Document ID: FDA-2014-N-1048-0010
Agency: fda
Document Type: Notice
Title: Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Device
Labeling Regulations
Posted Date: 2021-10-08T04:00Z

[Federal Register Volume 86, Number 193 (Friday, October 8, 2021)]
[Notices]
[Pages 56274-56276]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-22043]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1048]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Medical Device 
Labeling Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, 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: Submit written comments (including recommendations) on the 
collection of information by November 8, 2021.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0485. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399, 
PRAStaff@fda.hhs.gov.

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 Labeling Regulations

OMB Control No. 0910-0485--Revision

    This information collection supports implementation of medical 
device labeling requirements governed by section 502 of the Federal 
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 352), codified in 
Agency regulations, and discussed in associated Agency guidance. 
Medical device labeling requirements, among other things, provide for 
the label or labeling content of a medical device so that it is not 
misbranded and subject to regulatory action. Certain provisions under 
section 502 of the FD&C Act require that manufacturers, importers, and 
distributors of medical devices disclose information about themselves 
or the devices on the labels or labeling for the devices. Section 502 
provides, in part, that a device shall be misbranded if, among other 
things, its label or labeling fails to bear certain required 
information concerning the device, is false or misleading in any 
particular way, or fails to contain adequate directions for use. 
Medical device labeling regulations in parts 800, 801, 809, and 
associated regulations in parts 660 and 1040 (21 CFR parts 660, 800, 
801, 809, and 1040), prescribe the disclosure of specific information 
by manufacturers, importers, and distributors of medical devices about 
themselves and/or the devices, on the label or labeling for the 
devices, to health professionals and consumers.
    In conjunction with provisions in part 800, part 801, subpart A 
sets forth general labeling provisions applicable to all medical 
devices, including content and format requirements pertaining to 
intended uses, adequate directions for use, misleading statements, and 
the prominence of required labeling. Provisions found in part 801, 
subpart B pertaining to labeling requirements for Unique Device 
Identification are currently approved under OMB control number 0910-
0720 and not covered in this information collection request. 
Information collection associated with labeling requirements for Over-
the-Counter (OTC) Devices are found in part 801, subpart C, and cover 
principal display panel; statement of identity; declaration of net 
quantity of contents; and certain warning statement elements. 
Information collection associated with exemptions from adequate 
directions for use and other exemptions are found in part 801, subparts 
D and E, respectively. Information collection associated with special 
labeling requirements applicable to specific devices are found in part 
801, subpart H. We also include information collection associated with 
labeling for in vitro diagnostic products for human use, as set forth 
in part 809, subpart B. In addition to the labeling requirements in 
part 801 and the certification and identification requirements of 21 
CFR 1010.2 and 1010.3, sunlamp products and ultraviolet lamps are 
subject to specific labeling requirements as set forth in part 1040.
    The information collection also includes provisions associated with 
stand-alone symbols (not accompanied by explanatory text adjacent to 
the symbol), when accompanied by a symbols glossary, as set forth in 
part 660, additional standards for diagnostic substances for laboratory 
standards for biological products, subparts A, C, D, E, and F. The 
requirements are also found in the general medical device labeling 
regulations part 801, subpart A, and part 809, subpart B.
    The information collection also helps to implement section 502(b) 
of the FD&C Act which requires that, for packaged devices, labeling 
must bear the name and place of business of the manufacturer, packer, 
or distributor; and an accurate statement of the quantity of the 
contents. Section 502(f) of the FD&C Act requires also that the 
labeling for a device must contain adequate directions for use unless 
FDA grants an exemption. Section 502(u) requires reprocessed single-use 
devices (SUDs) to bear prominently and conspicuously the name of the 
manufacturer, a generally recognized abbreviation of such name, or a 
unique and generally recognized symbol identifying the manufacturer. 
Under this provision, if the original SUD or an attachment to it 
prominently and conspicuously bears the name of the manufacturer, then 
the reprocessor of the SUD is required to identify itself by

[[Page 56275]]

name, abbreviation, or symbol in a prominent and conspicuous manner on 
the device or attachment to the device. If the original SUD does not 
prominently and conspicuously bear the name of the manufacturer, the 
manufacturer who reprocesses the SUD for reuse may identify itself 
using a detachable label that is intended to be affixed to the patient 
record. As required by the Medical Device User Fee Stabilization Act of 
2005 (MDUFSA), FDA issued the guidance document, ``Compliance with 
Section 301 of the Medical Device User Fee and Modernization Act of 
2002, as amended--Prominent and Conspicuous Mark of Manufacturers on 
Single-Use Devices'' (May 2006), to assist respondents with these 
requirements. The guidance document was issued consistent with our Good 
Guidance Practice regulations in 21 CFR 10.115, which provide for 
public comment at any time. We maintain a searchable guidance database 
on our website, and this guidance is available at https://www.fda.gov/media/71187/download. The guidance document is intended to identify 
circumstances in which the name or symbol of the original SUD 
manufacturer is not prominent and conspicuous, as used in section 
502(u) of the FD&C Act.
    In the Federal Register of July 13, 2021 (86 FR 36752), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                          21 CFR citation                               Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
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   Part 660, subparts A, C, D, E, and F: Antibody to Hepatitis B Surface Antigen; Blood Grouping Reagent; Reagent Red Blood Cells; Hepatitis B Surface
                            Antigen; Anti-Human Globulin; Part 801 subpart A: General Labeling; Part 809, subpart B: Labeling
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Symbols glossary--660.2; antibody to Hepatitis B surface antigen              3,000                1            3,000                1            3,000
 requirements, 660.28; blood grouping labeling, 660.35; reagent red
 blood cell labeling, 660.45, hepatitis B surface antigen labeling,
 660.55; anti-human globulin labeling, 801.15; medical devices
 labeling and use of symbols; 809.10, labeling for in vitro
 diagnostic products...............................................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Our figures are based on data from the FDA Unified Registration and 
Listing System and the OASIS shipment information. FDA regulations 
allow for the use of stand-alone graphical representations of 
information, or symbols, in the labeling for the medical devices and 
diagnostic substances for laboratory standards, if the symbol has been 
established in a Standards Development Organization developed standard, 
provided that such symbol is explained in a symbols glossary that is 
included in the labeling for the medical device and otherwise complies 
with section 502 (misbranding) of the FD&C Act. These labeling 
requirements are set forth in part 660, subparts A, C, D, E, and F, in 
the additional standards for diagnostic substances for laboratory 
standards for biological products, including: General requirements 
(Sec.  660.2), using antibody to Hepatitis B surface antigen (Sec.  
660.28), blood grouping reagent (Sec.  660.35), reagent red blood cells 
(Sec.  660.45), Hepatitis B surface antigen (Sec.  660.45); and anti-
human globulin (Sec.  660.55). The requirements are also found in the 
general medical device labeling regulations part 801, subpart A and in 
the in vitro diagnostic product labeling regulations part 809, subpart 
B.

                                                   Table 2--Estimated Annual Recordkeeping Burden 1 2
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                                                                 Number of
               21 CFR citation                   Number of      records per    Total annual        Average burden per recordkeeping         Total hours
                                               recordkeepers   recordkeeper       records
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           Part 801 subpart A: General Labeling Provisions; subpart E: Other Exemptions; subpart H: Special Requirements for Specific Devices
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Processing, labeling, or repacking                     7,500             887       6,652,500  0.5 (30 minutes)..........................       3,326,250
 agreement; 801.150.
Impact resistant lenses; invoices, shipping            1,591          47,050      74,856,550  0.0008 (0.048 minutes)....................          59,885
 documents, and records of sale or
 distribution; 801.410(e) and (f).
Hearing aid records; 801.421................          10,000             160       1,600,000  0.25 (15 minutes).........................         400,000
Menstrual tampons, sampling plan for                      33              11             363  80........................................          29,040
 measuring absorbency; 801.430(f).
Latex condoms; justification for the                      51            3.65             186  1.........................................             186
 application of testing data to the
 variation of the tested product; 801.435(g).
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............      83,109,599  ..........................................       3,815,361
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Numbers have been rounded.

    As set forth in Sec.  801.150(a)(2), device manufacturers are 
required to retain a copy of the agreement containing the 
specifications for the processing, labeling, or repacking of the device 
for 2 years after the final shipment or delivery of the device. Section 
801.150(a)(2) requires that copies of this agreement be made available 
for inspection at any reasonable hour upon request by any officer or 
employee of the Department of Health and Human Services (HHS). In Sec.  
801.410(e) copies of invoices, shipping documents, and records of sale 
or distribution of all impact resistant lenses, including finished 
eyeglasses and sunglasses, are required to be maintained for 3 years by 
the retailer and made available upon request by any officer or employee 
of FDA or by any other officer or employee

[[Page 56276]]

acting on behalf of the Secretary of HHS. Section 801.410(f) requires 
that the results of impact tests and description of the test method and 
apparatus be retained for a period of 3 years. Specific recordkeeping 
requirements applicable to hearing aid dispensers, manufacturers of 
menstrual tampons, and manufacturers of latex condoms are set forth in 
Sec. Sec.  801.421(d), 801.430(f), and 801.435(g), respectively.

                                               Table 3--Estimated Annual Third-Party Disclosure Burden 1 2
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                                                                 Number of
               21 CFR citation                   Number of      disclosures    Total annual          Average burden per disclosure          Total hours
                                                respondents   per respondent    disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
                               Part 800; and Part 801, subparts A, C, D, and E: General Labeling; OTC Devices; Exemptions
--------------------------------------------------------------------------------------------------------------------------------------------------------
Contact lens cleaning solution labeling;                  47               8             376  1.........................................             376
 800.10(a)(3) and 800.12(c).
Liquid ophthalmic preparation labeling;                   25               8             200  1.........................................             200
 800.10(b)(2).
Manufacturer, packer, or distributor                  19,407               7         135,849  1.........................................         135,849
 information; 801.1.
Adequate directions for use; 801.5..........           8,526               6          51,156  22.35 (22 hours and 21 minutes)...........       1,143,337
Statement of identity; 801.61...............           8,526               6          51,156  1.........................................          51,156
Declaration of net quantity of contents;               8,526               6          51,156  1.........................................          51,156
 801.62.
Prescription device labeling; 801.109.......           9,681               6          58,086  17.77 (17 hours and 46.2 minutes).........       1,032,188
Retail exemption for prescription devices;            30,000             667      20,010,000  0.25 (15 minutes).........................       5,002,500
 801.110.
Processing, labeling, or repacking; non-                 453              34          15,402  4.........................................          61,608
 sterile devices; 801.150(e).
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                                             Part 801, subpart H: Special Requirements for Specific Devices
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Labeling of articles intended for lay use in              35               1              35  4.........................................             140
 the repairing and/or refitting of dentures;
 801.405(b)(1).
Dentures; information regarding temporary                 35               1              35  4.........................................             140
 and emergency use; 801.405(c).
Hearing aids professional and patient                    136              12           1,632  80........................................         130,560
 labeling; 801.420.
Hearing aids, availability of User                    10,000               5          50,000  0.17 (10 minutes).........................           8,500
 Instructional Brochure; 801.421.
User labeling for menstrual tampons; 801.430              16               8             128  2.........................................             256
User labeling for latex condoms; 801.437....              52               6             312  100.......................................          31,200
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                              Part 809 (in vitro diagnostic products for human use) and Part 1040 (light-emitting products)
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Format and content of labeling for IVDs;               1,700               6          10,200  80........................................         816,000
 809.10.
Advertising and promotional materials for                300              25           7,500  1.........................................           7,500
 ASRs; 809.30(d).
Labeling of sunlamp products--1040.20(d)....              30               1              30  10........................................             300
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                                                               FD&C Action Section 502(u)
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Establishments listing <10 SUDs.............             161               2             322  0.1 (6 minutes)...........................              32
Establishments listing >10 SUDs.............              14              45             630  0.1 (6 minutes)...........................              63
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   Part 660, subparts A, C, D, E, and F: Antibody to Hepatitis B Surface Antigen; Blood Grouping Reagent; Reagent Red Blood Cells; Hepatitis B Surface
                      Antigen; Anti-Human Globulin; Part 801 subpart A: General Labeling Provisions; Part 809, subpart B: Labeling
--------------------------------------------------------------------------------------------------------------------------------------------------------
Symbols glossary--660.2; antibody to                   3,000               1           3,000  4.........................................          12,000
 Hepatitis B surface antigen requirements,
 660.28; blood grouping labeling, 660.35;
 reagent red blood cell labeling, 660.45,
 hepatitis B surface antigen labeling,
 660.55; anti-human globulin labeling,
 801.15; medical devices labeling and use of
 symbols; 809.10, labeling for in vitro
 diagnostic products.
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............      20,447,205  ..........................................       8,485,061
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Numbers have been rounded.

    Because many labeling provisions correspond to specific 
recordkeeping requirements, we have accounted for burden attendant to 
the provisions enumerated in table 3 as third-party disclosures. These 
figures reflect what we believe to be the average burden incurred by 
respondents to applicable information collection activities.
    Overall, the information collection reflects changes and 
adjustments. For efficiency of operations, we have consolidated related 
information collection previously approved under OMB control numbers 
0910-0577 and 0910-0740. This results in an increase to the information 
collection by 15,095 burden hours annually (for reporting and 
disclosure burden related to the symbols glossary regulatory 
requirements and disclosure burden related to Section 502(u)). We have 
increased our estimate of the total responses by 21,647,170 annually. 
The increase is due to adjustments reflecting updated data and the 
inclusion of the consolidated information collection. At the same time, 
we have reduced our estimate of disclosure responses by 1,597,520 
annually. Upon review, we believe we previously double-counted burden 
ascribed to disclosures provisions having accounted for the same burden 
as that associated with recordkeeping activities. Finally, upon 
submission of the ICR, we are correcting inadvertent calculation errors 
to the burden hour increase (by adding 12,000 burden hours to account 
for disclosure of the symbols glossary) and decrease in total responses 
displayed in our 60-day notice in the Federal Register of July 13, 
2021.

    Dated: October 4, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-22043 Filed 10-7-21; 8:45 am]
BILLING CODE 4164-01-P