83 FR 27614 - Humanitarian Device Exemption Program; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 114 (June 13, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 114 (June 13, 2018)
| Page Range | 27614-27616 | |
| FR Document | 2018-12633 |
[Federal Register Volume 83, Number 114 (Wednesday, June 13, 2018)] [Notices] [Pages 27614-27616] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-12633] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-D-0223] Humanitarian Device Exemption Program; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Humanitarian Device Exemption (HDE) Program.'' This draft guidance concerns the HDE program as a whole and, among other topics, it explains the criteria FDA considers to determine if ``probable benefit'' has been demonstrated as part of the Agency's decision-making process regarding marketing authorization for a humanitarian use device (HUD). The draft guidance also incorporates recent amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) that affect the HDE program and answers other common questions that we receive about the program. This draft guidance is not final nor is it in effect at this time. DATES: Submit either electronic or written comments on the draft guidance by August 13, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://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 https://www.regulations.gov. [[Page 27615]] 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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, 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-2014-D-0223 for ``Humanitarian Device Exemption (HDE) Program.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). 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 draft guidance document entitled ``Humanitarian Device Exemption (HDE) Program'' 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 or the Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request. FOR FURTHER INFORMATION CONTACT: Joshua Nipper, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002, 301-796-6524; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. SUPPLEMENTARY INFORMATION: I. Background FDA developed this draft guidance to clarify to industry and FDA staff the current review practices for the HDE program. This draft guidance answers common questions about the HDE program and responds to a requirement in the 21st Century Cures Act (Cures Act, Pub. L. 114- 255) to define the criteria for establishing ``probable benefit'' as that term is used in section 520(m)(2)(C) of the FD&C Act (21 U.S.C. 360j(m)(2)(C)). This draft guidance incorporates recent amendments to the FD&C Act that affect the HDE program. Specifically, section 3052 of the Cures Act modified the eligibility for an HDE by increasing the threshold number of patients affected by the disease or condition that a HUD is designed to treat or diagnose to ``not more than 8,000 individuals in the United States.'' Further, section 3056 the Cures Act removed the requirement that institutional review committees, i.e., institutional review boards (IRBs), that supervise the clinical testing of HUDs or approve the use of HUDs in clinical care be local. Additionally, the FDA Reauthorization Act of 2017 (Pub. L. 115-52) amended section 520(m) of the FD&C Act to provide that the use of a device under an HDE at a facility to treat or diagnose patients may be approved by an IRB or an appropriate local committee. Previously, section 520(m)(4) of the FD&C Act only allowed an IRB to perform this function. FDA is providing an interpretation of the term ``appropriate local committee'' in this draft guidance, and we welcome comment on the characteristics that should define an appropriate local committee for purposes of the HDE program. This draft guidance supplants the draft guidance, ``Humanitarian Device Exemption (HDE): Questions and Answers--Draft Guidance for HDE Holders, IRBs, Clinical Investigators, and Food and Drug Administration Staff,'' issued on March 18, 2014. When final, this guidance will supersede the guidance, ``Guidance for HDE holders, IRBs, Clinical Investigators, and Food and Drug Administration Staff, HDE Regulation: Questions and Answers,'' issued on July 8, 2010, available online at: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM110203. 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 the Humanitarian Device Exemption Program. 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. This guidance is not subject to Executive Order 12866. III. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by [[Page 27616]] 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. This guidance document is also available at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or https://www.regulations.gov. Persons unable to download an electronic copy of ``Humanitarian Device Exemption (HDE) Program'' may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 17040 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 and guidance. 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 10 have been approved under OMB control number 0910-0191; the collections of information in 21 CFR parts 50 and 56 have been approved under OMB control numbers 0910-0755 and 0910-0130; the collections of information in 21 CFR part 54 have been approved under OMB control number 0910- 0396; the collections of information in 21 CFR part 803 have been approved under OMB control number 0910-0437; 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 part 814, subparts A through E, have been approved under OMB control number 0910- 0231; the collections of information in 21 CFR part 814, subpart H, have been approved under OMB control number 0910-0332; the collections of information in 21 CFR part 820 have been approved under OMB control number 0910-0073; the collections of information regarding Information to Accompany HDE Applications and Annual Distribution Number Reporting Requirements have been approved under OMB control number 0910-0661; and the collections of information in the guidance document ``De Novo Classification Process (Evaluation of Automatic Class III Designation)'' have been approved under OMB control number 0910-0844. Dated: June 7, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-12633 Filed 6-12-18; 8:45 am] BILLING CODE 4164-01-P
![27614 Federal Register / Vol. 83, No. 114 / Wednesday, June 13, 2018 / Notices
found in FDA regulations. These document publishes in the Federal DEPARTMENT OF HEALTH AND
collections of information are subject to Register, but websites are subject to HUMAN SERVICES
review by the Office of Management and change over time.
Budget (OMB) under the Paperwork Food and Drug Administration
1. ‘‘Guidance for Industry and FDA Staff:
Reduction Act of 1995 (44 U.S.C. 3501– Current Good Manufacturing Practice
3520). We note that the information [Docket No. FDA–2014–D–0223]
Requirements for Combination
collected under the underlying CGMP Products,’’ January 2017. https:// Humanitarian Device Exemption
regulations for drugs, devices, and www.fda.gov/RegulatoryInformation/ Program; Draft Guidance for Industry
biological products, including current Guidances/ucm126198.htm. and Food and Drug Administration
good tissue practices for HCT/Ps, found 2. ‘‘Guidance for Industry: Q1D Bracketing Staff; Availability
in parts 211, 820, 600 through 680, and and Matrixing Designs for Stability
1271, have already been approved and Testing of New Drug Substances and AGENCY: Food and Drug Administration,
are in effect. The provisions of part 211 Products,’’ January 2003. https://www. HHS.
are approved under the OMB control fda.gov/downloads/Drugs/Guidances/ ACTION: Notice of availability.
number 0910–0139. The provisions of ucm073379.pdf.
part 820 are approved under OMB 3. ‘‘Draft Guidance for Industry: Formal SUMMARY: The Food and Drug
control number 0910–0073. The Meetings Between the FDA and Sponsors Administration (FDA or Agency) is
provisions of parts 606 and 640 are or Applicants of PDUFA Products,’’ announcing the availability of the draft
approved under OMB control number December 2017. https://www.fda.gov/ guidance entitled ‘‘Humanitarian Device
0910–0116. The provisions of part 610 downloads/Drugs/GuidanceCompliance Exemption (HDE) Program.’’ This draft
are approved under OMB control RegulatoryInformation/Guidances/ guidance concerns the HDE program as
number 0910–0116 and OMB control UCM590547.pdf. a whole and, among other topics, it
number 0910–0338 (also for part 680). 4. ‘‘Draft Guidance for Industry: Formal explains the criteria FDA considers to
The provisions of part 1271, subparts C Meetings Between FDA and ANDA determine if ‘‘probable benefit’’ has
and D, are approved under OMB control Applicants of Complex Products Under been demonstrated as part of the
number 0910–0543. GDUFA,’’ October 2017. https://
Agency’s decision-making process
We note that the information www.fda.gov/downloads/drugs/guidance
regarding marketing authorization for a
collected under the related submission complianceregulatoryinformation/
humanitarian use device (HUD). The
types have already been approved and guidances/ucm578366.pdf.
5. ‘‘Guidance for Industry and Food and Drug
draft guidance also incorporates recent
are in effect. The collections of amendments to the Federal Food, Drug,
information regarding formal meetings Administration Staff: Requests for
Feedback on Medical Device and Cosmetic Act (FD&C Act) that affect
with sponsors and applicants have been the HDE program and answers other
Submissions: The Pre-Submission
approved under OMB control number common questions that we receive
Program and Meetings with Food and
0910–0429. The collections of about the program. This draft guidance
Drug Administration Staff,’’ September
information regarding new drug is not final nor is it in effect at this time.
2017. https://www.fda.gov/downloads/
approvals (NDA) and abbreviated new
medicaldevices/deviceregulationand DATES: Submit either electronic or
drug applications (ANDA) have been guidance/guidancedocuments/ written comments on the draft guidance
approved under OMB control number ucm311176.pdf. by August 13, 2018 to ensure that the
0910–0001. The collections of 6. ‘‘eCTD Technical Conformance Guide,’’
information regarding pre-ANDAs have Agency considers your comment on this
November 2017. https://www.fda.gov/ draft guidance before it begins work on
been approved under OMB control downloads/Drugs/UCM465411.pdf.
number 0910–0797. The collections of the final version of the guidance.
7. ‘‘Guidance for Industry: Changes to an
information regarding pre-submissions ADDRESSES: You may submit comments
Approved NDA or ANDA,’’ April 2004.
have been approved under OMB control https://www.fda.gov/downloads/drugs/
on any guidance at any time as follows:
number 0910–0756. The collections of guidancecomplianceregulatory Electronic Submissions
information regarding PMAs have been information/guidances/ucm077097.pdf.
approved under OMB control number 8. ‘‘Draft Guidance for Industry: Chemistry, Submit electronic comments in the
0910–0231. The collections of Manufacturing, and Controls Changes to following way:
information for premarket notification an Approved Application: Certain • Federal eRulemaking Portal:
(510(k)) have been approved under Biological Products,’’ December 2017. https://www.regulations.gov. Follow the
OMB control number 0910–0120. The https://www.fda.gov/downloads/ instructions for submitting comments.
collections of information for the de BiologicsBloodVaccines/Guidance Comments submitted electronically,
novo classification process have been ComplianceRegulatoryInformation/ including attachments, to https://
approved under OMB control number Guidances/General/UCM590118.pdf. www.regulations.gov will be posted to
0910–0844. The collections of 9. ‘‘Guidance for Industry and FDA Staff: 30- the docket unchanged. Because your
information regarding biologics license Day Notices, 135-Day Premarket comment will be made public, you are
applications have been approved under Approval (PMA) Supplements and 75- solely responsible for ensuring that your
OMB control number 0910–0338. Day Humanitarian Device Exemption comment does not include any
(HDE) Supplements for Manufacturing confidential information that you or a
VI. References Method or Process Changes,’’ April 2011. third party may not wish to be posted,
The following references are on https://www.fda.gov/downloads/Medical such as medical information, your or
display in the Dockets Management Devices/DeviceRegulationandGuidance/ anyone else’s Social Security number, or
amozie on DSK3GDR082PROD with NOTICES1
Staff (see ADDRESSES) and are available GuidanceDocuments/UCM080194.pdf. confidential business information, such
for viewing by interested persons Dated: June 7, 2018.
as a manufacturing process. Please note
between 9 a.m. and 4 p.m., Monday that if you include your name, contact
Leslie Kux,
through Friday; they are also available information, or other information that
electronically at https:// Associate Commissioner for Policy. identifies you in the body of your
www.regulations.gov. FDA has verified [FR Doc. 2018–12634 Filed 6–12–18; 8:45 am] comments, that information will be
the website addresses, as of the date this BILLING CODE 4164–01–P posted on https://www.regulations.gov.
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![27616 Federal Register / Vol. 83, No. 114 / Wednesday, June 13, 2018 / Notices
downloading an electronic copy from Dated: June 7, 2018. • If you want to submit a comment
the internet. A search capability for all Leslie Kux, with confidential information that you
Center for Devices and Radiological Associate Commissioner for Policy. do not wish to be made available to the
Health guidance documents is available [FR Doc. 2018–12633 Filed 6–12–18; 8:45 am] public, submit the comment as a
at http://www.fda.gov/MedicalDevices/ BILLING CODE 4164–01–P
written/paper submission and in the
DeviceRegulationandGuidance/ manner detailed (see ‘‘Written/Paper
GuidanceDocuments/default.htm. This Submissions’’ and ‘‘Instructions’’).
guidance document is also available at DEPARTMENT OF HEALTH AND Written/Paper Submissions
http://www.fda.gov/BiologicsBlood HUMAN SERVICES
Vaccines/GuidanceCompliance Submit written/paper submissions as
Food and Drug Administration follows:
RegulatoryInformation/default.htm or
• Mail/Hand delivery/Courier (for
https://www.regulations.gov. Persons [Docket No. FDA–2018–D–2032] written/paper submissions): Dockets
unable to download an electronic copy Management Staff (HFA–305), Food and
of ‘‘Humanitarian Device Exemption Limited Population Pathway for Drug Administration, 5630 Fishers
(HDE) Program’’ may send an email Antibacterial and Antifungal Drugs; Lane, Rm. 1061, Rockville, MD 20852.
request to CDRH-Guidance@fda.hhs.gov Draft Guidance for Industry; • For written/paper comments
to receive an electronic copy of the Availability submitted to the Dockets Management
document. Please use the document Staff, FDA will post your comment, as
number 17040 to identify the guidance AGENCY: Food and Drug Administration,
well as any attachments, except for
you are requesting. HHS.
information submitted, marked and
ACTION: Notice of availability. identified, as confidential, if submitted
IV. Paperwork Reduction Act of 1995
SUMMARY: The Food and Drug as detailed in ‘‘Instructions.’’
This draft guidance refers to Instructions: All submissions received
Administration (FDA or Agency) is
previously approved collections of must include the Docket No. FDA–
announcing the availability of a draft
information found in FDA regulations 2018–D–2032 for ‘‘Limited Population
guidance for industry entitled ‘‘Limited
and guidance. These collections of Pathway for Antibacterial and
Population Pathway for Antibacterial Antifungal Drugs; Draft Guidance for
information are subject to review by the and Antifungal Drugs.’’ This guidance
Office of Management and Budget Industry; Availability.’’ Received
provides information on the comments will be placed in the docket
(OMB) under the Paperwork Reduction implementation of the limited and, except for those submitted as
Act of 1995 (44 U.S.C. 3501–3520). The population pathway provision of the ‘‘Confidential Submissions,’’ publicly
collections of information in 21 CFR 21st Century Cures Act (Cures Act), viewable at https://www.regulations.gov
part 10 have been approved under OMB which established the limited or at the Dockets Management Staff
control number 0910–0191; the population pathway for antibacterial between 9 a.m. and 4 p.m., Monday
collections of information in 21 CFR and antifungal drugs (LPAD pathway). through Friday.
parts 50 and 56 have been approved DATES: Submit either electronic or • Confidential Submissions—To
under OMB control numbers 0910–0755 written comments on the draft guidance submit a comment with confidential
and 0910–0130; the collections of by August 13, 2018 to ensure that the information that you do not wish to be
information in 21 CFR part 54 have been Agency considers your comment on this made publicly available, submit your
approved under OMB control number draft guidance before it begins work on comments only as a written/paper
0910–0396; the collections of the final version of the guidance. submission. You should submit two
information in 21 CFR part 803 have ADDRESSES: You may submit comments copies total. One copy will include the
been approved under OMB control on any guidance at any time as follows: information you claim to be confidential
number 0910–0437; the collections of with a heading or cover note that states
information in 21 CFR part 812 have Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
been approved under OMB control Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
number 0910–0078; the collections of following way: Agency will review this copy, including
information in 21 CFR part 814, • Federal eRulemaking Portal: the claimed confidential information, in
subparts A through E, have been https://www.regulations.gov. Follow the its consideration of comments. The
approved under OMB control number instructions for submitting comments. second copy, which will have the
0910–0231; the collections of Comments submitted electronically, claimed confidential information
information in 21 CFR part 814, subpart including attachments, to https:// redacted/blacked out, will be available
H, have been approved under OMB www.regulations.gov will be posted to for public viewing and posted on
control number 0910–0332; the the docket unchanged. Because your https://www.regulations.gov. Submit
collections of information in 21 CFR comment will be made public, you are both copies to the Dockets Management
part 820 have been approved under solely responsible for ensuring that your Staff. If you do not wish your name and
OMB control number 0910–0073; the comment does not include any contact information to be made publicly
collections of information regarding confidential information that you or a available, you can provide this
Information to Accompany HDE third party may not wish to be posted, information on the cover sheet and not
Applications and Annual Distribution such as medical information, your or in the body of your comments and you
Number Reporting Requirements have anyone else’s Social Security number, or must identify this information as
amozie on DSK3GDR082PROD with NOTICES1
been approved under OMB control confidential business information, such ‘‘confidential.’’ Any information marked
number 0910–0661; and the collections as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed
of information in the guidance that if you include your name, contact except in accordance with 21 CFR 10.20
document ‘‘De Novo Classification information, or other information that and other applicable disclosure law. For
Process (Evaluation of Automatic Class identifies you in the body of your more information about FDA’s posting
III Designation)’’ have been approved comments, that information will be of comments to public dockets, see 80
under OMB control number 0910–0844. posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access
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Document Created: 2018-06-12 23:58:55
Document Modified: 2018-06-12 23:58:55
| 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 the draft guidance by August 13, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Joshua Nipper, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002, 301-796-6524; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. | |
| FR Citation | 83 FR 27614 |
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