81 FR 11577 - Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization, Draft Guidance for Industry and Food and Drug Administration Staff; Availability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 43 (March 4, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 43 (March 4, 2016)
| Page Range | 11577-11579 | |
| FR Document | 2016-04790 |
[Federal Register Volume 81, Number 43 (Friday, March 4, 2016)] [Notices] [Pages 11577-11579] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-04790] ----------------------------------------------------------------------- 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[Docket No. FDA-2016-D-0435] Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization, Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization.'' This draft guidance addresses the inclusion of a boxed warning and a patient decision checklist in the product labeling for permanent hysteroscopically-placed tubal implants intended for female sterilization and as well as the content and format of those materials. This draft guidance is being issued in response to information provided to FDA, including in comments made at a 2015 Panel meeting and in comments submitted to the associated public docket, that women are not receiving or understanding information relating to the risks and benefits of this type of device. This draft [[Page 11578]] guidance is not final nor is it in effect at this time. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 3, 2016. 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.'' 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. Submit written requests for a single copies of the guidance 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. See SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. 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, surgery has been performed by bilateral tubal ligation (BTL) through a laparotomy, a mini-laparotomy, transvaginal approach or at the time of cesarean delivery, and, more recently, laparoscopy. During BTL, the fallopian tubes are cut or physically occluded by using various procedures or medical instruments, such as electrosurgical coagulation, 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. The Federal Register on July 22, 2015 (80 FR 43440), announced a meeting of a public advisory committee of the FDA 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). FDA is issuing this draft guidance document after considering the input of the Panel members and other stakeholders. FDA believes that the labeling described in this guidance will help to ensure that women are receiving and understanding information about the risks and benefits of these devices so that they can make informed decisions regarding use of these devices. In addition to issuing this guidance, FDA continues to determine what, if any, further actions are warranted in response to these reported adverse events. [[Page 11579]] II. Significance of Guidance This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ``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 draft 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 draft 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. Reference 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 are 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. Dated: February 29, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-04790 Filed 3-3-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 43 / Friday, March 4, 2016 / Notices 11577
States’’). The evidence required by qualifying for the small business fee groups/fdagov-public/@fdagov-meddev-
MDUFMA is a copy of the most recent rates. Thus, foreign governments, gen/documents/document/
Federal income tax return of the including the European Union, have ucm456779.pdf. This guidance
applicant, and any affiliate, partner, or objected. In lieu of a Federal income tax describes the criteria FDA will use to
parent firm. FDA will review these return, the 2007 Amendments will decide whether an entity qualifies as a
materials and decide whether an allow a foreign business to qualify as a MDUFMA small business and will help
applicant is a small business within the small business by submitting a prospective applicants understand what
meaning of MDUFMA. certification from its national taxing they need to do to meet the small
The 2007 Amendments provide an authority, the foreign equivalent of our business criteria for FY 2016.
alternative way for a foreign business to Internal Revenue Service. This The estimated burden is based on the
qualify as a small business eligible to certification, referred to as a ‘‘National number of applications received in the
pay a significantly lower fee when a Taxing Authority Certification,’’ must: last 3 years and includes time required
medical device user fee must be paid (1) Be in English; (2) be from the to collect the required information.
(Form FDA 3602A, ‘‘FY 2016 MDUFMA national taxing authority of the country Based on our experience with Form
Foreign Small Business Qualification in which the business is headquartered; FDA 3602, FDA believes it will take
Certification—For a Business (3) provide the business’ gross receipts each respondent 1 hour to complete the
Headquartered Outside the United or sales for the most recent year, in both form. Based on our experience with
States’’). Before passage of the 2007 the local currency and in U.S. dollars, Form FDA 3602A, FDA also believes
Amendments, the only way a business and the exchange rate used in that it will take each respondent 1 hour
could qualify as a small business was to converting local currency to U.S. to complete.
submit a Federal (U.S.) income tax dollars; (4) provide the dates during
return showing its gross receipts or sales which the reported receipts or sales In the Federal Register of September
that did not exceed a statutory were collected; and (5) bear the official 17, 2015 (80 FR 55854), FDA published
threshold, currently, $100 million. If a seal of the national taxing authority. a 60-day notice requesting public
business could not provide a Federal Both Forms FDA 3602 and FDA comment on the proposed collection of
income tax return, it did not qualify as 3602A are available in the guidance information. Although one comment
a small business and had to pay the document, ‘‘FY 2016 Medical Device was received, it was not responsive to
standard (full) fee. Because many User Fee Small Business Qualification the four collection of information topics
foreign businesses have not, and cannot, and Certification; Guidance for Industry, solicited and therefore will not be
file a Federal (U.S.) income tax return, Food and Drug Administration Staff, discussed in this document.
this requirement has effectively and Foreign Governments’’ available on FDA estimates the burden of this
prevented those businesses from the Internet at: http://www.fda.gov/ucm/ collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
FDA Form No. responses per burden per Total hours
respondents responses
respondent response
FDA 3602—FY 2016 MDUFA Small Business Qualification
and Certification For a Business Headquartered in the
United States .................................................................... 3,600 1 3,600 1 3,600
FDA 3602A—FY 2016 MDUFA Foreign Small Business
Qualification and Certification For a Business
Headquartered Outside the United States ....................... 1,400 1 1,400 1 1,400
Total .............................................................................. ........................ ........................ ........................ ........................ 5,000
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: February 29, 2016. DEPARTMENT OF HEALTH AND guidance entitled ‘‘Labeling for
Leslie Kux, HUMAN SERVICES Permanent Hysteroscopically-Placed
Associate Commissioner for Policy. Tubal Implants Intended for
Food and Drug Administration Sterilization.’’ This draft guidance
[FR Doc. 2016–04704 Filed 3–3–16; 8:45 am]
BILLING CODE 4164–01–P
addresses the inclusion of a boxed
[Docket No. FDA–2016–D–0435]
warning and a patient decision checklist
Labeling for Permanent in the product labeling for permanent
Hysteroscopically-Placed Tubal hysteroscopically-placed tubal implants
Implants Intended for Sterilization, intended for female sterilization and as
Draft Guidance for Industry and Food well as the content and format of those
and Drug Administration Staff; materials. This draft guidance is being
Availability issued in response to information
jstallworth on DSK7TPTVN1PROD with NOTICES
provided to FDA, including in
AGENCY: Food and Drug Administration, comments made at a 2015 Panel meeting
HHS.
and in comments submitted to the
ACTION: Notice of availability. associated public docket, that women
SUMMARY: The Food and Drug are not receiving or understanding
Administration (FDA or Agency) is information relating to the risks and
announcing the availability of the draft benefits of this type of device. This draft
VerDate Sep<11>2014 15:22 Mar 03, 2016 Jkt 238001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 E:\FR\FM\04MRN1.SGM 04MRN1](https://thefederalregister.org/doc/81_FR_11620/page/1.svg)
![Federal Register / Vol. 81, No. 43 / Friday, March 4, 2016 / Notices 11579
II. Significance of Guidance www.fda.gov/AdvisoryCommittees/ maintaining recovery; and a reduction
This draft guidance is being issued CommitteesMeetingMaterials/ in the number of deaths from opioid
consistent with FDA’s good guidance MedicalDevices/MedicalDevices overdose.
practices regulation (21 CFR 10.115). AdvisoryCommittee/Obstetricsand DATES: The challenge starts on March 4,
The draft guidance, when finalized, will GynecologyDevices/ 2016 10:00 a.m. ET. The challenge ends
represent the current thinking of FDA ucm463457.htm. on May 27, 2016 11:59 p.m. ET.
on ‘‘Labeling for Permanent Dated: February 29, 2016. FOR FURTHER INFORMATION CONTACT:
Hysteroscopically-Placed Tubal Leslie Kux, Danielle Tarino Rivkin, Health
Implants Intended for Sterilization.’’ It Associate Commissioner for Policy. Information Technology Team, Center
does not establish any rights for any [FR Doc. 2016–04790 Filed 3–3–16; 8:45 am] for Substance Abuse Treatment,
person and is not binding on FDA or the BILLING CODE 4164–01–P Substance Abuse and Mental Health
public. You can use an alternative Services Administration, U.S.
approach if it satisfies the requirements Department of Health and Human
of the applicable statutes and DEPARTMENT OF HEALTH AND Services, Public Health Advisor,
regulations. HUMAN SERVICES SAMHSA/CSAT, 5600 Fishers Lane,
III. Electronic Access Rockville, MD 20857, Phone:
Substance Abuse and Mental Health 240.276.2857, Email: Danielle.Tarino@
Persons interested in obtaining a copy Services Administration samhsa.hhs.gov.
of the draft guidance may do so by
downloading an electronic copy from Announcement of Requirements and SUPPLEMENTARY INFORMATION:
the Internet. A search capability for all Registration for the Opioid Overdose Subject of Challenge Competition:
Center for Devices and Radiological Prevention Challenge Opioid Recovery Support.
Health guidance documents is available Eligibility Rules for Participating in the
at http://www.fda.gov/MedicalDevices/ Authority: 15 U.S.C. 3719.
Competition
DeviceRegulationandGuidance/ AGENCY: SAMHSA, HHS.
GuidanceDocuments/default.htm. To satisfy the mandatory provisions of
ACTION: Notice.
Guidance documents are also available the COMPETES Act, use the following
at http://www.regulations.gov. Persons SUMMARY: In summarizing the challenge language:
unable to download an electronic copy that will be issued by your agency, A. The Competition is open only to:
of ‘‘Labeling for Permanent please answer the following four (i) Individuals who are at least 18
Hysteroscopically-Placed Tubal questions: years of age at the time of entry, and are
Implants Intended for Sterilization’’ (1) What action is being taken? citizens or permanent residents of the
may send an email request to CDRH- The Substance Abuse and Mental United States as of the time of entry;
Guidance@fda.hhs.gov to receive an Health Services Administration (ii) teams of eligible individuals
electronic copy of the document. Please (SAMHSA) has issued a challenge to where each team member meets the
use the document number 1500051 to developers to help support patients in eligibility requirements for individual
identify the guidance you are recovery who are receiving medication Contestants; and
requesting. assisted treatment for opioid use (iii) corporations (including not-for-
disorder with an innovative app that profit corporations and other nonprofit
IV. Paperwork Reduction Act of 1995 organizations), limited liability
provides features and information that
This draft guidance refers to support their recovery. companies, partnerships, and other legal
previously approved collections of (2) Why is this action necessary? entities that, at the time of entry, are
information found in FDA regulations. Addressing the opioid epidemic is a domiciled (or incorporated) in the
These collections of information are top priority for the U.S. Department of United States, have been duly organized
subject to review by the Office of Health and Human Services and the or incorporated and validly exist, and
Management and Budget (OMB) under Secretary is committed to evidence- employ no more than one hundred (100)
the Paperwork Reduction Act of 1995 informed interventions to turn the tide people (‘‘Organizations’’).
(44 U.S.C. 3501–3520). The collections against opioid drug-related overdose B. Each team or Organization shall
of information in 21 CFR part 801, and misuse. To that end, Substance appoint one individual (the
regarding labeling have been approved Abuse and Mental Health Services ‘‘Representative’’) to represent and act,
under OMB control number 0910–0485. Administration (SAMHSA) is issuing a including entering a Submission, on
V. Reference three-month challenge to spur behalf of said team or Organization. The
developers to create an app that Representative must meet the eligibility
The following reference is on display provides additional recovery support to requirements for an individual
in the Division of Dockets Management patients receiving outpatient Contestant and must be duly authorized
(see ADDRESSES) and is available for medication-assisted treatment for opioid to submit on behalf of the team or
viewing by interested persons between use disorder. Organization. The Representative
9 a.m. and 4 p.m., Monday through (3) What is the objective of the represents and warrants that: (i) He/she
Friday; it are also available challenge? is duly authorized to act on behalf of the
electronically at http:// To provide support to people in team or Organization; and (ii) each
www.regulations.gov. FDA has verified recovery from opioid use disorder member of the team (or in the case of
jstallworth on DSK7TPTVN1PROD with NOTICES
the Web site address, as of the date this receiving medication assisted-treatment Organization, each participating
document publishes in the Federal so that they can maintain treatment and member) has read the Official Rules and
Register, but Web sites are subject to achieve long-term recovery. agrees to abide by these Official Rules.
change over time. (4) What is the intended effect of this The Representative will ensure that
1. Meeting Materials of the Obstetrics action? each member of the team or
and Gynecology Devices Panel An increase in the number of Organization reads, agrees to, and
(2015), available at http:// individuals with opioid use disorders complies with the Official Rules.
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Document Created: 2018-02-02 15:05:20
Document Modified: 2018-02-02 15:05:20
| 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 | Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 3, 2016. | |
| 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 11577 |
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