81 FR 40315 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Accessories
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 119 (June 21, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 119 (June 21, 2016)
| Page Range | 40315-40316 | |
| FR Document | 2016-14562 |
[Federal Register Volume 81, Number 119 (Tuesday, June 21, 2016)] [Notices] [Pages 40315-40316] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-14562] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-1593] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Accessories AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) 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 (the PRA). DATES: Fax written comments on the collection of information by July 21, 2016. 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-NEW and title ``Medical Device Accessories.'' Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [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. Medical Device Accessories--OMB Control Number 0910-NEW The draft guidance encourages manufacturers and other parties to utilize the process defined in section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to request risk- and regulatory control-based classifications of new types of accessories. This process provides a pathway to class I or class II classification for accessory devices for which general controls, or general and special controls, provide a reasonable assurance of safety and effectiveness, but for which there is no legally marketed predicate device. In accordance with section 513(f)(2) of the FD&C Act, manufacturers and other parties may submit a de novo requesting FDA to make a classification determination for the accessory device according to the criteria in section 513(a)(1) of the FD&C Act. The de novo must include a description of the device and detailed information and reasons for any recommended classification (see section 513(f)(2)(A)(v) of the FD&C Act). In the Federal Register of January 20, 2015 (80 FR 2710), FDA published a 60-day notice requesting public comment on the proposed collection of information. We received a total of 12 comments on the guidance. Of these the following were related to the information collection: Two comments raised concerns regarding the possible difficulties for manufacturers to submit a de novo for new accessories and for risk- and regulatory control-based classification of accessories that were approved under the premarket approval application (PMA) for the parent medical devices. One comment questioned whether FDA considered the possible ``practical and economic impact'' of the proposed definition of ``accessories'' that may result in manufacturers being obligated to list some components as accessories for FDA's registration and listing process. The second comment anticipates that ``few companies are likely to pursue this route given the associated costs and minimal advantage in time to market.'' Neither comment specifically discusses the potential PRA burden hours of voluntarily submitting a de novo application; however, it may be inferred that this could impact their resources under the PRA for submitting a de novo. Also, FDA is not proposing to limit or remove any mechanism that currently exists for manufacturers to obtain marketing authorization for accessories. De novos are typically less burdensome than PMAs for the purpose of classifying a new accessory. Furthermore, if a manufacturer wishes for an accessory to remain in the same regulatory class as the parent device, that manufacturer may continue to submit the accessory for clearance or [[Page 40316]] approval under the submission type applicable to the parent device. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Activity Number of responses per Total annual Average burden Total hours respondents respondent responses per response -------------------------------------------------------------------------------------------------------------------------------------------------------- Accessory classification de novo request........................... 8 1 8 180 1,440 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Respondents are medical device manufacturers seeking to market device accessories. Of the approximately 41 de novo applications received per year, only 2 have been associated with accessories. With heightened awareness of the availability of the de novo pathway for accessories, we expect to receive four to six additional accessories applications per year. Therefore, we estimate that we will receive approximately eight accessory classification de novo requests per year. Based on estimates by FDA administrative and technical staff who are familiar with the proposed submission process for accessory classification requests and on our burden estimate for a similar information collection request (see ``De Novo Classification Process Evaluation of Automatic Class III Designation; Draft Guidance for Industry and Food and Drug Administration Staff; Availability,'' 79 FR 47651 at 47653, August 14, 2014), we estimate that the submission process for each accessory classification request will take approximately 180 hours. The draft guidance also refers to previously approved collections of information found in FDA regulations. 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 807, subpart E have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 814 have been approved under OMB control number 0910-0231; and the collections of information in 21 CFR part 860, subpart C, have been approved under OMB control number 0910-0138. Dated: June 15, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-14562 Filed 6-20-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 119 / Tuesday, June 21, 2016 / Notices 40315
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Description and 21 CFR section FDA form No. responses per burden per Total hours
respondents responses
respondent response
Registrations or Updates, § 118.11 ... Form FDA 3733 2 300 1 300 2.3 690
Cancellations, § 118.11 ...................... Form FDA 3733 ... 30 1 30 1 30
Total ............................................ .............................. ........................ ........................ ........................ ........................ 720
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 The term ‘‘Form FDA 3733’’ refers to both the paper version of the form and the electronic system known as the Shell Egg Producer Reg-
istration Module, which is available at http://www.access.fda.gov per § 118.11(b)(1).
This estimate is based on the average information has been submitted to the FDA to make a classification
number of new shell egg producer Office of Management and Budget determination for the accessory device
registrations and cancellations received (OMB) for review and clearance under according to the criteria in section
in the past 3 years under § 118.11. We the Paperwork Reduction Act of 1995 513(a)(1) of the FD&C Act. The de novo
estimate that we will receive an average (the PRA). must include a description of the device
of 300 registrations or updates per year DATES: Fax written comments on the and detailed information and reasons
over the next 3 years. Based on the collection of information by July 21, for any recommended classification (see
number of cancellations previously 2016. section 513(f)(2)(A)(v) of the FD&C Act).
received, we estimate that we will In the Federal Register of January 20,
ADDRESSES: To ensure that comments on
receive approximately 30 cancellations 2015 (80 FR 2710), FDA published a 60-
the information collection are received,
per year over the next 3 years. day notice requesting public comment
OMB recommends that written
We estimate that it takes the average on the proposed collection of
comments be faxed to the Office of
farm 2.3 hours to register, taking into information. We received a total of 12
Information and Regulatory Affairs,
account that some respondents comments on the guidance. Of these the
OMB, Attn: FDA Desk Officer, FAX:
completing the registration may not following were related to the
202–395–7285, or emailed to oira_
have readily available Internet access. information collection:
submission@omb.eop.gov. All
Thus, the total annual burden for new
comments should be identified with the Two comments raised concerns
shell egg producer registrations or
OMB control number 0910–NEW and regarding the possible difficulties for
updates is calculated to be 690 hours
title ‘‘Medical Device Accessories.’’ Also manufacturers to submit a de novo for
(300 × 2.3 hours).
We estimate cancelling a registration, include the FDA docket number found new accessories and for risk- and
in brackets in the heading of this regulatory control-based classification of
on average, requires a burden of
document. accessories that were approved under
approximately 1 hour, taking into
account that some respondents may not FOR FURTHER INFORMATION CONTACT: FDA the premarket approval application
have readily available Internet access. PRA Staff, Office of Operations, Food (PMA) for the parent medical devices.
Thus, the total annual burden for and Drug Administration, 8455 One comment questioned whether FDA
cancelling shell egg producer Colesville Rd., COLE–14526, Silver considered the possible ‘‘practical and
registrations is calculated to be 30 hours Spring, MD 20993–0002, PRAStaff@ economic impact’’ of the proposed
(30 cancellations × 1 hour). fda.hhs.gov. definition of ‘‘accessories’’ that may
result in manufacturers being obligated
Dated: June 15, 2016. SUPPLEMENTARY INFORMATION: In
to list some components as accessories
Leslie Kux, compliance with 44 U.S.C. 3507, FDA for FDA’s registration and listing
Associate Commissioner for Policy. has submitted the following proposed
process. The second comment
collection of information to OMB for
[FR Doc. 2016–14584 Filed 6–20–16; 8:45 am] anticipates that ‘‘few companies are
review and clearance.
BILLING CODE 4164–01–P likely to pursue this route given the
Medical Device Accessories—OMB associated costs and minimal advantage
Control Number 0910–NEW in time to market.’’ Neither comment
DEPARTMENT OF HEALTH AND The draft guidance encourages specifically discusses the potential PRA
HUMAN SERVICES manufacturers and other parties to burden hours of voluntarily submitting
utilize the process defined in section a de novo application; however, it may
Food and Drug Administration be inferred that this could impact their
513(f)(2) of the Federal Food, Drug, and
[Docket No. FDA–2016–N–1593] Cosmetic Act (the FD&C Act) to request resources under the PRA for submitting
risk- and regulatory control-based a de novo.
Agency Information Collection classifications of new types of Also, FDA is not proposing to limit or
Activities; Submission for Office of accessories. This process provides a remove any mechanism that currently
Management and Budget Review; pathway to class I or class II exists for manufacturers to obtain
Comment Request; Medical Device classification for accessory devices for marketing authorization for accessories.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Accessories which general controls, or general and De novos are typically less burdensome
AGENCY: Food and Drug Administration, special controls, provide a reasonable than PMAs for the purpose of
HHS. assurance of safety and effectiveness, classifying a new accessory.
ACTION: Notice. but for which there is no legally Furthermore, if a manufacturer wishes
marketed predicate device. for an accessory to remain in the same
SUMMARY: The Food and Drug In accordance with section 513(f)(2) of regulatory class as the parent device,
Administration (FDA) is announcing the FD&C Act, manufacturers and other that manufacturer may continue to
that a proposed collection of parties may submit a de novo requesting submit the accessory for clearance or
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![40316 Federal Register / Vol. 81, No. 119 / Tuesday, June 21, 2016 / Notices
approval under the submission type FDA estimates the burden of this
applicable to the parent device. collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response
Accessory classification de novo request ............................ 8 1 8 180 1,440
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Respondents are medical device DEPARTMENT OF HEALTH AND confidential information that you or a
manufacturers seeking to market device HUMAN SERVICES third party may not wish to be posted,
accessories. Of the approximately 41 de such as medical information, your or
novo applications received per year, Food and Drug Administration anyone else’s Social Security number, or
only 2 have been associated with [Docket No. FDA–2014–E–2335] confidential business information, such
accessories. With heightened awareness as a manufacturing process. Please note
of the availability of the de novo Determination of Regulatory Review that if you include your name, contact
pathway for accessories, we expect to Period for Purposes of Patent information, or other information that
receive four to six additional accessories Extension; XOFIGO identifies you in the body of your
comments, that information will be
applications per year. Therefore, we AGENCY: Food and Drug Administration, posted on http://www.regulations.gov.
estimate that we will receive HHS. • If you want to submit a comment
approximately eight accessory with confidential information that you
ACTION: Notice.
classification de novo requests per year. do not wish to be made available to the
Based on estimates by FDA SUMMARY: The Food and Drug public, submit the comment as a
administrative and technical staff who Administration (FDA) has determined written/paper submission and in the
are familiar with the proposed the regulatory review period for manner detailed (see ‘‘Written/Paper
submission process for accessory XOFIGO and is publishing this notice of Submissions’’ and ‘‘Instructions’’).
classification requests and on our that determination as required by law.
FDA has made the determination Written/Paper Submissions
burden estimate for a similar
information collection request (see ‘‘De because of the submission of an Submit written/paper submissions as
Novo Classification Process Evaluation application to the Director of the U.S. follows:
of Automatic Class III Designation; Draft Patent and Trademark Office (USPTO), • Mail/Hand delivery/Courier (for
Guidance for Industry and Food and Department of Commerce, for the written/paper submissions): Division of
extension of a patent which claims that Dockets Management (HFA–305), Food
Drug Administration Staff;
human drug product. and Drug Administration, 5630 Fishers
Availability,’’ 79 FR 47651 at 47653,
DATES: Anyone with knowledge that any
Lane, Rm. 1061, Rockville, MD 20852.
August 14, 2014), we estimate that the • For written/paper comments
submission process for each accessory of the dates as published (in the
submitted to the Division of Dockets
classification request will take SUPPLEMENTARY INFORMATION section) are
Management, FDA will post your
approximately 180 hours. incorrect may submit either electronic
comment, as well as any attachments,
or written comments and ask for a except for information submitted,
The draft guidance also refers to redetermination by August 22, 2016.
previously approved collections of marked and identified, as confidential,
Furthermore, any interested person may if submitted as detailed in
information found in FDA regulations. petition FDA for a determination
The collections of information in 21 ‘‘Instructions.’’
regarding whether the applicant for Instructions: All submissions received
CFR parts 801 and 809 have been extension acted with due diligence must include the Docket No. FDA–
approved under OMB control number during the regulatory review period by 2014–E–2335 for ‘‘Determination of
0910–0485; the collections of December 19, 2016. See ‘‘Petitions’’ in Regulatory Review Period for Purposes
information in 21 CFR part 807, subpart the SUPPLEMENTARY INFORMATION section of Patent Extension; XOFIGO.’’ Received
E have been approved under OMB for more information. comments will be placed in the docket
control number 0910–0120; the ADDRESSES: You may submit comments and, except for those submitted as
collections of information in 21 CFR as follows: ‘‘Confidential Submissions,’’ publicly
part 814 have been approved under viewable at http://www.regulations.gov
OMB control number 0910–0231; and Electronic Submissions
or at the Division of Dockets
the collections of information in 21 CFR Submit electronic comments in the Management between 9 a.m. and 4 p.m.,
part 860, subpart C, have been approved following way: Monday through Friday.
under OMB control number 0910–0138. • Federal eRulemaking Portal: http:// • Confidential Submissions—To
www.regulations.gov. Follow the submit a comment with confidential
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Dated: June 15, 2016.
instructions for submitting comments. information that you do not wish to be
Leslie Kux, Comments submitted electronically, made publicly available, submit your
Associate Commissioner for Policy. including attachments, to http:// comments only as a written/paper
[FR Doc. 2016–14562 Filed 6–20–16; 8:45 am] www.regulations.gov will be posted to submission. You should submit two
BILLING CODE 4164–01–P the docket unchanged. Because your copies total. One copy will include the
comment will be made public, you are information you claim to be confidential
solely responsible for ensuring that your with a heading or cover note that states
comment does not include any ‘‘THIS DOCUMENT CONTAINS
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Document Created: 2016-06-21 01:30:41
Document Modified: 2016-06-21 01:30:41
| 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 July 21, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 81 FR 40315 |
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