81 FR 78167 - Clinical Considerations for Investigational Device Exemptions for Neurological Devices Targeting Disease Progression and Clinical Outcomes; 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 215 (November 7, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 215 (November 7, 2016)
| Page Range | 78167-78169 | |
| FR Document | 2016-26783 |
[Federal Register Volume 81, Number 215 (Monday, November 7, 2016)] [Notices] [Pages 78167-78169] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-26783] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-0539] Clinical Considerations for Investigational Device Exemptions for Neurological Devices Targeting Disease Progression and Clinical Outcomes; 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 [[Page 78168]] guidance entitled ``Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes.'' The Center for Devices and Radiological Health (CDRH) developed this guidance to assist sponsors who intend to submit an IDE to FDA to conduct clinical trials on medical devices targeting neurological disease progression and clinically meaningful patient centered outcomes. FDA considered comments received on the draft guidance and revised the guidance as appropriate. 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-0539 for ``Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes.'' 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. 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 ``Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes'' 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: Carlos Pe[ntilde]a, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2680, Silver Spring, MD 20993-0002, 301- 796-6610. SUPPLEMENTARY INFORMATION: I. Background FDA believes that neurological devices intended to slow disease progression and improve clinical outcomes that are meaningful may represent a revolutionary option for patients. FDA developed this guidance to assist sponsors who intend to submit an IDE to FDA to conduct clinical trials on medical devices targeting neurological disease progression and clinically meaningful patient-centered outcomes. The guidance is intended to aid industry and FDA staff in considering the benefits and risks of medical devices that target either the cause or progression of the neurological disorder or condition such as Alzheimer's disease, Parkinson's disease, or Primary Dystonia, rather than their symptoms. It is intended to apply to neurological medical devices that are designed to slow, stop, or reverse the progression of disease and result in clinically meaningful patient outcomes. This guidance provides general study design considerations for clinical trials that investigate neurological devices using biological markers and clinical outcome assessments. A draft guidance regarding general study design considerations for clinical trials that investigate neurological devices using biomarkers and clinical outcome assessments was announced in the Federal Register on March 7, 2016 (81 FR 11807) and made available for public comment. The comment period closed on June 6, 2016. FDA reviewed and considered all public comments received and revised the guidance as appropriate. [[Page 78169]] 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 ``Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes.'' 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 ``Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes'' may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1500021 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 812 have been approved under OMB control number 0910-0078; the collections of information in 21 CFR parts 801 and 809 have been approved under OMB control number 0910- 0485; the collections of information in 21 CFR part 50 have been approved under OMB control number 0910-0755; and the collections of information in the guidance document entitled ``Request for Feedback on Medical Device Submissions: The Pre-submission Program and Meetings With Food and Drug Administration Staff'' have been approved under OMB control number 0910-0756. Dated: November 1, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-26783 Filed 11-4-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 215 / Monday, November 7, 2016 / Notices 78167
Section 3506(c)(2)(A) of the PRA (44 Potential Tobacco Product Violations cigarette, smokeless, roll-your-own,
U.S.C. 3506(c)(2)(A)) requires Federal Reporting Form—OMB Control Number cigar, e-cigarette, hookah, pipe tobacco);
Agencies to provide a 60-day notice in 0910–0716—Extension tobacco brand; potential violation type;
the Federal Register concerning each On June 22, 2009, the President type of potentially violative promotional
proposed collection of information, signed the Family Smoking Prevention materials; who potentially violated; and
including each proposed extension of an and Tobacco Control Act (the Tobacco the name, address, phone number, and
existing collection of information, Control Act) (Pub. L. 111–31) into law. email address of the potential violator.
before submitting the collection to OMB The Tobacco Control Act amended The caller will also be asked to list the
for approval. To comply with this section 201 et seq. of the Federal Food, potential violator’s Web site (if
requirement, FDA is publishing notice Drug, and Cosmetic Act (the FD&C Act) available), describe the potential
of the proposed collection of (21 U.S.C. 321 et seq.) by adding a new violation, and provide any additional
information set forth in this document. chapter granting FDA important new files or information pertinent to the
authority to regulate the manufacture, potential violation.
With respect to the following marketing, and distribution of tobacco FDA currently provides a form that
collection of information, FDA invites products to protect the public health may be used to solicit this information
comments on these topics: (1) Whether generally and to reduce tobacco use by from the caller (Form FDA 3779,
the proposed collection of information minors. FDA is requesting an extension Potential Tobacco Product Violations
is necessary for the proper performance of OMB approval for the collection of Report), and seeks renewal of Form FDA
of FDA’s functions, including whether information to accept consumer and 3779. This form is posted on FDA’s Web
the information will have practical other stakeholder feedback and site. The public and interested
utility; (2) the accuracy of FDA’s notification of potential violations of the stakeholders are also able to report
estimate of the burden of the proposed FD&C Act, as amended by the Tobacco information regarding possible
collection of information, including the Control Act. violations of the Tobacco Control Act
validity of the methodology and FDA created a Tobacco Call Center through the following methods: Calling
assumptions used; (3) ways to enhance (with a toll-free number: 1–877–CTP– the Tobacco Call Center using the
the quality, utility, and clarity of the 1373). Callers are able to report Center for Tobacco Products’ (CTP) toll-
information to be collected; and (4) potential violations of the Tobacco free number; using a fillable Form FDA
ways to minimize the burden of the Control Act, and FDA may conduct 3779 found on FDA’s Web site;
collection of information on followup investigations based on downloading a PDF version of the form
respondents, including through the use information received. When callers to send via email or mail to FDA;
of automated collection techniques, report a violation, the caller will be requesting a copy of Form FDA 3779 by
asked to provide as much certain contacting CTP and sending by mail to
when appropriate, and other forms of
information as they can recall, FDA; and sending a letter to FDA’s CTP.
information technology.
including: The date the potential FDA estimates the burden of this
violation occurred; product type (e.g., collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden per
Activity and FDA form 3779 responses per Total hours
respondents responses response
respondent
Reporting violations of the FD&C Act, as amended 750 2 1,500 0.25 (15 minutes) ...... 375
by the Tobacco Control Act via telephone, Inter-
net form, mail, smartphone application, or email.
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA estimates that submitting the complete and submit; therefore, total DEPARTMENT OF HEALTH AND
information (by telephone, Internet burden hours for this collection of HUMAN SERVICES
form, paper form by mail, or email) will information is estimated to be 375 hours
take 0.25 hour (i.e., 15 minutes) per (1,500 responses × 0.25 hour per Food and Drug Administration
response. Based on the type and rate of response).
reporting that has been submitted [Docket No. FDA–2016–D–0539]
Dated: October 27, 2016.
through the Potential Tobacco Violation
Leslie Kux, Clinical Considerations for
Reporting Form in the past, in addition
Associate Commissioner for Policy. Investigational Device Exemptions for
to the increase that FDA has recently
Neurological Devices Targeting
experienced in the rate of reporting due [FR Doc. 2016–26758 Filed 11–4–16; 8:45 am]
Disease Progression and Clinical
to the recent rule, ‘‘Deeming Tobacco BILLING CODE 4164–01–P
Outcomes; Guidance for Industry and
Products To Be Subject to the Federal
Food and Drug Administration Staff;
Food, Drug, and Cosmetic Act, as
Availability
Amended by the Family Smoking
sradovich on DSK3GMQ082PROD with NOTICES
Prevention and Tobacco Control Act,’’ AGENCY: Food and Drug Administration,
FDA estimates the number of annual HHS.
respondents to this collection of ACTION: Notice of availability.
information will be 750, who will each
submit 2 reports by telephone, Internet SUMMARY: The Food and Drug
form, paper form, or email. Each report Administration (FDA or Agency) is
is expected to take 0.25 hour to announcing the availability of the
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![Federal Register / Vol. 81, No. 215 / Monday, November 7, 2016 / Notices 78169
II. Significance of Guidance Dated: November 1, 2016. that if you include your name, contact
Leslie Kux, information, or other information that
This guidance is being issued Associate Commissioner for Policy. identifies you in the body of your
consistent with FDA’s good guidance [FR Doc. 2016–26783 Filed 11–4–16; 8:45 am] comments, that information will be
practices regulation (21 CFR 10.115). posted on http://www.regulations.gov.
BILLING CODE 4164–01–P
The guidance represents the current • If you want to submit a comment
thinking of FDA on ‘‘Clinical with confidential information that you
Considerations for Investigational DEPARTMENT OF HEALTH AND do not wish to be made available to the
Device Exemptions (IDEs) for HUMAN SERVICES public, submit the comment as a
Neurological Devices Targeting Disease written/paper submission and in the
Progression and Clinical Outcomes.’’ It Food and Drug Administration manner detailed (see ‘‘Written/Paper
does not establish any rights for any [Docket No. FDA–2016–N–3462]
Submissions’’ and ‘‘Instructions’’).
person and is not binding on FDA or the Written/Paper Submissions
public. You can use an alternative Establishment of the Patient and Care-
approach if it satisfies the requirements Partner Connection; Establishment of Submit written/paper submissions as
of the applicable statutes and a Public Docket; Request for follows:
• Mail/Hand delivery/Courier (for
regulations. Comments
written/paper submissions): Division of
III. Electronic Access AGENCY: Food and Drug Administration, Dockets Management (HFA–305), Food
HHS. and Drug Administration, 5630 Fishers
Persons interested in obtaining a copy ACTION: Notice; establishment of docket; Lane, Rm. 1061, Rockville, MD 20852.
of the guidance may do so by request for comments. • For written/paper comments
downloading an electronic copy from submitted to the Division of Dockets
the Internet. A search capability for all SUMMARY: The Food and Drug Management, FDA will post your
Center for Devices and Radiological Administration (FDA or Agency) is comment, as well as any attachments,
Health guidance documents is available establishing a public docket to receive except for information submitted,
at http://www.fda.gov/MedicalDevices/ input on the Center for Devices and marked and identified, as confidential,
DeviceRegulationandGuidance/ Radiological Health’s (CDRH) new if submitted as detailed in
GuidanceDocuments/default.htm. program, entitled the Patient and Care- ‘‘Instructions.’’
Guidance documents are also available partner Connection (P&CC). P&CC will Instructions: All submissions received
at http://www.regulations.gov. Persons partner with patient organizations to must include the Docket No. FDA–
unable to download an electronic copy provide a means for CDRH staff to 2016–N–3462 for ‘‘Establishment of the
of ‘‘Clinical Considerations for formally engage with patients and care- Patient and Care-partner Connection;
Investigational Device Exemptions partners. The purpose of this Establishment of a Public Docket;
(IDEs) for Neurological Devices partnership is to gain perspective and Request for Comments.’’ Received
Targeting Disease Progression and feedback from patients, care-partners, comments will be placed in the docket
Clinical Outcomes’’ may send an email and patient organizations on particular and, except for those submitted as
request to CDRH-Guidance@fda.hhs.gov topics of interest, such as, the scope and ‘‘Confidential Submissions,’’ publicly
to receive an electronic copy of the nature of P&CC and how to partner with viewable at http://www.regulations.gov
document. Please use the document patient organizations. The Agency is or at the Division of Dockets
number 1500021 to identify the interested in facilitating staff Management between 9 a.m. and 4 p.m.,
guidance you are requesting. engagement with patients and care- Monday through Friday.
partners regarding specific disease states • Confidential Submissions—To
IV. Paperwork Reduction Act of 1995 and/or medical devices used for submit a comment with confidential
treatment, diagnosis, or assessment. information that you do not wish to be
This guidance refers to previously DATES: Submit either electronic or made publicly available, submit your
approved collections of information written comments by January 6, 2017. comments only as a written/paper
found in FDA regulations. These submission. You should submit two
ADDRESSES: You may submit comments
collections of information are subject to copies total. One copy will include the
as follows:
review by the Office of Management and information you claim to be confidential
Budget (OMB) under the Paperwork Electronic Submissions with a heading or cover note that states
Reduction Act of 1995 (44 U.S.C. 3501– Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
3520). The collections of information in following way: CONFIDENTIAL INFORMATION.’’ The
21 CFR part 812 have been approved • Federal eRulemaking Portal: http:// Agency will review this copy, including
under OMB control number 0910–0078; www.regulations.gov. Follow the the claimed confidential information, in
the collections of information in 21 CFR instructions for submitting comments. its consideration of comments. The
parts 801 and 809 have been approved Comments submitted electronically, second copy, which will have the
under OMB control number 0910–0485; including attachments, to http:// claimed confidential information
the collections of information in 21 CFR www.regulations.gov will be posted to redacted/blacked out, will be available
part 50 have been approved under OMB the docket unchanged. Because your for public viewing and posted on http://
control number 0910–0755; and the comment will be made public, you are www.regulations.gov. Submit both
collections of information in the solely responsible for ensuring that your copies to the Division of Dockets
sradovich on DSK3GMQ082PROD with NOTICES
guidance document entitled ‘‘Request comment does not include any Management. If you do not wish your
for Feedback on Medical Device confidential information that you or a name and contact information to be
Submissions: The Pre-submission third party may not wish to be posted, made publicly available, you can
Program and Meetings With Food and such as medical information, your or provide this information on the cover
Drug Administration Staff’’ have been anyone else’s Social Security number, or sheet and not in the body of your
approved under OMB control number confidential business information, such comments and you must identify this
0910–0756. as a manufacturing process. Please note information as ‘‘confidential.’’ Any
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Document Created: 2018-02-14 08:21:55
Document Modified: 2018-02-14 08:21:55
| 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 | Carlos Pe[ntilde]a, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2680, Silver Spring, MD 20993-0002, 301- 796-6610. | |
| FR Citation | 81 FR 78167 |
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