82 FR 59623 - The Least Burdensome Provisions: Concept and Principles; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 240 (December 15, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 240 (December 15, 2017)
| Page Range | 59623-59625 | |
| FR Document | 2017-26987 |
[Federal Register Volume 82, Number 240 (Friday, December 15, 2017)] [Notices] [Pages 59623-59625] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-26987] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-6702] The Least Burdensome Provisions: Concept and Principles; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``The Least Burdensome Provisions: Concept and Principles'' FDA utilizes a least burdensome approach to medical device regulation to eliminate unnecessary burdens that may delay the marketing of beneficial new products, while maintaining the statutory requirements for clearance and approval. This document describes the guiding principles and recommended approach for FDA staff and industry to facilitate consistent application of least burdensome principles to the activities pertaining to products meeting the statutory definition of a device regulated under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This draft guidance is not final nor is it in effect at this time. DATES: Submit either electronic or written comments on the draft guidance by February 13, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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. 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-2017-D-6702 for ``The Least Burdensome Provisions: Concept and Principles; Draft Guidance for Industry and Food and Drug Administration Staff; Availability.'' 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 [[Page 59624]] 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 ``The Least Burdensome Provisions: Concept and Principles'' 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 to 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 Silverstein, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 66, Rm. 1615, Silver Spring, MD 20993-0002, 301- 796-5155; and 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 The FD&C Act, as amended by the FDA Modernization Act of 1997, the FDA Safety and Innovation Act (FDASIA), and the 21st Century Cures Act (Cures Act), includes least burdensome provisions that direct the Food and Drug Administration (FDA or Agency) to take a least burdensome approach to medical device evaluation in a manner that eliminates unnecessary burdens that may delay the marketing of beneficial new products, while maintaining the statutory requirements for clearance and approval. The updates to the least burdensome provisions in FDASIA and the Cures Act clarified the original least burdensome provisions and further recognized the role of postmarket activities as they relate to premarket decisions. FDA believes, as a matter of policy, that least burdensome principles should be consistently and widely applied to all activities in the premarket and postmarket settings to remove or reduce unnecessary burdens so that patients can have earlier and continued access to high quality, safe, and effective devices. This draft guidance, therefore, reflects FDA's belief that least burdensome principles should be applied throughout the medical device total product lifecycle. For the purposes of this guidance, FDA defines ``least burdensome'' as the minimum amount of information necessary to adequately address a regulatory question or issue through the most efficient manner at the right time. This draft guidance describes the least burdensome guiding principles and recommended approach for FDA staff and industry to ensure consistent application of least burdensome principles to the activities pertaining to products meeting the statutory definition of a device regulated under the FD&C Act. This guidance document, when finalized, will replace the 2002 Least Burdensome Guidance entitled ``The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles'' (October 4, 2002). 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 Least Burdensome Provisions: Concept and Principles.'' 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 downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This guidance document is also available at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or https://www.regulations.gov. Persons unable to download an electronic copy of ``The Least Burdensome Provisions: Concept and Principles; Draft Guidance for Industry and Food and Drug Administration Staff'' may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1332 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information. 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 the following FDA regulations, guidance, and forms have been approved by OMB as listed in the following table: ------------------------------------------------------------------------ OMB control 21 CFR part; guidance; or FDA form Topic No. ------------------------------------------------------------------------ 820............................... Quality system 0910-0073 regulation. 812............................... Investigational 0910-0078 device exemption. 807, subpart E.................... Premarket 0910-0120 notification. 860.123........................... Reclassification 0910-0138 petition. 814, subparts A through E......... Premarket approval.. 0910-0231 814, subpart H.................... Humanitarian device 0910-0332 exemption. 803............................... Medical device 0910-0437 reporting. 822............................... Postmarket 0910-0449 surveillance. Form FDA 3670..................... Adverse event 0910-0471 reports/MedSun program. [[Page 59625]] 801 and 809....................... Labeling............ 0910-0485 ``Recommendations: Clinical CLIA waiver......... 0910-0598 Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices''. 807, subparts A through D......... Registration and 0910-0625 listing. ``Requests for Feedback on Medical Q-submissions....... 0910-0756 Device Submissions: The Pre- Submission Program and Meetings with Food and Drug Administration Staff''. ``De Novo Classification Process De Novo 0910-0844 (Evaluation of Automatic Class classification III Designation)''. process. ------------------------------------------------------------------------ Dated: December 11, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-26987 Filed 12-14-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 240 / Friday, December 15, 2017 / Notices 59623
the sponsor of a rare pediatric disease DEPARTMENT OF HEALTH AND comments, that information will be
product application. The Federal Food, HUMAN SERVICES posted on https://www.regulations.gov.
Drug, and Cosmetic Act (the FD&C Act), • If you want to submit a comment
as amended by the Food and Drug Food and Drug Administration with confidential information that you
Administration Safety and Innovation [Docket No. FDA–2017–D–6702]
do not wish to be made available to the
Act (FDASIA), authorizes FDA to award public, submit the comment as a
priority review vouchers to sponsors of The Least Burdensome Provisions: written/paper submission and in the
approved rare pediatric disease product Concept and Principles; Draft manner detailed (see ‘‘Written/Paper
Guidance for Industry and Food and Submissions’’ and ‘‘Instructions’’).
applications that meet certain criteria.
FDA is required to publish notice of the Drug Administration Staff; Availability Written/Paper Submissions
award of the priority review voucher. AGENCY: Food and Drug Administration, Submit written/paper submissions as
FDA has determined that MEPSEVII HHS. follows:
(vestronidase alfa-vjbk), manufactured ACTION: Notice of availability. • Mail/Hand delivery/Courier (for
by Ultragenyx Pharmaceutical, Inc., written/paper submissions): Dockets
meets the criteria for a priority review SUMMARY: The Food and Drug Management Staff (HFA–305), Food and
voucher. Administration (FDA or Agency) is Drug Administration, 5630 Fishers
announcing the availability of the draft Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: guidance entitled ‘‘The Least • For written/paper comments
Althea Cuff, Center for Drug Evaluation Burdensome Provisions: Concept and submitted to the Dockets Management
and Research, Food and Drug Principles’’ FDA utilizes a least Staff, FDA will post your comment, as
Administration, 10903 New Hampshire burdensome approach to medical device well as any attachments, except for
Ave., Silver Spring, MD 20993–0002, regulation to eliminate unnecessary information submitted, marked and
301–796–4061, Fax: 301–796–9856, burdens that may delay the marketing of identified, as confidential, if submitted
email: althea.cuff@fda.hhs.gov. beneficial new products, while as detailed in ‘‘Instructions.’’
maintaining the statutory requirements Instructions: All submissions received
SUPPLEMENTARY INFORMATION: FDA is for clearance and approval. This must include the Docket No. FDA–
announcing the issuance of a priority document describes the guiding 2017–D–6702 for ‘‘The Least
review voucher to the sponsor of an principles and recommended approach Burdensome Provisions: Concept and
approved rare pediatric disease product for FDA staff and industry to facilitate Principles; Draft Guidance for Industry
application. Under section 529 of the consistent application of least and Food and Drug Administration
FD&C Act (21 U.S.C. 360ff), which was burdensome principles to the activities Staff; Availability.’’ Received comments
added by FDASIA, FDA will award pertaining to products meeting the will be placed in the docket and, except
priority review vouchers to sponsors of statutory definition of a device regulated for those submitted as ‘‘Confidential
approved rare pediatric disease product under the Federal Food, Drug, and Submissions,’’ publicly viewable at
applications that meet certain criteria. Cosmetic Act (the FD&C Act). This draft https://www.regulations.gov or at the
FDA has determined that MEPSEVII guidance is not final nor is it in effect Dockets Management Staff between 9
(vestronidase alfa-vjbk), manufactured at this time. a.m. and 4 p.m., Monday through
by Ultragenyx Pharmaceutical, Inc., DATES: Submit either electronic or Friday.
meets the criteria for a priority review written comments on the draft guidance • Confidential Submissions—To
voucher. MEPSEVII (vestronidase alfa- by February 13, 2018 to ensure that the submit a comment with confidential
vjbk) is indicated for the treatment of Agency considers your comment on this information that you do not wish to be
Mucopolysaccharidosis type VII (MPS draft guidance before it begins work on made publicly available, submit your
VII, Sly Syndrome). the final version of the guidance. comments only as a written/paper
ADDRESSES: You may submit comments submission. You should submit two
For further information about the Rare copies total. One copy will include the
Pediatric Disease Priority Review on any guidance at any time as follows:
information you claim to be confidential
Voucher Program and for a link to the Electronic Submissions with a heading or cover note that states
full text of section 529 of the FD&C Act, Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
go to https://www.fda.gov/ForIndustry/ following way: CONFIDENTIAL INFORMATION.’’ The
DevelopingProductsforRareDiseases • Federal eRulemaking Portal: Agency will review this copy, including
Conditions/RarePediatricDiseasePriority https://www.regulations.gov. Follow the the claimed confidential information, in
VoucherProgram/default.htm. For instructions for submitting comments. its consideration of comments. The
further information about MEPSEVII Comments submitted electronically, second copy, which will have the
(vestronidase alfa-vjbk), go to the including attachments, to https:// claimed confidential information
‘‘Drugs@FDA’’ website at https://www. www.regulations.gov will be posted to redacted/blacked out, will be available
accessdata.fda.gov/scripts/cder/daf/. the docket unchanged. Because your for public viewing and posted on
comment will be made public, you are https://www.regulations.gov. Submit
Dated: December 12, 2017.
solely responsible for ensuring that your both copies to the Dockets Management
Leslie Kux, comment does not include any Staff. If you do not wish your name and
Associate Commissioner for Policy. confidential information that you or a contact information to be made publicly
third party may not wish to be posted, available, you can provide this
sradovich on DSK3GMQ082PROD with NOTICES
[FR Doc. 2017–27049 Filed 12–14–17; 8:45 am]
BILLING CODE 4164–01–P such as medical information, your or information on the cover sheet and not
anyone else’s Social Security number, or in the body of your comments and you
confidential business information, such must identify this information as
as a manufacturing process. Please note ‘‘confidential.’’ Any information marked
that if you include your name, contact as ‘‘confidential’’ will not be disclosed
information, or other information that except in accordance with 21 CFR 10.20
identifies you in the body of your and other applicable disclosure law. For
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OMB control
21 CFR part; guidance; or FDA form Topic No.
801 and 809 ......................................................................................................... Labeling ............................................................ 0910–0485
‘‘Recommendations: Clinical Laboratory Improvement Amendments of 1988 CLIA waiver ...................................................... 0910–0598
(CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices’’.
807, subparts A through D ................................................................................... Registration and listing ..................................... 0910–0625
‘‘Requests for Feedback on Medical Device Submissions: The Pre-Submission Q-submissions .................................................. 0910–0756
Program and Meetings with Food and Drug Administration Staff’’.
‘‘De Novo Classification Process (Evaluation of Automatic Class III Designa- De Novo classification process ........................ 0910–0844
tion)’’.
Dated: December 11, 2017. Information Collection Clearance enable HRSA to provide aggregate
Leslie Kux, Officer, Room 14N39, 5600 Fishers program data required by Congress
Associate Commissioner for Policy. Lane, Rockville, MD 20857. under the Government Performance and
[FR Doc. 2017–26987 Filed 12–14–17; 8:45 am] FOR FURTHER INFORMATION CONTACT: To Results Act (GPRA) of 1993. These
BILLING CODE 4164–01–P request more information on the measures cover the principal topic areas
proposed project or to obtain a copy of of interest to the Federal Office of Rural
the data collection plans and draft Health Policy (FORHP), including: (a)
DEPARTMENT OF HEALTH AND instruments, email paperwork@hrsa.gov Target population demographics; (b)
HUMAN SERVICES or call Lisa Wright-Solomon, the HRSA referrals to substance abuse treatment;
Information Collection Clearance Officer (c) substance abuse treatment process
Health Resources and Services at (301) 443–1984. and outcomes; (d) education of health
Administration care providers and community
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting members; and (e) rates of fatal and non-
Agency Information Collection fatal opioid-related overdose. All
Activities: Proposed Collection: Public information, please include the
information request collection title for measures will speak to FORHP’s
Comment Request; Information progress toward meeting the goals set.
Collection Request Title: Rural Health reference.
Information Collection Request Title: Likely Respondents: The respondents
Opioid Program Grant Performance would be recipients of the Rural Health
Measures, OMB No. 0906–xxxx–New Rural Health Opioid Program Grant
Performance Measures. Opioid Program grant funding.
AGENCY: Health Resources and Services OMB No. 0906–xxxx–New. Burden Statement: Burden in this
Administration (HRSA), Department of Abstract: The Rural Health Opioid context means the time expended by
Health and Human Services. Program aims to promote rural health persons to generate, maintain, retain,
ACTION: Notice care services outreach by expanding the disclose or provide the information
delivery of opioid related health care requested. This includes the time
SUMMARY: In compliance with the services to rural communities. The needed to review instructions; to
requirement for opportunity for public program will work to reduce the develop, acquire, install and utilize
comment on proposed data collection morbidity and mortality related to technology and systems for the purpose
projects of the Paperwork Reduction Act opioid overdoses in rural communities of collecting, validating and verifying
of 1995, HRSA announces plans to through the development of broad information, processing and
submit an Information Collection community consortiums to prepare maintaining information, and disclosing
Request (ICR), described below, to the individuals with opioid-use disorder to and providing information; to train
Office of Management and Budget start treatment, implement care personnel and to be able to respond to
(OMB). Prior to submitting the ICR to coordination practices to organize a collection of information; to search
OMB, HRSA seeks comments from the patient care activities, and support data sources; to complete and review
public regarding the burden estimate, individuals in recovery through the the collection of information; and to
below, or any other aspect of the ICR. enhancement of behavioral counselling transmit or otherwise disclose the
DATES: Comments on this ICR should be and peer support activities. information. The total annual burden
received no later than February 13, Need and Proposed Use of the hours estimated for this ICR are
2018. Information: For this program, summarized in the table below.
ADDRESSES: Submit your comments to performance measures were drafted to Total Estimated Annualized Burden
paperwork@hrsa.gov or mail the HRSA provide data to the program and to Hours:
Average
Number of
Number of Total burden per Total burden
Form name responses per
respondents responses response hours
respondent (in hours)
Rural Health Opioid Program Grant Performance Meas-
ures ................................................................................... 10 1 10 11 110
sradovich on DSK3GMQ082PROD with NOTICES
.............................................................................................. 10 ........................ 10 ........................ 110
HRSA specifically requests comments proper performance of the agency’s the quality, utility, and clarity of the
on: (1) The necessity and utility of the functions; (2) the accuracy of the information to be collected; and (4) the
proposed information collection for the estimated burden; (3) ways to enhance use of automated collection techniques
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Document Created: 2017-12-15 03:37:48
Document Modified: 2017-12-15 03:37:48
| 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 February 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 Silverstein, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 66, Rm. 1615, Silver Spring, MD 20993-0002, 301- 796-5155; and 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 | 82 FR 59623 |
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