80 FR 65779 - Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Submission of Medical Device Registration and Listing
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 207 (October 27, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 207 (October 27, 2015)
| Page Range | 65779-65781 | |
| FR Document | 2015-27199 |
[Federal Register Volume 80, Number 207 (Tuesday, October 27, 2015)] [Notices] [Pages 65779-65781] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-27199] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-3815] Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Submission of Medical Device Registration and Listing AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with electronic submission of medical device registration and listing. DATES: Submit either electronic or written comments on the collection of information by December 28, 2015. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 [[Page 65780]] information, or other information that identifies you in the body of your comments, that information will be posted on http://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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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-2015-N-3815 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Submission of Medical Device Registration and Listing.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov. Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 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: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Electronic Submission of Medical Device Registration and Listing--21 CFR Part 807, Subparts A Through E; 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 [[Page 65781]] 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.'' FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Average 21 CFR section FDA form No. Number of responses per Total annual burden per Total hours respondents respondent responses response -------------------------------------------------------------------------------------------------------------------------------------------------------- 807.20(a)(5) \2\--Submittal of manufacturer information 3673 8,594 1 8,594 1.75 15,040 by initial importers................................... 807.20(a)(5) \3\--Submittal of manufacturer information 3673 8,594 3 25,782 0.1 2,578 by initial importers................................... 807.21(a) \3\--Creation of electronic system account.... 3673 3,559 1 3,559 0.5 1,780 807.21(b) \2\--Annual request for waiver from electronic .............. 14 1 14 1 14 registration & listing................................. 807.21(b) \3\--Initial request for waiver from .............. 4 1 4 1 4 electronic registration & listing...................... 807.22(a) \3\--Initial registration & listing........... 3673 3,539 1 3,539 0.5 1,770 807.22(b)(1) \3\--Annual registration................... 3673 20,355 1 20,355 0.75 15,266 807.22(b)(2) \3\--Other updates of registration......... 3673 4,176 1 4,176 0.5 2,088 807.22(b)(3) \3\--Annual update of listing information.. 3673 19,875 1 19,875 1 19,875 807.26(e) \3\--Labeling & advertisement submitted at FDA .............. 71 1 71 1 71 request................................................ 807.34(a) \2\--Initial registration & listing when .............. 14 1 14 1 14 electronic filing waiver granted....................... 807.34(a) \3\--Annual registration & listing when .............. 4 1 4 1 4 electronic filing waiver granted....................... 807.40(b)(2) \3\--Annual update of US agent information. 3673 1,615 1 1,615 0.5 808 807.40(b)(3) \3\--US agent responses to FDA requests for 3673 1,535 1 1,535 0.25 384 information............................................ 807.41(a) \3\--Identification of initial importers by 3673 10,329 1 10,329 0.5 5,165 foreign establishments................................. 807.41(b) \3\--Identification of other parties that 3673 10,329 1 10,329 0.5 5,165 facilitate import by foreign establishments............ ----------------------------------------------------------------------------------------------- Total on-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 21 CFR section Number of records per Total annual burden per Total hours recordkeepers recordkeeper records recordkeeping ---------------------------------------------------------------------------------------------------------------- 807.25(d) \2\--List of Officers, 23,806 1 23,806 0.25 5,952 Directors & Partners........... 807.26 \2\--Labeling & 11,746 4 46,984 0.5 23,492 Advertisements Available 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: October 21, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-27199 Filed 10-26-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 207 / Tuesday, October 27, 2015 / Notices 65779
Based on FDA’s review of current TABLE 1—Continued DeviceRegulationandGuidance/
scientific literature, FDA would not GuidanceDocuments/UCM080199.pdf.
consider the determination of carrier Tyrosinemia Type I
Usher Syndrome Type 1F Dated: October 20, 2015.
status by detection of clinically relevant
Usher Syndrome Type III Leslie Kux,
gene mutations associated with the Zellweger Syndrome Spectrum
diseases and conditions listed in Table Associate Commissioner for Policy.
1 to constitute a different intended use [FR Doc. 2015–27198 Filed 10–26–15; 8:45 am]
Exemption from the requirement of
from that of a legally marketed device in premarket notification does not exempt
BILLING CODE 4164–01–P
the generic type 21 CFR 866.5940 for a device from other applicable
purposes of § 866.9(a). Thus such uses regulatory controls under the FD&C Act,
would be 510(k)-exempt once there is DEPARTMENT OF HEALTH AND
including the applicable general and HUMAN SERVICES
compliance with special controls. A special controls. Indeed, FDA’s decision
gene mutation detection system to propose 510(k) exemption for these Food and Drug Administration
indicated for the determination of devices is based, in part, on the special
carrier status by detection of clinically controls, in combination with general [Docket No. FDA–2015–N–3815]
relevant gene mutations associated with controls, providing sufficiently rigorous
Cystic Fibrosis is not 510(k)-exempt Agency Information Collection
mitigations for the risks identified for Activities; Proposed Collection;
since it is a class II device subject to this generic type.
premarket notification and special Comment Request; Electronic
Subject to the limitations described Submission of Medical Device
controls under 21 CFR 866.5900—Cystic previously, FDA has determined that
fibrosis transmembrane conductance Registration and Listing
the requirement of premarket
regulator (CFTR) gene mutation notification is not necessary to assure AGENCY: Food and Drug Administration,
detection system. the safety and effectiveness of an HHS.
autosomal recessive carrier screening ACTION: Notice of availability.
TABLE 1 gene mutation detection system.
Accordingly, FDA is announcing its SUMMARY: The Food and Drug
Beta Thalassemia Administration (FDA) is announcing an
Bloom Syndrome
intent to exempt from the premarket
notification requirements autosomal opportunity for public comment on the
Canavan Disease proposed collection of certain
Congenital Disorder of Glycosylation Type 1a recessive carrier screening gene
(PMM2–CDG) mutation detection systems, subject to information by the Agency. Under the
Autosomal Recessive Connexin 26- the limitations described previously. Paperwork Reduction Act of 1995 (the
Nonsyndromic Hearing Loss FDA is publishing this notice in order PRA), Federal Agencies are required to
D-Bifunctional Protein Deficiency to obtain comments regarding the publish notice in the Federal Register
Dihydrolipoamide Dehydrogenase Deficiency proposed exemption. concerning each proposed collection of
Familial Dysautonomia information, including each proposed
Familial Mediterranean Fever V. Paperwork Reduction Act of 1995 extension of an existing collection of
Fanconi Anemia Group C information, and to allow 60 days for
Gaucher Disease This notice refers to previously
Glycogen Storage Disease Type 1 (1a and approved collections of information public comment in response to the
1b) found in FDA regulations. These notice. This notice solicits comments on
Gracile Syndrome collections of information are subject to information collection associated with
Hereditary Fructose Intolerance review by the Office of Management and electronic submission of medical device
Junctional Epidermolysis Bullosa (LAMB3-re- Budget (OMB) under the Paperwork registration and listing.
lated) Reduction Act of 1995 (44 U.S.C. 3501– DATES: Submit either electronic or
Leigh Syndrome, French Canadian Type written comments on the collection of
3520). The collections of information in
(LSFC)
Autosomal Recessive Limb-girdle Muscular 21 CFR part 807, subpart, E have been information by December 28, 2015.
Dystrophy approved under OMB control number ADDRESSES: You may submit comments
Maple Syrup Urine Disease 0910–0120 and the collections of as follows:
Medium-Chain Acyl-CoA Dehydrogenase information in 21 CFR parts 801 and
(MCAD) Deficiency 809 have been approved under OMB Electronic Submissions
Mucolipidosis IV control number 0910–0485. Submit electronic comments in the
Autosomal Recessive Neuronal Ceroid following way:
Lipofuscinosis (CLN5-related) VI. Reference • Federal eRulemaking Portal: http://
Autosomal Recessive Neuronal Ceroid www.regulations.gov. Follow the
The following reference is on display
Lipofuscinosis (PPT1-related)
in the Division of Dockets Management instructions for submitting comments.
Niemann-Pick Disease—Type A
Nijmegen Breakage Syndrome (see ADDRESSES) and is available for Comments submitted electronically,
Pendred Syndrome viewing by interested persons between including attachments, to http://
Phenylketonuria 9 a.m. and 4 p.m., Monday through www.regulations.gov will be posted to
Autosomal Recessive Polycystic Kidney Dis- Friday; it is also available electronically the docket unchanged. Because your
ease at http://www.regulations.gov. FDA has comment will be made public, you are
Primary Hyperoxaluria Type 2 (PH2) verified the Web site address, as of the solely responsible for ensuring that your
Rhizomelic Chondrodysplasia Punctata Type date this document publishes in the comment does not include any
1 (RCDP1)
tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register, but Web sites are confidential information that you or a
Salla Disease
subject to change over time. third party may not wish to be posted,
Sickle Cell Anemia
Sjögren-Larsson Syndrome 1. ‘‘Procedures for Class II Device such as medical information, your or
Autosomal Recessive Spastic Ataxia of Exemptions from Premarket Notification, anyone else’s Social Security number, or
Charlevoix-Saguenay (ARSACS) Guidance for Industry and CDRH Staff,’’ confidential business information, such
Spinal Muscular Atrophy February 1998, available at http:// as a manufacturing process. Please note
Tay Sachs Disease www.fda.gov/downloads/MedicalDevices/ that if you include your name, contact
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![Federal Register / Vol. 80, No. 207 / Tuesday, October 27, 2015 / Notices 65781
rule entitled ‘‘Implementation of Device Response Act of 2002, the Medical Drug Administration Amendments Act
Registration and Listing Requirements Device User Fee and Modernization Act of 2007.’’
Enacted in the Public Health Security of 2002, and Title II of the Food and FDA estimates the burden of this
and Bioterrorism Preparedness and collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
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 manufacturer information by ini-
tial importers .......................................................................... 3673 8,594 1 8,594 1.75 15,040
807.20(a)(5) 3—Submittal of manufacturer information by ini-
tial importers .......................................................................... 3673 8,594 3 25,782 0.1 2,578
807.21(a) 3—Creation of electronic system account ................ 3673 3,559 1 3,559 0.5 1,780
807.21(b) 2—Annual request for waiver from electronic reg-
istration & listing .................................................................... ........................ 14 1 14 1 14
807.21(b) 3—Initial request for waiver from electronic registra-
tion & listing ........................................................................... ........................ 4 1 4 1 4
807.22(a) 3—Initial registration & listing .................................... 3673 3,539 1 3,539 0.5 1,770
807.22(b)(1) 3—Annual registration ........................................... 3673 20,355 1 20,355 0.75 15,266
807.22(b)(2) 3—Other updates of registration ........................... 3673 4,176 1 4,176 0.5 2,088
807.22(b)(3) 3—Annual update of listing information ................ 3673 19,875 1 19,875 1 19,875
807.26(e) 3—Labeling & advertisement submitted at FDA re-
quest ...................................................................................... ........................ 71 1 71 1 71
807.34(a) 2—Initial registration & listing when electronic filing
waiver granted ....................................................................... ........................ 14 1 14 1 14
807.34(a) 3—Annual registration & listing when electronic fil-
ing waiver granted ................................................................. ........................ 4 1 4 1 4
807.40(b)(2) 3—Annual update of US agent information .......... 3673 1,615 1 1,615 0.5 808
807.40(b)(3) 3—US agent responses to FDA requests for in-
formation ................................................................................ 3673 1,535 1 1,535 0.25 384
807.41(a) 3—Identification of initial importers by foreign estab-
lishments ................................................................................ 3673 10,329 1 10,329 0.5 5,165
807.41(b) 3—Identification of other parties that facilitate import
by foreign establishments ...................................................... 3673 10,329 1 10,329 0.5 5,165
Total on-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 & Partners ............................................... 23,806 1 23,806 0.25 5,952
807.26 2—Labeling & Advertisements Available for Review ................................ 11,746 4 46,984 0.5 23,492
Total ............................................................................................................... ........................ ........................ ........................ ........................ 29,444
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 Recurring burden.
Dated: October 21, 2015. DEPARTMENT OF HEALTH AND Compounding Using Bulk Drug
Leslie Kux, HUMAN SERVICES Substances Under Section 503A of the
Associate Commissioner for Policy. Federal Food, Drug, and Cosmetic Act.’’
Food and Drug Administration The draft guidance describes FDA’s
[FR Doc. 2015–27199 Filed 10–26–15; 8:45 am]
interim regulatory policy regarding the
BILLING CODE 4164–01–P [Docket No. FDA–2015–D–3517] use of bulk drug substances by licensed
pharmacists in State-licensed
Interim Policy on Compounding Using pharmacies or Federal facilities and by
Bulk Drug Substances Under Section licensed physicians to compound
503A of the Federal Food, Drug, and human drug products while FDA
Cosmetic Act; Draft Guidance; develops the list of bulk drug substances
Availability that can be used in compounding under
AGENCY: Food and Drug Administration, the Federal Food, Drug, and Cosmetic
tkelley on DSK3SPTVN1PROD with NOTICES
HHS. Act (FD&C Act). When final, the
ACTION: Notice of availability. guidance will reflect the Agency’s
current thinking on the issues addressed
SUMMARY: The Food and Drug by the guidance.
Administration (FDA or Agency) is DATES: Although you can comment on
announcing the availability of a draft any guidance at any time (see 21 CFR
guidance entitled ‘‘Interim Policy on 10.115(g)(5)), to ensure that the Agency
VerDate Sep<11>2014 18:24 Oct 26, 2015 Jkt 238001 PO 00000 Frm 00095 Fmt 4703 Sfmt 4703 E:\FR\FM\27OCN1.SGM 27OCN1](https://thefederalregister.org/doc/80_FR_65986/page/3.svg)
Document Created: 2015-12-14 15:36:37
Document Modified: 2015-12-14 15:36:37
| 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 collection of information by December 28, 2015. | |
| 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 | 80 FR 65779 |
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