Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Labeling Regulations, 7728-7732 [2018-03608]
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Federal Register / Vol. 83, No. 36 / Thursday, February 22, 2018 / Notices
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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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.
FOR FURTHER INFORMATION CONTACT:
Moon Hee V. Choi, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, Fax: 301–847–8533, email:
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AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory
committee meeting link, or call the
advisory committee information line to
learn about possible modifications
before coming to the meeting.
SUPPLEMENTARY INFORMATION:
Agenda: The committee will discuss
new drug application (NDA) 210365,
cannabidiol oral solution, sponsored by
GW Pharmaceuticals, for the adjunctive
treatment of seizures associated with
Lennox-Gastaut syndrome or Dravet
syndrome in patients 2 years of age and
older.
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AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
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Procedure: Interested persons may
present data, information, or views,
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orally or in writing, on issues pending
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FDA welcomes the attendance of the
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If you require accommodations due to a
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Choi (see FOR FURTHER INFORMATION
CONTACT) at least 7 days in advance of
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Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: February 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–03603 Filed 2–21–18; 8:45 am]
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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,
HHS.
ACTION:
Notice.
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,
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 Medical Device
Labeling Regulations.
DATES: Submit either electronic or
written comments on the collection of
information by April 23, 2018.
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 April 23,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of April 23, 2018. 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.
SUMMARY:
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
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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.
• 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
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‘‘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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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.
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. 3501–3520), 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
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respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Medical Device Labeling Regulations—
21 CFR parts 800, 801, and 809
OMB Control Number 0910–0485—
Extension
Section 502 of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
352), among other things, establishes
requirements for the label or labeling of
a medical device so that it is not
misbranded and subject to a regulatory
action. Certain provisions under section
502 of the FD&C Act require
manufacturers, importers, and
distributors of medical devices to
disclose information about themselves
or the devices on the labels or labeling
for the devices.
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.
FDA regulations under parts 800, 801,
and 809 (21 CFR parts 800, 801, and
809) require disclosure of specific
information by manufacturers,
importers, and distributors of medical
devices about themselves or the devices,
on the label or labeling for the devices,
to health professionals and consumers.
Most of the regulations under parts 800,
801, and 809 are derived from
requirements of section 502 of the FD&C
Act. 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.
Recordkeeping Burden
Section 801.150(a)(2) establishes
recordkeeping requirements for
manufacturers of devices 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) also requires that the
subject respondents make copies of this
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agreement available for inspection at
any reasonable hour to any officer or
employee of the Department of Health
and Human Services (HHS) who
requests them.
Section 801.410(e) requires copies of
invoices, shipping documents, and
records of sale or distribution of all
impact resistant lenses, including
finished eyeglasses and sunglasses, 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.
Section 801.421(d) establishes
requirements for hearing aid dispensers
to retain copies of all physician
statements or any waivers of medical
evaluation for 3 years after dispensing
the hearing aid.
Section 801.430(f) requires
manufacturers of menstrual tampons to
devise and follow an ongoing sampling
plan for measuring the absorbency of
menstrual tampons. In addition,
manufacturers must use the method and
testing parameters described in
§ 801.430(f).
Section 801.435(g) requires latex
condom manufacturers to document and
provide, upon request, an appropriate
justification for the application of the
testing data from one product on any
variation of that product to support
expiration dating in the user labeling.
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Third-Party Disclosure Burden
Sections 800.10(a)(3) and 800.12(c)
require that the label for contact lens
cleaning solutions bear a prominent
statement alerting consumers of the
tamper-resistant feature. Further,
§ 800.12 requires that packaged contact
lens cleaning solutions contain a
tamper-resistant feature to prevent
malicious adulteration.
Section 800.10(b)(2) requires that the
labeling for liquid ophthalmic
preparations packed in multiple-dose
containers provide information on the
duration of use and the necessary
warning information to afford adequate
protection from contamination during
use.
Section 801.1 requires that the label
for a device in package form contain the
name and place of business of the
manufacturer, packer, or distributor.
Section 801.5 requires that labeling
for a device include information on
intended use as defined under § 801.4
and provide adequate directions to
assure safe use by the lay consumers.
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Section 801.61 requires that the
principal display panel of an over-thecounter (OTC) device in package form
must bear a statement of the identity of
the device. The statement of identity of
the device must include the common
name of the device followed by an
accurate statement of the principal
intended actions of the device. Section
801.62 requires that the label for an OTC
device in package form shall bear a
declaration of the net quantity of
contents. The label must express the net
quantity in terms of weight, measure,
numerical count, or a combination of
numerical count and weight, measure,
or size.
Section 801.109 establishes labeling
requirements for prescription devices,
in which the label for the device must
describe the application or use of the
device and contain a cautionary
statement restricting the device for sale
by, or on the order of, an appropriate
professional.
Section 801.110 establishes labeling
requirements for a prescription device
delivered to the ultimate purchaser or
user, by a licensed practitioner. The
device must be accompanied by labeling
bearing the name and address of the
licensed practitioner, directions for use,
and cautionary statements, if any,
provided by the order.
Section 801.150(e) requires a written
agreement between firms involved in
the assembling or packaging of a
nonsterile device containing labeling
that identifies the final finished device
as sterile and then shipping such device
in interstate commerce prior to
sterilization. In addition, § 801.150(e)
requires that each pallet, carton, or other
designated unit be conspicuously
marked to show its nonsterile nature
when introduced into interstate
commerce and while being held prior to
sterilization. When both requirements
are met, FDA will take no regulatory
action against the device as being
misbranded or adulterated.
Section 801.405(b)(1) provides for
labeling requirements for articles,
including repair kits, re-liners, pads,
and cushions, intended for use in
temporary repairs and refitting of
dentures for lay persons. Section
801.405(b)(1) also requires that the
labeling contain the word ‘‘emergency’’
preceding and modifying each
indication-for-use statement for denture
repair kits, and the word ‘‘temporary’’
preceding and modifying each
indication-for-use statement for reliners, pads, and cushions.
Section 801.405(c) provides for
labeling requirements that contain
essentially the same information
described under § 801.405(b)(1). The
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information is intended to enable a lay
person to understand the limitations of
using OTC denture repair kits and
denture re-liners, pads, and cushions.
Section 801.420(c)(1) requires that
manufacturers or distributors of hearing
aids develop a user instructional
brochure to be provided by the
dispenser of the hearing aid to
prospective users. The brochure must
contain detailed information on the use
and maintenance of the hearing aid.
Section 801.420(c)(4) establishes
requirements that the user instructional
brochure or separate labeling provide
for technical data elements useful for
selecting, fitting, and checking the
performance of a hearing aid. In
addition, § 801.420(c)(4) provides for
testing requirements to determine that
the required data elements must be
conducted in accordance with the
American National Standards Institute
(ANSI) ‘‘Specification of Hearing Aid
Characteristics,’’ ANSI S3.22–2003
(Revision of ANSI S3.22–1996), which
is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1
CFR part 51.
Section 801.421(b) establishes
requirements for the hearing aid
dispenser to provide prospective users
with a copy of the user instructional
brochure along with an opportunity to
review content, either orally or by the
predominant method of communication
used during the sale.
Section 801.421(c) establishes
requirements for the hearing aid
dispenser to provide a copy of the user
instructional brochure to the
prospective purchaser of any hearing
aid upon request, or, if the brochure is
unavailable, provide the name and
address of the manufacturer or
distributor from which it may be
obtained.
Section 801.430(d) establishes
labeling requirements for menstrual
tampons to provide information on
signs, risk factors, and ways to reduce
the risk of Toxic Shock Syndrome
(TSS).
Section 801.430(e)(2) requires
menstrual tampon package labels to
provide information on the ranges of
absorbency and absorbency term based
on testing required under § 801.430(f)
and an explanation of selecting
absorbencies that reduce the risk of
contracting TSS.
Section 801.435(b), (c), and (h)
establishes requirements for condom
labeling to bear an expiration date that
is supported by testing that
demonstrates the integrity of three
random lots of the product.
Section 809.10(a) and (b) establishes
requirements that a label for an in vitro
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diagnostic (IVD) device and the
accompanying labeling (package insert)
must contain information identifying its
intended use, instructions for use, lot or
control number, and source.
Section 809.10(d) provides that the
labeling requirements for general
purpose laboratory reagents may be
exempt from the requirements of
§ 809.10(a) and (b) if the labeling
contains information to include,
identifying its intended use,
instructions for use, lot or control
number, and source.
Section 809.10(e) provides that the
labeling for ‘‘Analyte Specific Reagents’’
(ASRs) shall provide information to
include, identifying the quantity,
proportion, or concentration of each
reagent ingredient, instructions for use,
lot or control number, and source.
Section 809.10(f) provides that the
labeling for OTC test sample collection
systems for drugs of abuse shall include,
among other things, information on the
intended use, specimen collection
instructions, identification system, and
information about use of the test results.
Section 809.30(d) requires that
advertising and promotional materials
for ASRs include the identity and purity
of the ASR and the identity of the
analyte.
Section 1040.20(d) (21 CFR 1040.20)
provides that manufacturers of sunlamp
products and ultraviolet lamps are
subject to the labeling regulations under
part 801.
The burden estimates are based on
FDA’s current registration and listing
data and shipment information.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Activity/21 CFR section
Processing, labeling, or repacking
agreement—801.150(a)(2).
Impact resistant lenses; invoices,
shipping documents, and records
of sale or distribution—801.410(e)
and (f).
Hearing aid records—801.421(d) ....
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
Total annual
records
Average burden per
recordkeeping
Total hours
6,331
887
5,615,597
.5 (30 minutes) ..........
1,119
47,050
52,648,950
10,000
16
160
11
1,600,000
176
.25 (15 minutes) ........
80 ..............................
400,000
14,080
51
3.65
186
1 ................................
186
........................
........................
........................
....................................
3,264,184
0.0008 (.05 minutes)
2,807,799
42,119
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
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Activity/21 CFR section
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 identify—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).
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).
Labeling
requirements
for
hearing
aids—
801.420(c)(1).
Technical Data for hearing aids—801.420(c)(4) .....
Hearing aids, opportunity to review User Instructional Brochure—801.421(b).
Hearing aids, availability of User Instructional Brochure—801.421(c).
User labeling for menstrual tampons—801.430(d) ..
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Number of
disclosures
per
respondent
Total annual
disclosures
Average burden per
disclosure
Total hours
25
8
200
1 ................................
200
25
8
200
1 ................................
200
18,137
7
126,959
1 ................................
126,959
8,526
8,526
8,526
9,681
30,000
453
6
6
6
6
667
34
51,156
51,156
51,156
58,086
20,010,000
15,402
22.35 .........................
1 ................................
1 ................................
17.77 .........................
.25 (15 minutes) ........
4 ................................
1,143,337
51,156
51,156
1,032,188
5,002,500
61,608
35
1
35
4 ................................
140
35
1
35
4 ................................
140
124
12
1,488
40 ..............................
59,520
124
10,000
12
160
1,488
1,600,000
80 ..............................
.30 (20 minutes) ........
119,040
480,000
10,000
5
50,000
.17 (10 minutes) ........
8,500
16
8
128
2 ................................
256
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TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Menstrual tampons, ranges of absorbency—
801.430(e)(2).
User labeling for latex condoms—801.435(b), (c),
and (h).
Labeling for IVDs—809.10(a) and (b) .....................
Labeling for general purpose laboratory reagents—
809.10(d)(1).
Labeling for analyte specific reagents—809.10(e) ..
Labeling for OTC test sample collection systems
for drugs of abuse testing—809.10(f).
Advertising and promotional materials for ASRs—
809.30(d).
Labeling of sunlamp products—1040.20(d) .............
Total ..................................................................
1 There
Dated: February 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–03608 Filed 2–21–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2015–E–4674, FDA–
2015–E–4696, FDA–2015–E–4700, FDA–
2015–E–4703, and FDA–2015–E–4704]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; ESBRIET
Food and Drug Administration,
HHS.
ACTION:
Average burden per
disclosure
Total hours
16
8
128
2 ................................
256
51
6
306
100 ............................
30,600
1,700
300
6
2
10,200
600
80 ..............................
40 ..............................
816,000
24,000
300
20
25
1
7,500
20
1 ................................
100 ............................
7,500
2,000
300
25
7,500
1 ................................
7,500
19
1
19
10 ..............................
190
........................
........................
........................
....................................
9,024,946
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for ESBRIET and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of applications to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human drug
product.
Anyone with knowledge that any
of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are
DATES:
VerDate Sep<11>2014
20:10 Feb 21, 2018
incorrect may submit either electronic
or written comments and ask for a
redetermination by April 23, 2018.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
August 21, 2018. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
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 April 23,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of April 23, 2018. 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
Notice.
SUMMARY:
daltland on DSKBBV9HB2PROD with NOTICES
Total annual
disclosures
are no capital costs or operating and maintenance costs associated with this collection of information.
The number of recordkeepers/
respondents and records/disclosures has
been adjusted to reflect updated Agency
data. These adjustments result in an
increase of 1,598,48 hours since the last
OMB approval.
AGENCY:
Number of
disclosures
per
respondent
Number of
respondents
Activity/21 CFR section
Jkt 244001
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
PO 00000
Frm 00079
Fmt 4703
Sfmt 4703
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 Nos. FDA–
2015–E–4674, FDA–2015–E–4696,
FDA–2015–E–4700, FDA–2015–E–4703,
and FDA–2015–E–4704 for
‘‘Determination of Regulatory Review
Period for Purposes of Patent Extension;
ESBRIET.’’ Received comments, those
filed in a timely manner (see
ADDRESSES), will be placed in the
dockets 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.
E:\FR\FM\22FEN1.SGM
22FEN1
]]>Agencies
[Federal Register Volume 83, Number 36 (Thursday, February 22, 2018)]
[Notices]
[Pages 7728-7732]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03608]
-----------------------------------------------------------------------
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, 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, 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 Medical Device Labeling Regulations.
DATES: Submit either electronic or written comments on the collection
of information by April 23, 2018.
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 April 23, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 23, 2018. 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
[[Page 7729]]
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.
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.gpo.gov/fdsys/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.
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. 3501-3520), 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.
Medical Device Labeling Regulations--21 CFR parts 800, 801, and 809
OMB Control Number 0910-0485--Extension
Section 502 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 352), among other things, establishes requirements for the
label or labeling of a medical device so that it is not misbranded and
subject to a regulatory action. Certain provisions under section 502 of
the FD&C Act require manufacturers, importers, and distributors of
medical devices to disclose information about themselves or the devices
on the labels or labeling for the devices.
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.
FDA regulations under parts 800, 801, and 809 (21 CFR parts 800,
801, and 809) require disclosure of specific information by
manufacturers, importers, and distributors of medical devices about
themselves or the devices, on the label or labeling for the devices, to
health professionals and consumers. Most of the regulations under parts
800, 801, and 809 are derived from requirements of section 502 of the
FD&C Act. 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.
Recordkeeping Burden
Section 801.150(a)(2) establishes recordkeeping requirements for
manufacturers of devices 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) also requires that the subject respondents make
copies of this
[[Page 7730]]
agreement available for inspection at any reasonable hour to any
officer or employee of the Department of Health and Human Services
(HHS) who requests them.
Section 801.410(e) requires copies of invoices, shipping documents,
and records of sale or distribution of all impact resistant lenses,
including finished eyeglasses and sunglasses, 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.
Section 801.421(d) establishes requirements for hearing aid
dispensers to retain copies of all physician statements or any waivers
of medical evaluation for 3 years after dispensing the hearing aid.
Section 801.430(f) requires manufacturers of menstrual tampons to
devise and follow an ongoing sampling plan for measuring the absorbency
of menstrual tampons. In addition, manufacturers must use the method
and testing parameters described in Sec. 801.430(f).
Section 801.435(g) requires latex condom manufacturers to document
and provide, upon request, an appropriate justification for the
application of the testing data from one product on any variation of
that product to support expiration dating in the user labeling.
Third-Party Disclosure Burden
Sections 800.10(a)(3) and 800.12(c) require that the label for
contact lens cleaning solutions bear a prominent statement alerting
consumers of the tamper-resistant feature. Further, Sec. 800.12
requires that packaged contact lens cleaning solutions contain a
tamper-resistant feature to prevent malicious adulteration.
Section 800.10(b)(2) requires that the labeling for liquid
ophthalmic preparations packed in multiple-dose containers provide
information on the duration of use and the necessary warning
information to afford adequate protection from contamination during
use.
Section 801.1 requires that the label for a device in package form
contain the name and place of business of the manufacturer, packer, or
distributor.
Section 801.5 requires that labeling for a device include
information on intended use as defined under Sec. 801.4 and provide
adequate directions to assure safe use by the lay consumers.
Section 801.61 requires that the principal display panel of an
over-the-counter (OTC) device in package form must bear a statement of
the identity of the device. The statement of identity of the device
must include the common name of the device followed by an accurate
statement of the principal intended actions of the device. Section
801.62 requires that the label for an OTC device in package form shall
bear a declaration of the net quantity of contents. The label must
express the net quantity in terms of weight, measure, numerical count,
or a combination of numerical count and weight, measure, or size.
Section 801.109 establishes labeling requirements for prescription
devices, in which the label for the device must describe the
application or use of the device and contain a cautionary statement
restricting the device for sale by, or on the order of, an appropriate
professional.
Section 801.110 establishes labeling requirements for a
prescription device delivered to the ultimate purchaser or user, by a
licensed practitioner. The device must be accompanied by labeling
bearing the name and address of the licensed practitioner, directions
for use, and cautionary statements, if any, provided by the order.
Section 801.150(e) requires a written agreement between firms
involved in the assembling or packaging of a nonsterile device
containing labeling that identifies the final finished device as
sterile and then shipping such device in interstate commerce prior to
sterilization. In addition, Sec. 801.150(e) requires that each pallet,
carton, or other designated unit be conspicuously marked to show its
nonsterile nature when introduced into interstate commerce and while
being held prior to sterilization. When both requirements are met, FDA
will take no regulatory action against the device as being misbranded
or adulterated.
Section 801.405(b)(1) provides for labeling requirements for
articles, including repair kits, re-liners, pads, and cushions,
intended for use in temporary repairs and refitting of dentures for lay
persons. Section 801.405(b)(1) also requires that the labeling contain
the word ``emergency'' preceding and modifying each indication-for-use
statement for denture repair kits, and the word ``temporary'' preceding
and modifying each indication-for-use statement for re-liners, pads,
and cushions.
Section 801.405(c) provides for labeling requirements that contain
essentially the same information described under Sec. 801.405(b)(1).
The information is intended to enable a lay person to understand the
limitations of using OTC denture repair kits and denture re-liners,
pads, and cushions.
Section 801.420(c)(1) requires that manufacturers or distributors
of hearing aids develop a user instructional brochure to be provided by
the dispenser of the hearing aid to prospective users. The brochure
must contain detailed information on the use and maintenance of the
hearing aid.
Section 801.420(c)(4) establishes requirements that the user
instructional brochure or separate labeling provide for technical data
elements useful for selecting, fitting, and checking the performance of
a hearing aid. In addition, Sec. 801.420(c)(4) provides for testing
requirements to determine that the required data elements must be
conducted in accordance with the American National Standards Institute
(ANSI) ``Specification of Hearing Aid Characteristics,'' ANSI S3.22-
2003 (Revision of ANSI S3.22-1996), which is incorporated by reference
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
Section 801.421(b) establishes requirements for the hearing aid
dispenser to provide prospective users with a copy of the user
instructional brochure along with an opportunity to review content,
either orally or by the predominant method of communication used during
the sale.
Section 801.421(c) establishes requirements for the hearing aid
dispenser to provide a copy of the user instructional brochure to the
prospective purchaser of any hearing aid upon request, or, if the
brochure is unavailable, provide the name and address of the
manufacturer or distributor from which it may be obtained.
Section 801.430(d) establishes labeling requirements for menstrual
tampons to provide information on signs, risk factors, and ways to
reduce the risk of Toxic Shock Syndrome (TSS).
Section 801.430(e)(2) requires menstrual tampon package labels to
provide information on the ranges of absorbency and absorbency term
based on testing required under Sec. 801.430(f) and an explanation of
selecting absorbencies that reduce the risk of contracting TSS.
Section 801.435(b), (c), and (h) establishes requirements for
condom labeling to bear an expiration date that is supported by testing
that demonstrates the integrity of three random lots of the product.
Section 809.10(a) and (b) establishes requirements that a label for
an in vitro
[[Page 7731]]
diagnostic (IVD) device and the accompanying labeling (package insert)
must contain information identifying its intended use, instructions for
use, lot or control number, and source.
Section 809.10(d) provides that the labeling requirements for
general purpose laboratory reagents may be exempt from the requirements
of Sec. 809.10(a) and (b) if the labeling contains information to
include, identifying its intended use, instructions for use, lot or
control number, and source.
Section 809.10(e) provides that the labeling for ``Analyte Specific
Reagents'' (ASRs) shall provide information to include, identifying the
quantity, proportion, or concentration of each reagent ingredient,
instructions for use, lot or control number, and source.
Section 809.10(f) provides that the labeling for OTC test sample
collection systems for drugs of abuse shall include, among other
things, information on the intended use, specimen collection
instructions, identification system, and information about use of the
test results.
Section 809.30(d) requires that advertising and promotional
materials for ASRs include the identity and purity of the ASR and the
identity of the analyte.
Section 1040.20(d) (21 CFR 1040.20) provides that manufacturers of
sunlamp products and ultraviolet lamps are subject to the labeling
regulations under part 801.
The burden estimates are based on FDA's current registration and
listing data and shipment information.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity/21 CFR section Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Processing, labeling, or repacking 6,331 887 5,615,597 .5 (30 minutes).................... 2,807,799
agreement--801.150(a)(2).
Impact resistant lenses; invoices, 1,119 47,050 52,648,950 0.0008 (.05 minutes)............... 42,119
shipping documents, and records of
sale or distribution--801.410(e) and
(f).
Hearing aid records--801.421(d)....... 10,000 160 1,600,000 .25 (15 minutes)................... 400,000
Menstrual tampons, sampling plan for 16 11 176 80................................. 14,080
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............................. .............. .............. .............. ................................... 3,264,184
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Number of disclosures Total annual
Activity/21 CFR section respondents per disclosures Average burden per disclosure Total hours
respondent
--------------------------------------------------------------------------------------------------------------------------------------------------------
Contact lens cleaning solution labeling-- 25 8 200 1......................................... 200
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 18,137 7 126,959 1......................................... 126,959
information--801.1.
Adequate directions for use--801.5.......... 8,526 6 51,156 22.35..................................... 1,143,337
Statement of identify--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..................................... 1,032,188
Retail exemption for prescription devices-- 30,000 667 20,010,000 .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).
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).
Labeling requirements for hearing aids-- 124 12 1,488 40........................................ 59,520
801.420(c)(1).
Technical Data for hearing aids-- 124 12 1,488 80........................................ 119,040
801.420(c)(4).
Hearing aids, opportunity to review User 10,000 160 1,600,000 .30 (20 minutes).......................... 480,000
Instructional Brochure--801.421(b).
Hearing aids, availability of User 10,000 5 50,000 .17 (10 minutes).......................... 8,500
Instructional Brochure--801.421(c).
User labeling for menstrual tampons-- 16 8 128 2......................................... 256
801.430(d).
[[Page 7732]]
Menstrual tampons, ranges of absorbency-- 16 8 128 2......................................... 256
801.430(e)(2).
User labeling for latex condoms--801.435(b), 51 6 306 100....................................... 30,600
(c), and (h).
Labeling for IVDs--809.10(a) and (b)........ 1,700 6 10,200 80........................................ 816,000
Labeling for general purpose laboratory 300 2 600 40........................................ 24,000
reagents--809.10(d)(1).
Labeling for analyte specific reagents-- 300 25 7,500 1......................................... 7,500
809.10(e).
Labeling for OTC test sample collection 20 1 20 100....................................... 2,000
systems for drugs of abuse testing--
809.10(f).
Advertising and promotional materials for 300 25 7,500 1......................................... 7,500
ASRs--809.30(d).
Labeling of sunlamp products--1040.20(d).... 19 1 19 10........................................ 190
-----------------------------------------------------------------------------------------------------------
Total................................... .............. .............. .............. .......................................... 9,024,946
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The number of recordkeepers/respondents and records/disclosures has
been adjusted to reflect updated Agency data. These adjustments result
in an increase of 1,598,48 hours since the last OMB approval.
Dated: February 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03608 Filed 2-21-18; 8:45 am]
BILLING CODE 4164-01-P
