83 FR 39105 - [Docket No. FDA-2011-N-0776] HEADAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reclassification Petitions for Medical Devices

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 153 (August 8, 2018)

Page Range		39105-39106
FR Document		2018-16983

The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Federal Register, Volume 83 Issue 153 (Wednesday, August 8, 2018)

[Federal Register Volume 83, Number 153 (Wednesday, August 8, 2018)]
[Notices]
[Pages 39105-39106]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-16983]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


[Docket No. FDA-2011-N-0776]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Reclassification 
Petitions for Medical Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that a proposed collection of information has been submitted to the 
Office of Management and Budget (OMB) for review and clearance under 
the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
September 7, 2018.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0138. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Reclassification Petitions for Medical Devices

OMB Control Number 0910-0138--Extension

    Under sections 513(e) and (f), 514(b), 515(b), and 520(l) of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360c(e) and 
(f), 360d(b), 360e(b), and 360j(l)) and part 860 (21 CFR part 860), 
subpart C, FDA has the responsibility to collect data and information 
contained in reclassification petitions. The reclassification 
provisions of the FD&C Act allow any person to petition for 
reclassification of a device from any of the three classes, i.e., I, 
II, and III, to another class. The reclassification content regulation 
(Sec.  860.123) requires the submission of valid scientific evidence 
demonstrating that the proposed reclassification will provide a 
reasonable assurance of safety and effectiveness of the device type for 
its indications for use.
    The reclassification procedure regulation requires the submission 
of specific data when a manufacturer is petitioning for 
reclassification. This includes a ``Supplemental Data Sheet,'' Form FDA 
3427, and a ``General Device Classification Questionnaire,'' Form FDA 
3429. Both forms contain a series of questions concerning the safety 
and effectiveness of the device type.
    In the Federal Register of March 25, 2014 (79 FR 16252), FDA issued 
a proposed rule that would eliminate the need for Forms FDA 3427 and 
3429. However, because the proposed rule has not been finalized, we 
continue to include the forms in the burden estimate for this 
information collection.
    The reclassification provisions of the FD&C Act serve primarily as 
a vehicle for manufacturers to seek reclassification from a higher to a 
lower class, thereby reducing the regulatory requirements applicable to 
a particular device type, or to seek reclassification from a lower to a 
higher class, thereby increasing the regulatory requirements applicable 
to that device type. If approved, petitions requesting classification 
from class III to class II or class I provide an alternative route to 
market in lieu of premarket approval for class III devices. If 
approved, petitions requesting reclassification from class I or II, to 
a different class, may increase requirements.
    In the Federal Register of March 07, 2018 (83 FR 9743), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one comment.
    The comment supports continued use of Forms FDA 3427 and FDA 3429. 
Specifically, the commenter is addressing the issue of discontinuing 
the forms as previously referenced, wherein FDA issued a proposed rule 
(79 FR 16252) to eliminate the need for the forms. Because FDA is not 
discontinuing use of the forms at this time, and this comment relates 
to the proposed rule (79 FR 16252) and not to the information 
collection itself, we make no changes to this information collection 
based on the comment.
    The Center for Devices and Radiological Health (CDRH) has 
continually maintained contact with industry. Informal communications 
concerning the importance and effect of reclassification are provided 
primarily through trade organizations, and via CDRH's website (https://www.fda.gov/MedicalDevices/default.htm).
    FDA estimates the burden of this collection of information as 
follows:

[[Page 39106]]



                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                            Number  of                        Average
                 Activity/21 CFR section                   FDA  form No.     Number of     responses per   Total  annual    burden per     Total  hours
                                                                            respondents     respondent       responses       response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Supporting data for reclassification petition--21 CFR     ..............               6               1               6             497           2,982
 860.123................................................
Supplemental Data Sheet.................................            3427               6               1               6             1.5               9
General Device Classification Questionnaire.............            3429               6               1               6             1.5               9
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............  ..............           3,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on reclassification petitions received in the past 3 years, 
FDA anticipates that six petitions will be submitted each year. The 
time required to prepare and submit a reclassification petition, 
including the time needed to assemble supporting data, averages 500 
hours per petition. This average is based upon estimates by FDA 
administrative and technical staff who: (1) Are familiar with the 
requirements for submission of a reclassification petition, (2) have 
consulted and advised manufacturers on these requirements, and (3) have 
reviewed the documentation submitted.
    The burden estimate for this information collection has not changed 
since the past OMB approval.

    Dated: August 2, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16983 Filed 8-7-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Notices 39105

You can use an alternative approach if of information has been submitted to the includes a ‘‘Supplemental Data Sheet,’’
it satisfies the requirements of the Office of Management and Budget Form FDA 3427, and a ‘‘General Device
applicable statutes and regulations. This (OMB) for review and clearance under Classification Questionnaire,’’ Form
guidance is not subject to Executive the Paperwork Reduction Act of 1995. FDA 3429. Both forms contain a series
Order 12866. DATES: Fax written comments on the of questions concerning the safety and
collection of information by September effectiveness of the device type.
II. Paperwork Reduction Act of 1995
7, 2018. In the Federal Register of March 25,
This guidance refers to previously ADDRESSES: To ensure that comments on 2014 (79 FR 16252), FDA issued a
approved collections of information that the information collection are received, proposed rule that would eliminate the
are subject to review by the Office of OMB recommends that written need for Forms FDA 3427 and 3429.
Management and Budget (OMB) under comments be faxed to the Office of However, because the proposed rule has
the Paperwork Reduction Act of 1995 Information and Regulatory Affairs, not been finalized, we continue to
(44 U.S.C. 3501–3520). The collections OMB, Attn: FDA Desk Officer, Fax: 202– include the forms in the burden
of information in 21 CFR part 314 for 395–7285, or emailed to oira_ estimate for this information collection.
submitting NDAs and abbreviated new submission@omb.eop.gov. All The reclassification provisions of the
drug applications, including comments should be identified with the FD&C Act serve primarily as a vehicle
supplemental applications and annual OMB control number 0910–0138. Also for manufacturers to seek
reports, have been approved under OMB include the FDA docket number found reclassification from a higher to a lower
control number 0910–0001. The in brackets in the heading of this class, thereby reducing the regulatory
collections of information in 21 CFR document. requirements applicable to a particular
parts 211 and 212 (current good device type, or to seek reclassification
manufacturing practices) have been FOR FURTHER INFORMATION CONTACT:
from a lower to a higher class, thereby
approved under OMB control numbers Amber Sanford, Office of Operations,
increasing the regulatory requirements
0910–0139 and 0910–0667. Food and Drug Administration, Three
applicable to that device type. If
White Flint North, 10A–12M, 11601
III. Electronic Access approved, petitions requesting
Landsdown St., North Bethesda, MD
classification from class III to class II or
Persons with access to the internet 20852, 301–796–8867, PRAStaff@
class I provide an alternative route to
may obtain the guidance at either fda.hhs.gov.
market in lieu of premarket approval for
https://www.fda.gov/Drugs/ SUPPLEMENTARY INFORMATION: In class III devices. If approved, petitions
GuidanceCompliance compliance with 44 U.S.C. 3507, FDA requesting reclassification from class I
RegulatoryInformation/Guidances/ has submitted the following proposed or II, to a different class, may increase
default.htm, or https://www.fda.gov/ collection of information to OMB for requirements.
BiologicsBloodVaccines/ review and clearance. In the Federal Register of March 07,
GuidanceCompliance 2018 (83 FR 9743), FDA published a 60-
RegulatoryInformation/Guidances/ Reclassification Petitions for Medical
Devices day notice requesting public comment
default.htm or https:// on the proposed collection of
www.regulations.gov. OMB Control Number 0910–0138— information. FDA received one
Dated: August 3, 2018. Extension comment.
Leslie Kux, Under sections 513(e) and (f), 514(b), The comment supports continued use
Associate Commissioner for Policy. 515(b), and 520(l) of the Federal Food, of Forms FDA 3427 and FDA 3429.
[FR Doc. 2018–16984 Filed 8–7–18; 8:45 am] Drug, and Cosmetic Act (FD&C Act) (21 Specifically, the commenter is
BILLING CODE 4164–01–P U.S.C. 360c(e) and (f), 360d(b), 360e(b), addressing the issue of discontinuing
and 360j(l)) and part 860 (21 CFR part the forms as previously referenced,
860), subpart C, FDA has the wherein FDA issued a proposed rule (79
DEPARTMENT OF HEALTH AND responsibility to collect data and FR 16252) to eliminate the need for the
HUMAN SERVICES information contained in forms. Because FDA is not
reclassification petitions. The discontinuing use of the forms at this
Food and Drug Administration reclassification provisions of the FD&C time, and this comment relates to the
Act allow any person to petition for proposed rule (79 FR 16252) and not to
[Docket No. FDA–2011–N–0776] the information collection itself, we
reclassification of a device from any of
the three classes, i.e., I, II, and III, to make no changes to this information
Agency Information Collection collection based on the comment.
another class. The reclassification
Activities; Submission for Office of The Center for Devices and
content regulation (§ 860.123) requires
Management and Budget Review; Radiological Health (CDRH) has
the submission of valid scientific
Comment Request; Reclassification continually maintained contact with
evidence demonstrating that the
Petitions for Medical Devices industry. Informal communications
proposed reclassification will provide a
AGENCY: Food and Drug Administration, reasonable assurance of safety and concerning the importance and effect of
HHS. effectiveness of the device type for its reclassification are provided primarily
ACTION: Notice. indications for use. through trade organizations, and via
The reclassification procedure CDRH’s website (https://www.fda.gov/
sradovich on DSK3GMQ082PROD with NOTICES

SUMMARY: The Food and Drug regulation requires the submission of MedicalDevices/default.htm).
Administration (FDA or we) is specific data when a manufacturer is FDA estimates the burden of this
announcing that a proposed collection petitioning for reclassification. This collection of information as follows:

VerDate Sep<11>2014 22:37 Aug 07, 2018 Jkt 244001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 E:\FR\FM\08AUN1.SGM 08AUN1

39106 Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Notices

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number Total Average
FDA Number of of responses Total
Activity/21 CFR section annual burden per
form No. respondents per respond- hours
responses response
ent

Supporting data for reclassification peti-
tion—21 CFR 860.123 ......................... ........................ 6 1 6 497 2,982
Supplemental Data Sheet ........................ 3427 6 1 6 1.5 9
General Device Classification Question-
naire ...................................................... 3429 6 1 6 1.5 9

Total .................................................. ........................ ........................ ........................ ........................ ........................ 3,000
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Based on reclassification petitions 560, Rockville, MD 20852, (240) 276– 560, Rockville, MD 20852, (240) 276–
received in the past 3 years, FDA 9567. 9567.
anticipates that six petitions will be
Correction Correction
submitted each year. The time required
to prepare and submit a reclassification In the Federal Register of July 27, In the Federal Register of July 27,
petition, including the time needed to 2018, in FR Vol. 83 No. 145, on page 2018, in FR Vol. 83 No. 145, on page
assemble supporting data, averages 500 35662, in the second column, correct 35662, in the second column, correct
hours per petition. This average is based the DATES and ADDRESSES captions to the DATES and ADDRESSES captions to
upon estimates by FDA administrative read: read:
and technical staff who: (1) Are familiar DATES: The meeting will be held on DATES: The meeting will be held on
with the requirements for submission of September 21, 2018, from 9:00 a.m. to September 21, 2018, from 9:00 a.m. to
a reclassification petition, (2) have 12:30 p.m. 12:30 p.m.
consulted and advised manufacturers on ADDRESSES: Hubert H. Humphrey
ADDRESSES: Hubert H. Humphrey
these requirements, and (3) have Building, 200 Independence Avenue
reviewed the documentation submitted. Building, 200 Independence Avenue
SW, Room 800, Washington, DC 20201. SW, Room 800, Washington, DC 20201.
The burden estimate for this
Dated: August 1, 2018. Dated: August 1, 2018.
information collection has not changed
Holli M. Richmond, Holli M. Richmond,
since the past OMB approval.
Executive Director, Office of the President’s Executive Director, Office of the President’s
Dated: August 2, 2018. Council on Sports, Fitness, and Nutrition,
Council on Sports, Fitness, and Nutrition,
Leslie Kux, U.S. Department of Health and Human
U.S. Department of Health and Human
Associate Commissioner for Policy. Services. Services.
[FR Doc. 2018–16983 Filed 8–7–18; 8:45 am] [FR Doc. 2018–16970 Filed 8–7–18; 8:45 am] [FR Doc. 2018–16969 Filed 8–7–18; 8:45 am]
BILLING CODE 4164–01–P BILLING CODE 4150–35–P
BILLING CODE 4150–35–P

DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND
HUMAN SERVICES HUMAN SERVICES HUMAN SERVICES

Meeting of the President’s Council on Meeting of the President’s Council on National Institutes of Health
Sports, Fitness, and Nutrition; Sports, Fitness, and Nutrition;
Correction National Institute of Nursing Research;
Correction
Notice of Meeting
AGENCY: Office of the Assistant AGENCY: Department of Health and Pursuant to section 10(d) of the
Secretary for Health, President’s Council Human Services, Office of the Secretary, Federal Advisory Committee Act, as
on Sports, Fitness, and Nutrition, Office Office of the Assistant Secretary for amended, notice is hereby given of a
of the Secretary, Department of Health Health, President’s Council on Sports, meeting of the National Advisory
and Human Services. Fitness, and Nutrition. Council for Nursing Research.
ACTION: Notice of meeting; correction. ACTION: Notice of meeting; correction. The meeting will be open to the
public as indicated below, with
SUMMARY: The Department of Health and SUMMARY: The Department of Health and attendance limited to space available.
Human Services published a document Human Services published a document Individuals who plan to attend and
in the Federal Register of July 27, 2018, in the Federal Register of July 27, 2018, need special assistance, such as sign
concerning the upcoming annual concerning the upcoming annual language interpretation or other
meeting of the President’s Council on meeting of the President’s Council on reasonable accommodations, should
Sports, Fitness, and Nutrition (PCSFN). Sports, Fitness, and Nutrition (PCSFN).
sradovich on DSK3GMQ082PROD with NOTICES

notify the Contact Person listed below
The document contained an incorrect The document contained an incorrect in advance of the meeting.
location and time. location and time. The meeting will be closed to the
FOR FURTHER INFORMATION CONTACT: Ms. FOR FURTHER INFORMATION CONTACT: Ms. public in accordance with the
Holli M. Richmond, Executive Director, Holli M. Richmond, Executive Director, provisions set forth in sections
Office of the President’s Council on Office of the President’s Council on 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Sports, Fitness, and Nutrition, Tower Sports, Fitness, and Nutrition, Tower as amended. The grant applications and
Building, 1101 Wootton Parkway, Suite Building, 1101 Wootton Parkway, Suite the discussions could disclose

VerDate Sep<11>2014 22:37 Aug 07, 2018 Jkt 244001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 E:\FR\FM\08AUN1.SGM 08AUN1

Document Created: 2018-08-08 02:04:39
Document Modified: 2018-08-08 02:04:39

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.
Dates		Fax written comments on the collection of information by September 7, 2018.
Contact		Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected]
FR Citation		83 FR 39105

83 FR 39105 - [Docket No. FDA-2011-N-0776] HEADAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reclassification Petitions for Medical Devices

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 153 (August 8, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration