / Tuesday, February 16, 2016 / Notices 7809
enhance the safety and security of the Dated: February 9, 2016. You may submit comments as
pharmaceutical distribution supply Leslie Kux, follows:
chain. Stakeholders may comment on Associate Commissioner for Policy.
Electronic Submissions
utilizing the product identifier for [FR Doc. 2016–02977 Filed 2–12–16; 8:45 am]
product tracing and the technical BILLING CODE 4164–01–P
Submit electronic comments in the
capabilities of the pharmaceutical following way:
• Federal eRulemaking Portal: http://
distribution supply chain and the
DEPARTMENT OF HEALTH AND www.regulations.gov. Follow the
system attributes that are necessary to
HUMAN SERVICES instructions for submitting comments.
implement the requirements under Comments submitted electronically,
section 582. The information gathered including attachments, to http://
Food and Drug Administration
from the workshop participants and www.regulations.gov will be posted to
from the comments submitted to the [Docket No. FDA–2016–N–0437]
the docket unchanged. Because your
docket for the public workshop will comment will be made public, you are
Evaluation of the Safety of Drugs and
further inform FDA’s development of its solely responsible for ensuring that your
Biological Products Used During
pilot project program under section comment does not include any
Lactation; Public Workshop; Request
582(j) of the FD&C Act. for Comments confidential information that you or a
III. Registration for the Public third party may not wish to be posted,
AGENCY: Food and Drug Administration, such as medical information, your or
Workshop HHS. anyone else’s Social Security number, or
To request registration for the public ACTION: Notice of public workshop; confidential business information, such
workshop, provide your information request for comments. as a manufacturing process. Please note
including name, company or that if you include your name, contact
SUMMARY: The Food and Drug
organization, address, telephone information, or other information that
Administration (FDA) is announcing a
number, and email address to FDA at identifies you in the body of your
public workshop entitled ‘‘Evaluation of
http://www.fda.gov/Drugs/NewsEvents/ comments, that information will be
the Safety of Drugs and Biological
posted on http://www.regulations.gov.
ucm481767.htm. Registration requests Products used during Lactation.’’ The • If you want to submit a comment
should be received by March 11, 2016. purpose of this workshop is to provide with confidential information that you
FDA is limiting workshop attendance a forum to discuss the current state and
do not wish to be made available to the
due to limited space. FDA may limit the future directions of the collection of
public submit the comment as a written/
number of participants from each data on the potential risks to breastfed
paper submission and in the manner
organization based on space limitations. infants with maternal use of
detailed (see ‘‘Written/Paper
FDA recommends that each medications during lactation. The
Submissions’’ and ‘‘Instructions’’).
organization determine who should workshop will review current
register for the workshop to represent approaches to the collection of data Written/Paper Submissions
his/her organization. This will help when drugs are used or expected to be Submit written/paper submissions as
used during lactation. The workshop follows:
ensure that the workshop will have
will also discuss and consider novel • Mail/Hand delivery/Courier (for
broad and varied representation across
approaches to improve the quality and written/paper submissions): Division of
the pharmaceutical distribution supply quantity of data, to inform of the
chain. Registrants will receive Dockets Management (HFA–305), Food
potential risks of medication use during and Drug Administration, 5630 Fishers
confirmation of participation for the lactation, and to raise awareness and
workshop from FDA by March 18, 2016. Lane, Rm. 1061, Rockville, MD 20852.
engage stakeholders about • For written/paper comments
There is no registration fee for the communication of safety information submitted to the Division of Dockets
public workshop. There will be no related to maternal use of medications Management, FDA will post your
onsite registration. If registration during lactation. comment, as well as any attachments,
reaches maximum capacity, FDA will DATES: The public workshop will be except for information submitted,
post a notice closing registration for the held on April 27, 2016, from 8 a.m. to marked and identified, as confidential,
workshop on FDA’s Web site at http:// 5 p.m.; and April 28, 2016, from 8 a.m. if submitted as detailed in
www.fda.gov/Drugs/NewsEvents/ to 1 p.m. Registration closes on April 8, ‘‘Instructions.’’
ucm481767.htm. If you need special 2016. Submit electronic or written Instructions: All submissions received
accommodations due to a disability, comments to the public docket by May must include the Docket No. FDA–
please contact Daniel Bellingham (see 28, 2016. 2016–N–0437 for ‘‘Evaluation of the
FOR FURTHER INFORMATION CONTACT) at ADDRESSES: The public workshop will Safety of Drugs and Biological Products
least 7 days in advance of the public be held at FDA’s White Oak Campus, used during Lactation; Public
workshop. 10903 New Hampshire Ave., Bldg. 31 Workshop; Request for Comments.’’
Conference Center, the Great Room (Rm. Received comments will be placed in
IV. Webcasting of the Public Workshop 1503A), Silver Spring, MD 20993–0002. the docket and, except for those
Portions of this public workshop will Entrance for the public workshop submitted as ‘‘Confidential
be recorded and Webcasted on the day participants (non-FDA employees) is Submissions,’’ publicly viewable at
mstockstill on DSK4VPTVN1PROD with NOTICES
through Building 1 where routine http://www.regulations.gov or at the
of the workshop. Information for how to
security check procedures will be Division of Dockets Management
access the Webcast will be available at
performed. For parking and security between 9 a.m. and 4 p.m., Monday
http://www.fda.gov/Drugs/NewsEvents/ information, please refer to http:// through Friday.
ucm481767.htm by March 29, 2016. The www.fda.gov/AboutFDA/ • Confidential Submissions—To
Webcast will be conducted in listening- WorkingatFDA/BuildingsandFacilities/ submit a comment with confidential
mode only. WhiteOakCampusInformation/ information that you do not wish to be
ucm241740.htm. made publicly available submit your
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![7810 Federal Register / Vol. 81, No. 30 / Tuesday, February 16, 2016 / Notices
comments only as a written/paper include: (1) First and last name, (2) Information office address is available
submission. You should submit two contact phone or email address, (2) live on the Agency’s Web site at http://
copies total. One copy will include the attendance or via Webcast, (4) indicate www.fda.gov.
information you claim to be confidential if you plan to attend day 1, day 2, or Dated: February 9, 2016.
with a heading or cover note that states both days. Registration closes on April Leslie Kux,
‘‘THIS DOCUMENT CONTAINS 8, 2016. For those without Internet
Associate Commissioner for Policy.
CONFIDENTIAL INFORMATION.’’ The access, please contact Denise Pica-
Branco or Denise Johnson-Lyles (see FOR [FR Doc. 2016–02967 Filed 2–12–16; 8:45 am]
Agency will review this copy, including
the claimed confidential information, in FURTHER INFORMATION CONTACT) to BILLING CODE 4164–01–P
its consideration of comments. The register. Onsite registration will not be
second copy, which will have the available.
If you need special accommodations DEPARTMENT OF HEALTH AND
claimed confidential information
due to a disability, please contact HUMAN SERVICES
redacted/blacked out, will be available
for public viewing and posted on http:// Denise Pica-Branco or Denise Johnson-
Food and Drug Administration
www.regulations.gov. Submit both Lyles (see FOR FURTHER INFORMATION
copies to the Division of Dockets CONTACT) at least 7 days in advance. [Docket No. FDA–2007–D–0369]
Management. If you do not wish your SUPPLEMENTARY INFORMATION:
name and contact information to be Bioequivalence Recommendations for
I. Background Cyclosporine; Draft Guidance for
made publicly available, you can
provide this information on the cover FDA has engaged with regulatory, Industry; Availability
sheet and not in the body of your academic, and industry experts to
AGENCY: Food and Drug Administration,
comments and you must identify this discuss the current state and future
HHS.
information as ‘‘confidential.’’ Any directions of the collection of data on
the potential risks to breastfed infants ACTION: Notice of availability.
information marked as ‘‘confidential’’
will not be disclosed except in with maternal use of medications during SUMMARY: The Food and Drug
accordance with 21 CFR 10.20 and other lactation. The first day of the workshop Administration (FDA) is announcing the
applicable disclosure law. For more will focus on review and discussion of availability of a draft guidance for
information about FDA’s posting of current approaches for the collection of industry on cyclosporine ophthalmic
comments to public dockets, see 80 FR data, and review and discussion of gaps emulsion entitled ‘‘Draft Guidance on
56469, September 18, 2015, or access in our present knowledge. The second Cyclosporine.’’ The recommendations
the information at: http://www.fda.gov/ day of the workshop will focus on provide specific guidance on the design
regulatoryinformation/dockets/ consideration of novel approaches to of bioequivalence (BE) studies to
default.htm. improve the quality and quantity of data support abbreviated new drug
Docket: For access to the docket to available to assess the safety of applications (ANDAs) for cyclosporine
read background documents or the medications used during lactation as
ophthalmic emulsion. This draft
well as a review and discussion of
electronic and written/paper comments guidance is a revised version of a
strategies to communicate safety
received, go to http:// previously issued draft guidance on the
information related to maternal use of
www.regulations.gov and insert the same subject.
medications during lactation.
docket number, found in brackets in the This workshop includes a public DATES: Although you can comment on
heading of this document, into the comment session. If you would like to any guidance at any time (see 21 CFR
‘‘Search’’ box and follow the prompts present during this session, please 10.115(g)(5)), to ensure that the Agency
and/or go to the Division of Dockets identify the topic(s) you will address considers your comments on this draft
Management, 5630 Fishers Lane, Rm. during the registration. FDA will do its guidance before it begins work on the
1061, Rockville, MD 20852. best accommodate requests to speak. final version of the guidance, submit
FOR FURTHER INFORMATION CONTACT: For FDA urges individuals and either electronic or written comments
questions regarding the workshop, organizations with common interests to on the draft guidance by April 18, 2016.
contact Denise Pica-Branco, Center for coordinate and give a joint, consolidated ADDRESSES: You may submit comments
Drug Evaluation and Research, Food presentation. Following the close of as follows:
and Drug Administration, 10903 New registration, FDA will allot time for each
Hampshire Ave., Silver Spring, MD Electronic Submissions
presentation and notify presenters by
20993–0002, 301–796–1732, FAX: 301– April 21, 2016. Do not present or Submit electronic comments in the
796–9858, denise.picabranco@ distribute commercial or promotional following way:
fda.hhs.gov; or Denise Johnson-Lyles, material during the workshop. • Federal eRulemaking Portal: http://
Center for Drug Evaluation and Registered presenters should check in www.regulations.gov. Follow the
Research, Food and Drug before the workshop begins. instructions for submitting comments.
Administration, 10903 New Hampshire Comments submitted electronically,
Ave., Silver Spring, MD 20993–0002, II. Transcripts including attachments, to http://
301–796–6169; FAX: 301–796–9858, Please be advised that as soon as a www.regulations.gov will be posted to
denise.johnson-lyles@fda.hhs.gov. transcript is available, it will be the docket unchanged. Because your
Registration: Participation can be accessible at http:// comment will be made public, you are
mstockstill on DSK4VPTVN1PROD with NOTICES
either in person attendance or by www.regulations.gov. It may be viewed solely responsible for ensuring that your
Webcast. There is no fee to attend the at the Division of Dockets Management, comment does not include any
public workshop, but attendees must Food and Drug Administration, 5630 confidential information that you or a
register in advance. Space is limited, Fishers Lane, Rm. 1061, Rockville, MD third party may not wish to be posted,
and registration will be on a first-come, 20857. A transcript will also be such as medical information, your or
first-served basis. Persons interested in available in either hardcopy or on CD– anyone else’s Social Security number, or
attending this workshop must register ROM, after submission of a Freedom of confidential business information, such
online at lactation@fda.hhs.gov. Please Information request. The Freedom of as a manufacturing process. Please note
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Document Created: 2016-02-13 03:13:28
Document Modified: 2016-02-13 03:13:28
| 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 workshop; request for comments. | |
| Dates | The public workshop will be held on April 27, 2016, from 8 a.m. to 5 p.m.; and April 28, 2016, from 8 a.m. to 1 p.m. Registration closes on April 8, 2016. Submit electronic or written comments to the public docket by May 28, 2016. | |
| Contact | For questions regarding the workshop, contact Denise Pica-Branco, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-1732, FAX: 301-796-9858, [email protected]; or Denise Johnson-Lyles, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-6169; FAX: 301- 796-9858, [email protected] | |
| FR Citation | 81 FR 7809 |
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