81 FR 13801 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Submission of Medical Device Registration and Listing
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 50 (March 15, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 50 (March 15, 2016)
| Page Range | 13801-13802 | |
| FR Document | 2016-05744 |
[Federal Register Volume 81, Number 50 (Tuesday, March 15, 2016)] [Notices] [Pages 13801-13802] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-05744] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-3815] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Submission of Medical Device Registration and Listing 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. DATES: Fax written comments on the collection of information by April 14, 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 0910-0625. 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. Electronic Submission of Medical Device Registration and Listing--21 CFR Part 807, Subparts A Through D; OMB Control Number 0910-0625-- Extension Under section 510 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360) and part 807, subparts A through D (21 CFR part 807, subparts A through D), medical device establishment owners and operators are required to electronically submit establishment registration and device listing information. Complete and accurate registration and listing information is necessary to accomplish a number of statutory and regulatory objectives, such as: (1) Identification of establishments producing marketed medical devices, (2) identification of establishments producing a specific device when that device is in short supply or is needed for national emergency, (3) facilitation of recalls for devices marketed by owners and operators of device establishments, (4) identification and cataloguing of marketed devices, (5) administering postmarketing surveillance programs for devices, (6) identification of devices marketed in violation of the law, (7) identification and control of devices imported into the country from foreign establishments, (8) and scheduling and planning inspections of registered establishments under section 704 of the FD&C Act (21 U.S.C. 374). Respondents to this information collection are owners or operators of establishments that engage in the manufacturing, preparation, propagation, compounding, or processing of a device or devices, who must register their establishments and submit listing information for each of their devices in commercial distribution. Notwithstanding certain exceptions, foreign device establishments that manufacture, prepare, propagate, compound, or process a device that is imported or offered for import into the United States must also comply with the registration and listing requirements. The number of respondents is based on data from the FDA Unified Registration and Listing System. Burden estimates are based on recent experience with the existing medical device registration and listing program, electronic system operating experience, and the economic analysis for the final rule entitled ``Implementation of Device Registration and Listing Requirements Enacted in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, the Medical Device User Fee and Modernization Act of 2002, and Title II of the Food and Drug Administration Amendments Act of 2007.'' In the Federal Register of October 27, 2015 (80 FR 65779), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of 21 CFR Section FDA Form No. Number of responses per Total annual Average burden per response Total hours respondents respondent responses -------------------------------------------------------------------------------------------------------------------------------------------------------- 807.20(a)(5) \2\--Submittal of 3673 8,594 1 8,594 1.75.......................... 15,040 manufacturer information by initial importers. 807.20(a)(5) \3\--Submittal of 3673 8,594 3 25,782 .1............................ 2,578 manufacturer information by initial (6 minutes)................... importers. [[Page 13802]] 807.21(a) \3\--Creation of electronic 3673 3,559 1 3,559 .5............................ 1,780 system account. (30 minutes).................. 807.21(b) \2\--Annual request for waiver .............. 14 1 14 1............................. 14 from electronic registration and listing. 807.21(b) \3\--Initial request for .............. 4 1 4 1............................. 4 waiver from electronic registration and listing. 807.22(a) \3\--Initial registration and 3673 3,539 1 3,539 .5............................ 1,770 listing. (30 minutes).................. 807.22(b)(1) \3\--Annual registration... 3673 20,355 1 20,355 .75........................... 15,266 (45 minutes).................. 807.22(b)(2) \3\--Other updates of 3673 4,176 1 4,176 .5............................ 2,088 registration. (30 minutes).................. 807.22(b)(3) \3\--Annual update of 3673 19,875 1 19,875 1............................. 19,875 listing information. 807.26(e) \3\--Labeling and .............. 71 1 71 1............................. 71 advertisement submitted at FDA request. 807.34(a) \2\--Initial registration and .............. 14 1 14 1............................. 14 listing when electronic filing waiver granted. 807.34(a) \3\--Annual registration and .............. 4 1 4 1............................. 4 listing when electronic filing waiver granted. 807.40(b)(2) \3\--Annual update of U.S. 3673 1,615 1 1,615 .5............................ 808 agent information. (30 minutes).................. 807.40(b)(3) \3\--U.S. agent responses 3673 1,535 1 1,535 .25........................... 384 to FDA requests for information. (15 minutes).................. 807.41(a) \3\--Identification of initial 3673 10,329 1 10,329 .5............................ 5,165 importers by foreign establishments. (30 minutes).................. 807.41(b) \3\--Identification of other 3673 10,329 1 10,329 .5............................ 5,165 parties that facilitate import by (30 minutes).................. foreign establishments. --------------------------------------------------------------------------------------------------------------- Total one-time burden............... .............. .............. .............. .............. .............................. 15,068 --------------------------------------------------------------------------------------------------------------- Total recurring burden.............. .............. .............. .............. .............. .............................. 54,958 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. \2\ One-time burden. \3\ Recurring burden. Table 2--Estimated Annual Recordkeeping Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of 21 CFR Section Number of records per Total annual Average burden per Total hours recordkeepers recordkeeper records recordkeeping ---------------------------------------------------------------------------------------------------------------- 807.25(d) \2\--List of 23,806 1 23,806 .25............... 5,952 officers, directors and (30 minutes)...... partners. 807.26 \2\--Labeling and 11,746 4 46,984 .5................ 23,492 advertisements available (30 minutes)...... for review. ----------------------------------------------------------------------------------- Total................... .............. .............. .............. .................. 29,444 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. \2\ Recurring burden. Dated: March 9, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-05744 Filed 3-14-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 50 / Tuesday, March 15, 2016 / Notices 13801
0910–0338; the collections of SUMMARY: The Food and Drug device is in short supply or is needed
information in 21 CFR 606.65, 606.100, Administration (FDA) is announcing for national emergency, (3) facilitation
606.120, 606.121, 606.122, and have that a proposed collection of of recalls for devices marketed by
been approved under OMB control information has been submitted to the owners and operators of device
number 0910–0116; and the collections Office of Management and Budget establishments, (4) identification and
of information in 21 CFR part 607 have (OMB) for review and clearance under cataloguing of marketed devices, (5)
been approved under OMB control the Paperwork Reduction Act of 1995. administering postmarketing
number 0910–0052. DATES: Fax written comments on the surveillance programs for devices, (6)
To ensure that comments on collection of information by April 14, identification of devices marketed in
information collection are received, 2016. violation of the law, (7) identification
OMB recommends that written and control of devices imported into the
ADDRESSES: To ensure that comments on
comments be faxed to the Office of country from foreign establishments, (8)
the information collection are received,
Information and Regulatory Affairs, and scheduling and planning
OMB recommends that written
OMB (see ADDRESSES). All comments inspections of registered establishments
comments be faxed to the Office of
should be identified with the title of the under section 704 of the FD&C Act (21
Information and Regulatory Affairs,
information collection. U.S.C. 374).
OMB, Attn: FDA Desk Officer, FAX:
In compliance with the PRA (44 Respondents to this information
202–395–7285, or emailed to oira_
U.S.C. 3407(d)), the Agency has collection are owners or operators of
submission@omb.eop.gov. All
submitted the information collection establishments that engage in the
comments should be identified with the
provisions of this document to OMB for manufacturing, preparation,
OMB control number 0910–0625. Also
review. These requirements will not be propagation, compounding, or
include the FDA docket number found
effective until FDA obtains OMB processing of a device or devices, who
in brackets in the heading of this
approval. FDA will publish a notice must register their establishments and
document.
concerning OMB approval of these submit listing information for each of
requirements in the Federal Register. FOR FURTHER INFORMATION CONTACT: FDA their devices in commercial
PRA Staff, Office of Operations, Food distribution. Notwithstanding certain
III. Electronic Access and Drug Administration, 8455 exceptions, foreign device
Persons with access to the Internet Colesville Rd., COLE–14526, Silver establishments that manufacture,
may obtain the draft guidance at either Spring, MD 20993–0002, PRAStaff@ prepare, propagate, compound, or
http://www.fda.gov/BiologicsBlood fda.hhs.gov. process a device that is imported or
Vaccines/GuidanceCompliance SUPPLEMENTARY INFORMATION: In offered for import into the United States
RegulatoryInformation/Guidances/ compliance with 44 U.S.C. 3507, FDA must also comply with the registration
default.htm or http:// has submitted the following proposed and listing requirements. The number of
www.regulations.gov. collection of information to OMB for respondents is based on data from the
Dated: March 9, 2016. review and clearance. FDA Unified Registration and Listing
Leslie Kux, System.
Electronic Submission of Medical Burden estimates are based on recent
Associate Commissioner for Policy. Device Registration and Listing—21 experience with the existing medical
[FR Doc. 2016–05718 Filed 3–14–16; 8:45 am] CFR Part 807, Subparts A Through D; device registration and listing program,
BILLING CODE 4164–01–P OMB Control Number 0910–0625— electronic system operating experience,
Extension and the economic analysis for the final
DEPARTMENT OF HEALTH AND Under section 510 of the Federal rule entitled ‘‘Implementation of Device
HUMAN SERVICES Food, Drug, and Cosmetic Act (the Registration and Listing Requirements
FD&C Act) (21 U.S.C. 360) and part 807, Enacted in the Public Health Security
Food and Drug Administration subparts A through D (21 CFR part 807, and Bioterrorism Preparedness and
subparts A through D), medical device Response Act of 2002, the Medical
[Docket No. FDA–2015–N–3815] establishment owners and operators are Device User Fee and Modernization Act
required to electronically submit of 2002, and Title II of the Food and
Agency Information Collection establishment registration and device Drug Administration Amendments Act
Activities; Submission for Office of listing information. of 2007.’’
Management and Budget Review; Complete and accurate registration In the Federal Register of October 27,
Comment Request; Electronic and listing information is necessary to 2015 (80 FR 65779), FDA published a
Submission of Medical Device accomplish a number of statutory and 60-day notice requesting public
Registration and Listing regulatory objectives, such as: (1) comment on the proposed collection of
AGENCY: Food and Drug Administration, Identification of establishments information. No comments were
HHS. producing marketed medical devices, received.
(2) identification of establishments FDA estimates the burden of this
ACTION: Notice.
producing a specific device when that collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Number of Average
Number of Total annual
21 CFR Section FDA Form No. responses per burden per Total hours
respondents responses
respondent response
807.20(a)(5) 2—Submittal of manufac- 3673 8,594 1 8,594 1.75 ................ 15,040
turer information by initial importers.
807.20(a)(5) 3—Submittal of manufac- 3673 8,594 3 25,782 .1 .................... 2,578
turer information by initial importers. (6 minutes) .....
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![13802 Federal Register / Vol. 81, No. 50 / Tuesday, March 15, 2016 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of Average
Number of Total annual
21 CFR Section FDA Form No. responses per burden per Total hours
respondents responses
respondent response
807.21(a) 3—Creation of electronic sys- 3673 3,559 1 3,559 .5 .................... 1,780
tem account. (30 minutes) ...
807.21(b) 2—Annual request for waiver ........................ 14 1 14 1 ..................... 14
from electronic registration and listing.
807.21(b) 3—Initial request for waiver ........................ 4 1 4 1 ..................... 4
from electronic registration and listing.
807.22(a) 3—Initial registration and listing 3673 3,539 1 3,539 .5 .................... 1,770
(30 minutes) ...
807.22(b)(1) 3—Annual registration ......... 3673 20,355 1 20,355 .75 .................. 15,266
(45 minutes) ...
807.22(b)(2) 3—Other updates of reg- 3673 4,176 1 4,176 .5 .................... 2,088
istration. (30 minutes) ...
807.22(b)(3) 3—Annual update of listing 3673 19,875 1 19,875 1 ..................... 19,875
information.
807.26(e) 3—Labeling and advertisement ........................ 71 1 71 1 ..................... 71
submitted at FDA request.
807.34(a) 2—Initial registration and listing ........................ 14 1 14 1 ..................... 14
when electronic filing waiver granted.
807.34(a) 3—Annual registration and list- ........................ 4 1 4 1 ..................... 4
ing when electronic filing waiver grant-
ed.
807.40(b)(2) 3—Annual update of U.S. 3673 1,615 1 1,615 .5 .................... 808
agent information. (30 minutes) ...
807.40(b)(3) 3—U.S. agent responses to 3673 1,535 1 1,535 .25 .................. 384
FDA requests for information. (15 minutes) ...
807.41(a) 3—Identification of initial im- 3673 10,329 1 10,329 .5 .................... 5,165
porters by foreign establishments. (30 minutes) ...
807.41(b) 3—Identification of other par- 3673 10,329 1 10,329 .5 .................... 5,165
ties that facilitate import by foreign es- (30 minutes) ...
tablishments.
Total one-time burden ...................... ........................ ........................ ........................ ........................ ........................ 15,068
Total recurring burden ...................... ........................ ........................ ........................ ........................ ........................ 54,958
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 One-time burden.
3 Recurring burden.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
21 CFR Section records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping
807.25(d) 2—List of officers, directors and partners ............ 23,806 1 23,806 .25 .................. 5,952
(30 minutes) ...
807.26 2—Labeling and advertisements available for re- 11,746 4 46,984 .5 .................... 23,492
view. (30 minutes) ...
Total .............................................................................. ........................ ........................ ........................ ........................ 29,444
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 Recurring burden.
Dated: March 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–05744 Filed 3–14–16; 8:45 am]
BILLING CODE 4164–01–P
asabaliauskas on DSK3SPTVN1PROD with NOTICES
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Document Created: 2016-03-15 04:06:57
Document Modified: 2016-03-15 04:06:57
| 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 April 14, 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 13801 |
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