81 FR 75419 - Labeling for Permanent Hysteroscopically Placed Tubal Implants Intended for Sterilization; Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 210 (October 31, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 210 (October 31, 2016)
| Page Range | 75419-75421 | |
| FR Document | 2016-26243 |
[Federal Register Volume 81, Number 210 (Monday, October 31, 2016)] [Notices] [Pages 75419-75421] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-26243] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-0435] Labeling for Permanent Hysteroscopically Placed Tubal Implants Intended for Sterilization; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization.'' This guidance addresses the inclusion of a boxed warning and patient decision checklist in the product labeling for permanent hysteroscopically placed tubal implants intended for female sterilization, and the content and format of those materials. FDA believes that the labeling described in this guidance will help to ensure that a woman receives and understands information regarding the benefits and risks of this type of device prior to undergoing implantation. FDA considered comments received on the draft guidance and revised the guidance as appropriate. The guidance identifies the content and format of certain labeling components for permanent, hysteroscopically placed tubal implants that are intended for sterilization. The guidance applies to all devices of this type, regardless of the insert material composition, location of intended implantation, or exact method of delivery. DATES: Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. 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 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-D-0435 for ``Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization, Guidance for Industry and Food and Drug Administration Staff.'' 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 [[Page 75420]] 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. An electronic copy of the guidance document is available for download from the Internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the guidance document entitled ``Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization, Guidance for Industry and Food and Drug Administration Staff'' to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request. FOR FURTHER INFORMATION CONTACT: Jason Roberts, Division of Reproductive, Gastro-Renal and Urological Devices, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G218, Silver Spring, MD 20993-0002, 240- 402-6400. SUPPLEMENTARY INFORMATION: I. Background Female sterilization is a commonly performed surgical procedure that permanently prevents a woman from becoming pregnant by occluding her fallopian tubes. Traditionally, such surgery has been performed by surgical bilateral tubal ligation (BTL) through a laparotomy, a mini- laparotomy, a transvaginal approach or at the time of cesarean delivery, and, more recently, laparoscopy. During surgical BTL, the fallopian tubes are cut or physically occluded by using various procedures or medical instruments, such as electrosurgical coagulation or implantable clips or rings. On November 4, 2002, FDA approved the Essure System for Permanent Birth Control, the first permanent hysteroscopically placed tubal implant, as an alternative, non- incisional method of providing female sterilization. As the number of hysteroscopic sterilizations with such devices has increased, additional information, including reports of adverse events, has accumulated. Some of these events have resulted in surgery and/or removal of the implants. In the Federal Register on July 22, 2015 (80 FR 43440), FDA announced a meeting of a public advisory committee to seek expert scientific and clinical opinion on the risks and benefits of the Essure System for Permanent Birth Control. On September 24, 2015, FDA convened its Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee to discuss available data regarding benefits, risks, and potential mitigation strategies to prevent or reduce the frequency/ severity of the adverse events reported in association with this device (Ref. 1). A draft guidance regarding the labeling for permanent hysteroscopically placed tubal implants intended for sterilization was announced in the Federal Register on March 4, 2016 (81 FR 11577) and made available for public comment. The comment period closed on May 3, 2016. FDA reviewed and considered all public comments received and revised the guidance as appropriate, including revisions to the content and format of a boxed warning and patient decision checklist. FDA intends to require such labeling as part of a premarket approval application (PMA) for hysteroscopically placed tubal implants intended for sterilization (or a PMA supplement for an already marketed device). II. Significance of Guidance This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ``Labeling for Permanent Hysteroscopically- Placed Tubal Implants Intended for Sterilization.'' It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. III. Electronic Access Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the Internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at http://www.regulations.gov. Persons unable to download an electronic copy of ``Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization'' may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1500051 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485. V. References The following reference is on display in the Division of Dockets Management (see ADDRESSES) and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at http://www.regulations.gov. FDA has verified the Web site address, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. 1. Meeting Materials of the Obstetrics and Gynecology Devices Panel (2015), available at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ObstetricsandGynecologyDevices/ucm463457.htm. [[Page 75421]] Dated: October 26, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-26243 Filed 10-28-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 210 / Monday, October 31, 2016 / Notices 75419
TABLE 9—SUMMARY OF STATUS OF POSTMARKETING COMMITMENTS ESTABLISHED BETWEEN FY 2008 AND FY 2014 1 2
[Numbers as of September 30, 2014] 3
PMC status as of Fiscal year of PMC establishment
FY2014
(% of total PMCs in
each establishment 2008 2009 2010 2011 2012 2013 2014
year)
Pending ........................ 1 (1%) 4 (9%) 3 (3%) 11 (13%) 12 (23%) 22 (45%) 47 (82%)
Ongoing ........................ 11 (9%) 5 (11%) 16 (18%) 25 (30%) 16 (30%) 14 (29%) 9 (16%)
Submitted ..................... 1 (1%) 6 (13%) 9 (10%) 2 (2%) 5 (9%) 6 (12%) 0
Delayed ........................ 8 (7%) 8 (17%) 16 (18%) 8 (10%) 6 (11%) 3 (6%) 0
Terminated ................... 0 1 (2%) 0 0 0 0 0
Released ...................... 12 (10%) 3 (6%) 6 (7%) 7 (9%) 0 0 0
Fulfilled ......................... 86 (72%) 20 (43%) 40 (44%) 29 (35%) 14 (26%) 4 (8%) 1 (2%)
Total ...................... 119 47 90 82 53 49 57
1 The establishment date is the date of the formal FDA communication to the applicant that included the final FDA required (PMR) or requested
(PMC) postmarketing study or clinical trial.
2 The table shows data for PMCs that were closed (fulfilled or released) as of FY2014. Therefore, data for PMCs that were closed in prior fiscal
years are included.
3 Percentages may not total 100 due to rounding.
Dated: October 25, 2016. The guidance identifies the content public, submit the comment as a
Leslie Kux, and format of certain labeling written/paper submission and in the
Associate Commissioner for Policy. components for permanent, manner detailed (see ‘‘Written/Paper
[FR Doc. 2016–26247 Filed 10–28–16; 8:45 am] hysteroscopically placed tubal implants Submissions’’ and ‘‘Instructions’’).
that are intended for sterilization. The
BILLING CODE 4164–01–P Written/Paper Submissions
guidance applies to all devices of this
type, regardless of the insert material Submit written/paper submissions as
DEPARTMENT OF HEALTH AND composition, location of intended follows:
HUMAN SERVICES implantation, or exact method of • Mail/Hand delivery/Courier (for
delivery. written/paper submissions): Division of
Food and Drug Administration Dockets Management (HFA–305), Food
DATES: Submit either electronic or and Drug Administration, 5630 Fishers
written comments on this guidance at Lane, Rm. 1061, Rockville, MD 20852.
[Docket No. FDA–2016–D–0435] any time. General comments on Agency • For written/paper comments
guidance documents are welcome at any submitted to the Division of Dockets
Labeling for Permanent time.
Hysteroscopically Placed Tubal Management, FDA will post your
Implants Intended for Sterilization; ADDRESSES: You may submit comments comment, as well as any attachments,
Guidance for Industry and Food and as follows: except for information submitted,
Drug Administration Staff; Availability marked and identified, as confidential,
Electronic Submissions
if submitted as detailed in
AGENCY: Food and Drug Administration, Submit electronic comments in the ‘‘Instructions.’’
HHS. following way: Instructions: All submissions received
ACTION: Notice of availability. • Federal eRulemaking Portal: http:// must include the Docket No. FDA–
www.regulations.gov. Follow the 2016–D–0435 for ‘‘Labeling for
SUMMARY: The Food and Drug instructions for submitting comments. Permanent Hysteroscopically-Placed
Administration (FDA or Agency) is Comments submitted electronically, Tubal Implants Intended for
announcing the availability of the including attachments, to http:// Sterilization, Guidance for Industry and
guidance entitled ‘‘Labeling for www.regulations.gov will be posted to Food and Drug Administration Staff.’’
Permanent Hysteroscopically-Placed the docket unchanged. Because your Received comments will be placed in
Tubal Implants Intended for comment will be made public, you are the docket and, except for those
Sterilization.’’ This guidance addresses solely responsible for ensuring that your submitted as ‘‘Confidential
the inclusion of a boxed warning and comment does not include any Submissions,’’ publicly viewable at
patient decision checklist in the product confidential information that you or a http://www.regulations.gov or at the
labeling for permanent third party may not wish to be posted, Division of Dockets Management
hysteroscopically placed tubal implants such as medical information, your or between 9 a.m. and 4 p.m., Monday
intended for female sterilization, and anyone else’s Social Security number, or through Friday.
the content and format of those confidential business information, such • Confidential Submissions—To
materials. FDA believes that the labeling as a manufacturing process. Please note submit a comment with confidential
described in this guidance will help to that if you include your name, contact information that you do not wish to be
sradovich on DSK3GMQ082PROD with NOTICES
ensure that a woman receives and information, or other information that made publicly available, submit your
understands information regarding the identifies you in the body of your comments only as a written/paper
benefits and risks of this type of device comments, that information will be submission. You should submit two
prior to undergoing implantation. FDA posted on http://www.regulations.gov. copies total. One copy will include the
considered comments received on the • If you want to submit a comment information you claim to be confidential
draft guidance and revised the guidance with confidential information that you with a heading or cover note that states
as appropriate. do not wish to be made available to the ‘‘THIS DOCUMENT CONTAINS
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![Federal Register / Vol. 81, No. 210 / Monday, October 31, 2016 / Notices 75421
Dated: October 26, 2016. Contact Person: Richard Ingraham, Ph.D., Time: 1:00 p.m. to 4:00 p.m.
Leslie Kux, Scientific Review Officer, Center for Agenda: To review and evaluate grant
Associate Commissioner for Policy. Scientific Review, National Institutes of applications.
Health, 6701 Rockledge Drive, Room 4116, Place: National Institutes of Health, 6701
[FR Doc. 2016–26243 Filed 10–28–16; 8:45 am] MSC 7814, Bethesda, MD 20892, 301–496– Rockledge Drive, Bethesda, MD 20892
BILLING CODE 4164–01–P 8551, ingrahamrh@mail.nih.gov. (Telephone Conference Call).
Name of Committee: Center for Scientific Contact Person: Christine A Piggee, Ph.D.,
Review Special Emphasis Panel; Small Scientific Review Officer, Center for
DEPARTMENT OF HEALTH AND Business: Neuroscience Assay, Diagnostics Scientific Review, National Institutes of
HUMAN SERVICES and Animal Model Development. Health, 6701 Rockledge Drive, Room 4186,
Date: November 29, 2016. MSC 7850, Bethesda, MD 20892, 301–435–
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16th Street NW., Washington, DC 20006. Date: November 30, 2016.
Pursuant to section 10(d) of the Contact Person: Susan Gillmor, Ph.D., Time: 1:00 p.m. to 3:00 p.m.
Federal Advisory Committee Act, as Scientific Review Officer, National Institutes Agenda: To review and evaluate grant
amended (5 U.S.C. App.), notice is of Health, Center for Scientific Review, 6701 applications.
hereby given of the following meetings. Rockledge Drive, Bethesda, MD 20892, 301– Place: National Institutes of Health, 6701
The meetings will be closed to the 435–1730, susan.gillmor@nih.gov. Rockledge Drive, Bethesda, MD 20892
public in accordance with the Name of Committee: Center for Scientific (Virtual Meeting).
provisions set forth in sections Review Special Emphasis Panel; Small Contact Person: Wind Cowles, Ph.D.,
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Business: Nephrology. Scientific Review Officer, Center for
Date: November 29–30, 2016. Scientific Review, National Institutes of
as amended. The grant applications and
Time: 9:00 a.m. to 6:00 p.m. Health, 6701 Rockledge Drive, Room 3172,
the discussions could disclose Agenda: To review and evaluate grant Bethesda, MD 20892, cowleshw@csr.nih.gov.
confidential trade secrets or commercial applications. (Catalogue of Federal Domestic Assistance
property such as patentable material, Place: National Institutes of Health, 6701 Program Nos. 93.306, Comparative Medicine;
and personal information concerning Rockledge Drive, Bethesda, MD 20892 93.333, Clinical Research, 93.306, 93.333,
individuals associated with the grant (Virtual Meeting). 93.337, 93.393–93.396, 93.837–93.844,
applications, the disclosure of which Contact Person: Atul Sahai, Ph.D., 93.846–93.878, 93.892, 93.893, National
would constitute a clearly unwarranted Scientific Review Officer, Center for Institutes of Health, HHS)
invasion of personal privacy. Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2188, Dated: October 25, 2016.
Name of Committee: Center for Scientific MSC 7818, Bethesda, MD 20892, 301–435– Natasha M. Copeland,
Review Special Emphasis Panel; Small 1198, sahaia@csr.nih.gov. Program Analyst, Office of Federal Advisory
Business: Cell and Molecular Biology. Name of Committee: Center for Scientific Committee Policy.
Date: November 16–17, 2016.
Review Special Emphasis Panel; Biological [FR Doc. 2016–26128 Filed 10–28–16; 8:45 am]
Time: 8:00 a.m. to 5:00 p.m.
Chemistry and Macromolecular Biophysics.
Agenda: To review and evaluate grant BILLING CODE 4140–01–P
Date: November 29, 2016.
applications.
Time: 1:30 p.m. to 5:00 p.m.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road NW., Agenda: To review and evaluate grant
applications. DEPARTMENT OF HEALTH AND
Washington, DC 20015. HUMAN SERVICES
Contact Person: Amy Kathleen Wernimont, Place: National Institutes of Health, 6701
Ph.D., Scientific Review Officer, Center for Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call). National Institutes of Health
Scientific Review, 6701 Rockledge Drivem
Bethesda, MD 20892, 301–827–6427, Contact Person: William A Greenberg,
Ph.D., Scientific Review Officer, Center for Government-Owned Inventions;
amy.wernimont@nih.gov.
Scientific Review, National Institutes of Availability for Licensing
Name of Committee: Center for Scientific
Health, 6701 Rockledge Drive, Room 4168,
Review Special Emphasis Panel; PAR Panel: AGENCY: National Institutes of Health,
MSC 7806, Bethesda, MD 20892, (301) 435–
Studies of HIV/AIDS and Aging. HHS.
1726, greenbergwa@csr.nih.gov.
Date: November 21, 2016.
Time: 10:00 a.m. to 5:00 p.m. Name of Committee: Center for Scientific ACTION: Notice.
Agenda: To review and evaluate grant Review Special Emphasis Panel; Small
applications. Business: Psycho/Neuropathology, Lifespan SUMMARY: The invention listed below is
Place: National Institutes of Health, 6701 Development, and STEM Education. owned by an agency of the U.S.
Rockledge Drive, Bethesda, MD 20892 Date: November 29, 2016. Government and is available for
(Virtual Meeting). Time: 12:00 p.m. to 6:00 p.m. licensing and/or co-development in the
Contact Person: Robert Freund, Ph.D., Agenda: To review and evaluate grant
U.S. in accordance with 35 U.S.C. 209
Scientific Review Officer, Center for applications.
Place: National Institutes of Health, 6701 and 37 CFR part 404 to achieve
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5216, Rockledge Drive, Bethesda, MD 20892 expeditious commercialization of
MSC 7852, Bethesda, MD 20892, 301–435– (Virtual Meeting). results of federally-funded research and
1050, freundr@csr.nih.gov. Contact Person: John H Newman, Ph.D., development. Foreign patent
Name of Committee: Center for Scientific Scientific Review Officer, Center for applications are filed on selected
Review Special Emphasis Panel; Scientific Review, National Institutes of inventions to extend market coverage
sradovich on DSK3GMQ082PROD with NOTICES
Musculoskeletal, Oral and Skin Sciences Health, 6701 Rockledge Drive, Room 3222, for companies and may also be available
Continuous Submission. MSC 7808, Bethesda, MD 20892, (301) 435– for licensing and/or co-development.
Date: November 21, 2016. 0628, newmanjh@csr.nih.gov.
ADDRESSES: Invention Development and
Time: 1:00 p.m. to 4:30 p.m. Name of Committee: Center for Scientific
Agenda: To review and evaluate grant Review Special Emphasis Panel; Member Marketing Unit, Technology Transfer
applications. Conflict: Molecular Cellular Developmental Center, National Cancer Institute, 9609
Place: National Institutes of Health, 6701 Neuroscience. Medical Center Drive, Mail Stop 9702,
Rockledge Drive, Bethesda, MD 20892. Date: November 30, 2016. Rockville, MD 20850–9702.
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Document Created: 2018-02-02 12:13:25
Document Modified: 2018-02-02 12:13:25
| 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. | |
| Dates | Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. | |
| Contact | Jason Roberts, Division of Reproductive, Gastro-Renal and Urological Devices, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G218, Silver Spring, MD 20993-0002, 240- 402-6400. | |
| FR Citation | 81 FR 75419 |
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