Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Labeling Regulations, 36752-36756 [2021-14768]
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Federal Register / Vol. 86, No. 131 / Tuesday, July 13, 2021 / Notices
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and Budget (OMB) for each collection of
information they conduct or sponsor.
The term ‘‘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. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
Information Collection
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Statement of
Deficiency and Plan of Correction Use:
The form CMS–2567 is the means by
which State and CMS surveyors
document findings of compliance or
noncompliance (deficiencies) resulting
from inspection of Medicare, Medicaid,
and Clinical Laboratory Improvement
Amendments (CLIA) laboratories. The
form CMS–2567 is the legal,
documentary basis for CMS’
certification of a facility’s compliance or
noncompliance with the Medicare/
Medicaid Conditions of Participation or
Coverage, and the requirements for
Nursing Home participation and CLIA
certification.
In December, 2020, Congress passed
the Consolidated Appropriations Act,
2021 (CAA, 2021). Section 407 of CAA,
2021, amended Part A of Title XVIII of
the Social Security Act (the Act) at
section 1822 establishing hospice
program survey and enforcement
requirements. This amendment, in part,
now requires the Accrediting
Organizations (AOs) that accredit
hospice programs to include the form
CMS–2567 to document the findings of
their hospice program surveys
beginning on October 1, 2021. As of
June 2021, there are three AOs with
CMS-approved hospice accreditation
programs. The AOs survey
approximately half of the over 5,000
Medicare-certified hospice programs,
while the SAs survey the remaining
half.
To enable AOs to use the form CMS–
2567, we must revise it by adding fields
for the AO name. Also, the instructions
must be updated to include AOs as
another group which utilizes the form
CMS–2567. We have also included the
burden calculations from CMS–1747–P
(Medicare and Medicaid Programs; CY
2022 Home Health Prospective Payment
System Rate Update), related to the onetime update needed to each of AO’s
proprietary electronic systems in order
to use the form CMS–2567 as directed
by the CAA, 2021. Form Numbers:
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CMS–2567 (OMB control number:
0938–0391); Frequency: Yearly and
Occasionally; Affected Public: Private
Sector (Business or for-profits and Notfor-profit institutions); Number of
Respondents: 65,948; Total Annual
Responses: 65,948; Total Annual Hours:
1,210,376. (For policy questions
regarding this collection contact
Caroline Gallaher at 410–786–8705.)
Dated: July 8, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2021–14866 Filed 7–12–21; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–0895]
Issuance of Priority Review Voucher;
Material Threat Medical
Countermeasure Product
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Food and Drug
Administration (FDA) is announcing the
issuance of a priority review voucher to
the sponsor of a material threat medical
countermeasure (MCM) product
application. The Federal Food, Drug,
and Cosmetic Act (FD&C Act), as
amended by the 21st Century Cures Act
(Cures Act), authorizes FDA to award
priority review vouchers to sponsors of
approved material threat MCM product
applications that meet certain criteria.
FDA is required to publish notice of the
award of the priority review voucher.
FDA has determined that
STRATAGRAFT (allogeneic cultured
keratinocytes and dermal fibroblasts in
murine collagen—dsat), manufactured
by Stratatech, a Mallinckrodt Company,
meets the criteria for a priority review
voucher.
FOR FURTHER INFORMATION CONTACT:
Shruti Modi, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave, Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION: FDA is
announcing the issuance of a material
threat MCM priority review voucher to
the sponsor of an approved material
threat MCM product application. Under
section 565A of the FD&C Act (21 U.S.C.
360bbb–4a), which was added by the
SUMMARY:
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Cures Act (Pub. L. 114–255), FDA will
award priority review vouchers to
sponsors of approved material threat
MCM product applications that meet
certain criteria upon approval of those
applications. FDA has determined that
STRATAGRAFT (allogeneic cultured
keratinocytes and dermal fibroblasts in
murine collagen—dsat), manufactured
by Stratatech, a Mallinckrodt Company,
meets the criteria for a material threat
MCM priority review voucher.
STRATAGRAFT is indicated for the
treatment of adults with thermal burns
containing intact dermal elements for
which surgical intervention is clinically
indicated (deep partial-thickness burns).
For further information about the
material threat MCM Priority Review
Voucher Program and for a link to the
full text of section 565A of the FD&C
Act, go to https://www.fda.gov/
emergency-preparedness-and-response/
mcm-legal-regulatory-and-policyframework/mcm-relatedcounterterrorism-legislation. For further
information about STRATAGRAFT
(allogeneic cultured keratinocytes and
dermal fibroblasts in murine collagen—
dsat), go to the Center for Biologics
Evaluation and Research Approved
Cellular and Gene Therapy Products
website at https://www.fda.gov/
vaccines-blood-biologics/cellular-genetherapy-products/approved-cellularand-gene-therapy-products.
Dated: July 6, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–14779 Filed 7–12–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1048]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Device
Labeling Regulations
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
SUMMARY:
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Federal Register / Vol. 86, No. 131 / Tuesday, July 13, 2021 / Notices
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 medical
device labeling regulations.
DATES: Submit either electronic or
written comments on the collection of
information by September 13, 2021.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before September 13,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of September 13, 2021.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
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
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://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’’).
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Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
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Staff, 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–
2014–N–1048 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Medical
Device Labeling Regulations.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• 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
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. 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: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
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 Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
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36753
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, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), 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.
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
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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 part 1040 (21 CFR parts
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.
Information collection 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.
Finally, 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.
We have revised the information
collection to include reference to
Agency guidance. The guidance
documents were developed and issued
consistent with our Good Guidance
Practice regulations in 21 CFR 10.115,
which provide for public comment at
any time.
Section 502(b) of the FD&C Act
requires that, for packaged devices, the
label 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 that the
labeling for a device must contain
adequate directions for use. FDA may,
however, grant an exemption if the
Agency determines that the adequate
directions for use labeling requirements
are not necessary for the particular case
as it relates to protection of the public
health. Section 301 of the Medical
Device User Fee and Modernization Act
of 2002 (Pub. L. 107–250) amended
section 502 of the FD&C Act to add
paragraph (u) to section 502 to require
devices (both new and reprocessed) 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.
Section 2(c) of the Medical Device
User Fee Stabilization Act of 2005
(MDUFSA) amended section 502(u) of
the FD&C Act by limiting the provision
to reprocessed single-use devices
(SUDs) and the manufacturers who
reprocess them. Under the amended
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
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. MDUFSA
required that FDA issue guidance
identifying the circumstances in which
the name, abbreviation, or symbol of the
manufacturer of an original device is not
‘‘prominent and conspicuous’’ under
section 502(u) of the FD&C Act.
Accordingly, we issued the guidance
document entitled ‘‘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), 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. We
believe the information disclosures
discussed in the guidance impose no
burden beyond that which we attribute
already to complying with disclosure
provisions found in the applicable
regulations; however, we include the
guidance document for respondents’
instructional use and reference.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses
per
respondent
Total annual
responses
Average
burden per
response
Total hours
Symbols glossary .................................................................
3,000
1
3,000
1
3,000
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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 allows the use of
stand-alone graphical representations of
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information, or symbols, in the labeling
for the medical devices, if the symbol
has been established in a Standards
Development Organization developed
standard, provided that such symbol is
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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.
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Federal Register / Vol. 86, No. 131 / Tuesday, July 13, 2021 / Notices
36755
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 2
Number of
recordkeepers
Activity
Processing, labeling, or repacking agreement;
801.150.
Impact resistant lenses; invoices, shipping documents, and records of sale or distribution;
801.410(e) and (f).
Hearing aid records; 801.421 ...............................
Menstrual tampons, sampling plan for measuring
absorbency; 801.430(f).
Latex condoms; justification for the application of
testing data to the variation of the tested product; 801.435(g).
Total ...............................................................
1 There
Number of
records per
recordkeeper
Average
burden per
recordkeeping
Total annual
records
0.5 (30 minutes) ...........
Total hours
7,500
887
6,652,500
1,591
47,050
74,856,550
10,000
33
160
11
1,600,000
363
0.25 (15 minutes) .........
80 ..................................
400,000
29,040
51
3.65
186
1 ....................................
186
........................
........................
83,109,599
.......................................
3,815,361
0.0008 (0.048 minutes)
3,326,250
59,885
are no capital costs or operating and maintenance costs associated with this collection of information.
have been rounded.
2 Numbers
As set forth in § 801.150(a)(2) (21 CFR
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
§ 801.410(e) (21 CFR 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
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 21 CFR 801.421(d), 801.430(f),
and 801.435(g), respectively.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 2
Number of
respondents
Activity
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
Parts 800; and Part 801, subparts A, C, D, and E: General Labeling; OTC Devices; Exemptions
Contact lens cleaning solution labeling; 800.10(a)(3) and
800.12(c).
Liquid ophthalmic preparation labeling; 800.10(b)(2) ..........
Manufacturer, packer, or distributor information; 801.1 ......
Adequate directions for use; 801.5 .....................................
Statement of identity; 801.61 ..............................................
Declaration of net quantity of contents; 801.62 ..................
Prescription device labeling; 801.109 .................................
Retail exemption for prescription devices; 801.110 ............
Processing, labeling, or repacking; non-sterile devices;
801.150(e).
47
8
376
1 .....................
376
25
19,407
8,526
8,526
8,526
9,681
30,000
453
8
7
6
6
6
6
667
34
200
135,849
51,156
51,156
51,156
58,086
20,010,000
15,402
1 .....................
1 .....................
22.35 ..............
1 .....................
1 .....................
17.77 ..............
0.25 ................
4 .....................
200
135,849
1,143,337
51,156
51,156
1,032,188
5,002,500
61,608
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Part 801, subpart H: Special Requirements for Specific Devices
Labeling of articles intended for lay use in the repairing
and/or refitting of dentures; 801.405(b)(1).
Dentures; information regarding temporary and emergency
use; 801.405(c).
Hearing aids professional and patient labeling; 801.420 ....
Hearing aids, availability of User Instructional Brochure;
801.421.
User labeling for menstrual tampons; 801.430 ...................
User labeling for latex condoms; 801.437 ..........................
35
1
35
4 .....................
140
35
1
35
4 .....................
140
136
10,000
12
5
1,632
50,000
80 ...................
0.17 ................
130,560
8,500
16
52
8
6
128
312
2 .....................
100 .................
256
31,200
Part 809 (in vitro diagnostic products for human use) and Part 1040 (light-emitting products)
Format and content of labeling for IVDs; 809.10 ................
Advertising and promotional materials for ASRs; 809.30(d)
Labeling of sunlamp products—1040.20(d) ........................
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1,700
300
30
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6
25
1
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10,200
7,500
30
13JYN1
80 ...................
1 .....................
10 ...................
816,000
7,500
300
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TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 2—Continued
Number of
respondents
Activity
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
FD&C Action Section 502(u)
Establishments listing <10 SUDs ........................................
Establishments listing >10 SUDs ........................................
161
14
2
45
322
630
0.1 (6 minutes)
0.1 (6 minutes)
32
63
Total ..............................................................................
........................
........................
952
........................
95
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 currently approved under
OMB control numbers 0910–0577 and
0910–0740 pertaining to
recommendations found in Agency
guidance and discussed in this notice.
This results in an increase to the
information collection by 30,482 burden
hours annually. At the same time, we
have reduced our estimate of the total
responses by 53,143,810 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. We invite
comment on our estimates and these
assumptions.
Dated: July 2, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–14768 Filed 7–12–21; 8:45 am]
jbell on DSKJLSW7X2PROD with NOTICES
BILLING CODE 4164–01–P
VerDate Sep<11>2014
17:47 Jul 12, 2021
Jkt 253001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: Advanced
Nursing Education Program Specific
Form OMB No. 0915–0375—Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than September 13,
2021.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Advanced Nursing Education (ANE)
SUMMARY:
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
Program Specific Form OMB No. 0915–
0375—Revision.
Abstract: HRSA provides advanced
nursing education grants to educational
institutions to increase the supply,
distribution, quality of, and access to
advanced education nurses through the
ANE Programs. The ANE Programs are
authorized by Section 811 of the Public
Health Service Act (42 U.S.C. 296j), as
amended. This clearance request is for
continued approval of the information
collection OMB No. 0915–0375 with
revisions.
This revision request includes a title
change from the Advanced Nursing
Education Workforce (ANEW) ProgramSpecific Data Collection Forms to ANE
Program Specific Form. This revision
also merges forms used by the ANEW
Program and adds several other new
forms from the ANE Programs,
including the Advanced Nursing
Education Nurse Practitioner Residency
(ANE–NPR) Program, Advanced
Nursing Education Nurse Practitioner
Residency Integration Program (ANE–
NPRIP), Nurse Anesthetist Traineeship
(NAT) Program, and Advanced Nursing
Education Sexual Assault Nurse
Examiners (ANE–SANE) Program. The
revision of the ANE Program Specific
Form incorporates elements from these
four programs (ANE–NPR, ANE–NPRIP,
NAT, and ANE–SANE) into the ANE
Program Specific Form.
Need and Proposed Use of the
Information: Section 811 of the Public
Health Service Act provides the
Secretary of HHS with the authority to
award grants to and enter into contracts
with eligible entities to meet the costs
of—(1) projects that support the
enhancement of advanced nursing
education and practice; and (2)
traineeships for individuals in advanced
nursing education programs. Under this
section, HRSA makes awards to entities
who train and support nurses
characterized as ‘‘advanced education
nurses.’’ In awarding such grants,
funding preference is given to
applicants with projects that will
E:\FR\FM\13JYN1.SGM
13JYN1
]]>Agencies
[Federal Register Volume 86, Number 131 (Tuesday, July 13, 2021)]
[Notices]
[Pages 36752-36756]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14768]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1048]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Device Labeling Regulations
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information,
[[Page 36753]]
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 medical device labeling regulations.
DATES: Submit either electronic or written comments on the collection
of information by September 13, 2021.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before September 13, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of September 13, 2021. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 information, or other information that identifies you in
the body of your comments, that information will be posted on https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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-2014-N-1048 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Medical Device Labeling
Regulations.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
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: Under the PRA (44 U.S.C. 3501-3521), 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.
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
[[Page 36754]]
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 part 1040 (21 CFR parts 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. Information collection 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. Finally, 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.
We have revised the information collection to include reference to
Agency guidance. The guidance documents were developed and issued
consistent with our Good Guidance Practice regulations in 21 CFR
10.115, which provide for public comment at any time.
Section 502(b) of the FD&C Act requires that, for packaged devices,
the label 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 that the labeling
for a device must contain adequate directions for use. FDA may,
however, grant an exemption if the Agency determines that the adequate
directions for use labeling requirements are not necessary for the
particular case as it relates to protection of the public health.
Section 301 of the Medical Device User Fee and Modernization Act of
2002 (Pub. L. 107-250) amended section 502 of the FD&C Act to add
paragraph (u) to section 502 to require devices (both new and
reprocessed) 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.
Section 2(c) of the Medical Device User Fee Stabilization Act of
2005 (MDUFSA) amended section 502(u) of the FD&C Act by limiting the
provision to reprocessed single-use devices (SUDs) and the
manufacturers who reprocess them. Under the amended 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 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. MDUFSA required that FDA issue
guidance identifying the circumstances in which the name, abbreviation,
or symbol of the manufacturer of an original device is not ``prominent
and conspicuous'' under section 502(u) of the FD&C Act. Accordingly, we
issued the guidance document entitled ``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), 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. We believe the
information disclosures discussed in the guidance impose no burden
beyond that which we attribute already to complying with disclosure
provisions found in the applicable regulations; however, we include the
guidance document for respondents' instructional use and reference.
We estimate 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Symbols glossary................................................... 3,000 1 3,000 1 3,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 allows the use
of stand-alone graphical representations of information, or symbols, in
the labeling for the medical devices, 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.
[[Page 36755]]
Table 2--Estimated Annual Recordkeeping Burden 1 2
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Processing, labeling, or 7,500 887 6,652,500 0.5 (30 minutes) 3,326,250
repacking agreement; 801.150.
Impact resistant lenses; 1,591 47,050 74,856,550 0.0008 (0.048 59,885
invoices, shipping documents, minutes).
and records of sale or
distribution; 801.410(e) and
(f).
Hearing aid records; 801.421.. 10,000 160 1,600,000 0.25 (15 400,000
minutes).
Menstrual tampons, sampling 33 11 363 80.............. 29,040
plan for measuring
absorbency; 801.430(f).
Latex condoms; justification 51 3.65 186 1............... 186
for the application of
testing data to the variation
of the tested product;
801.435(g).
---------------------------------------------------------------------------------
Total..................... .............. .............. 83,109,599 ................ 3,815,361
----------------------------------------------------------------------------------------------------------------
\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) (21 CFR 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) (21 CFR 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 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 21 CFR 801.421(d), 801.430(f), and
801.435(g), respectively.
Table 3--Estimated Annual Third-Party Disclosure Burden 1 2
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of disclosures Total annual Average burden per Total hours
respondents per respondent disclosures disclosure
----------------------------------------------------------------------------------------------------------------
Parts 800; and Part 801, subparts A, C, D, and E: General Labeling; OTC Devices; Exemptions
----------------------------------------------------------------------------------------------------------------
Contact lens cleaning 47 8 376 1................. 376
solution labeling;
800.10(a)(3) and 800.12(c).
Liquid ophthalmic 25 8 200 1................. 200
preparation labeling;
800.10(b)(2).
Manufacturer, packer, or 19,407 7 135,849 1................. 135,849
distributor information;
801.1.
Adequate directions for use; 8,526 6 51,156 22.35............. 1,143,337
801.5.
Statement of identity; 8,526 6 51,156 1................. 51,156
801.61.
Declaration of net quantity 8,526 6 51,156 1................. 51,156
of contents; 801.62.
Prescription device 9,681 6 58,086 17.77............. 1,032,188
labeling; 801.109.
Retail exemption for 30,000 667 20,010,000 0.25.............. 5,002,500
prescription devices;
801.110.
Processing, labeling, or 453 34 15,402 4................. 61,608
repacking; non-sterile
devices; 801.150(e).
----------------------------------------------------------------------------------------------------------------
Part 801, subpart H: Special Requirements for Specific Devices
----------------------------------------------------------------------------------------------------------------
Labeling of articles 35 1 35 4................. 140
intended for lay use in the
repairing and/or refitting
of dentures; 801.405(b)(1).
Dentures; information 35 1 35 4................. 140
regarding temporary and
emergency use; 801.405(c).
Hearing aids professional 136 12 1,632 80................ 130,560
and patient labeling;
801.420.
Hearing aids, availability 10,000 5 50,000 0.17.............. 8,500
of User Instructional
Brochure; 801.421.
User labeling for menstrual 16 8 128 2................. 256
tampons; 801.430.
User labeling for latex 52 6 312 100............... 31,200
condoms; 801.437.
----------------------------------------------------------------------------------------------------------------
Part 809 (in vitro diagnostic products for human use) and Part 1040 (light-emitting products)
----------------------------------------------------------------------------------------------------------------
Format and content of 1,700 6 10,200 80................ 816,000
labeling for IVDs; 809.10.
Advertising and promotional 300 25 7,500 1................. 7,500
materials for ASRs;
809.30(d).
Labeling of sunlamp 30 1 30 10................ 300
products--1040.20(d).
----------------------------------------------------------------------------------------------------------------
[[Page 36756]]
FD&C Action Section 502(u)
----------------------------------------------------------------------------------------------------------------
Establishments listing <10 161 2 322 0.1 (6 minutes)... 32
SUDs.
Establishments listing >10 14 45 630 0.1 (6 minutes)... 63
SUDs.
-----------------------------------------------------------------------------------
Total................... .............. .............. 952 .................. 95
----------------------------------------------------------------------------------------------------------------
\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 currently approved under OMB control numbers
0910-0577 and 0910-0740 pertaining to recommendations found in Agency
guidance and discussed in this notice. This results in an increase to
the information collection by 30,482 burden hours annually. At the same
time, we have reduced our estimate of the total responses by 53,143,810
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. We invite comment on
our estimates and these assumptions.
Dated: July 2, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-14768 Filed 7-12-21; 8:45 am]
BILLING CODE 4164-01-P
