Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Labeling Regulations, 44884-44887 [2018-19086]
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Federal Register / Vol. 83, No. 171 / Tuesday, September 4, 2018 / Notices
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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of this guidance to the Division
of Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Xinyuan Zhang, Office of Clinical
Pharmacology, Office of Translational
Sciences, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 2128, Silver Spring,
MD 20993–0002, 240–402–7971.
SUPPLEMENTARY INFORMATION:
sradovich on DSK3GMQ082PROD with NOTICES
I. Background
FDA is announcing the availability of
a final guidance for industry entitled
‘‘Physiologically Based Pharmacokinetic
Analyses—Format and Content.’’ A
PBPK analysis uses models and
simulations that combine physiology,
population, and drug characteristics to
mechanistically describe the
pharmacokinetic behaviors of a drug or
drug product. Throughout a drug’s life
cycle, PBPK model predictions can be
used to support decisions on whether,
when, and how to conduct certain
clinical pharmacology studies, and to
support dosing recommendations in
product labeling. Because of the lack of
regulatory guidance, the format and
content of PBPK analysis reports that
are submitted to FDA vary significantly.
The goal of this guidance is to
standardize the content and format of
these reports to facilitate FDA’s efficient
assessment, consistent application, and
timely decision making during
regulatory review.
This guidance outlines the
recommended format and content for a
sponsor or applicant to submit PBPK
analyses to FDA to support applications
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including, but not limited to, INDs,
NDAs, BLAs, and ANDAs. This
guidance does not address
methodological considerations and best
practices for the conduct of PBPK
modeling and simulation or the
appropriateness of PBPK analyses for a
particular drug or a drug product.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Physiologically
Based Pharmacokinetic Analyses—
Format and Content.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations. This
guidance is not subject to Executive
Order 12866.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collection of information in
21 CFR 314.50(d) has been approved
under OMB control number 0910–0001.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: August 27, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–19065 Filed 8–31–18; 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; Submission for Office of
Management and Budget Review;
Comment Request; Medical Device
Labeling Regulations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
SUMMARY:
PO 00000
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Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by October 4,
2018.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0485. Also
include the FDA docket number found
in brackets in the heading of this
document.
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: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Medical Device Labeling Regulations—
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
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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.
sradovich on DSK3GMQ082PROD with NOTICES
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
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.
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
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44885
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
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
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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
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.
In the Federal Register of February
22, 2018 (83 FR 7728), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. FDA received one
comment regarding environmental
concerns. We believe this issue is
beyond the scope of this information
request.
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) ............
2,807,799
1,119
47,050
52,648,950
0.0008 (.05 minutes) ...
42,119
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
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
sradovich on DSK3GMQ082PROD with NOTICES
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).
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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
6
6
6
6
667
51,156
51,156
51,156
58,086
20,010,000
22.35 ...........................
1 ..................................
1 ..................................
17.77 ...........................
.25 (15 minutes) ..........
1,143,337
51,156
51,156
1,032,188
5,002,500
453
34
15,402
4 ..................................
61,608
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Federal Register / Vol. 83, No. 171 / Tuesday, September 4, 2018 / Notices
44887
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Number of
respondents
Activity/21 CFR section
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)
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 ASRs—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: August 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–19086 Filed 8–31–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3091]
Advisory Committee; Cardiovascular
and Renal Drugs Advisory Committee;
Renewal
Food and Drug Administration,
HHS.
sradovich on DSK3GMQ082PROD with NOTICES
Total
annual
disclosures
Average
burden per
disclosure
Total
hours
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
8,500
16
16
8
8
128
128
.17 ...............................
(10 minutes) ................
2 ..................................
2 ..................................
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
256
256
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
Notice; renewal of advisory
committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Cardiovascular and Renal
Drugs Advisory Committee by the
Commissioner of Food and Drugs (the
Commissioner). The Commissioner has
SUMMARY:
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17:54 Aug 31, 2018
Jkt 244001
determined that it is in the public
interest to renew the Cardiovascular and
Renal Drugs Advisory Committee for an
additional 2 years beyond the charter
expiration date. The new charter will be
in effect until August 27, 2020.
DATES: Authority for the Cardiovascular
and Renal Drugs Advisory Committee
will expire on August 27, 2020, unless
the Commissioner formally determines
that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT:
Jennifer Shepherd, 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, email: CRDAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services pursuant to 45 CFR part 11 and
by the General Services Administration,
FDA is announcing the renewal of the
Cardiovascular and Renal Drugs
Advisory Committee. The committee is
a discretionary Federal advisory
committee established to provide advice
to the Commissioner.
The Cardiovascular and Renal Drugs
Advisory Committee advises the
Commissioner or designee in
discharging responsibilities as they
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Sfmt 4703
relate to helping to ensure safe and
effective drugs for human use and, as
required, any other product for which
FDA has regulatory responsibility.
The committee reviews and evaluates
available data concerning the safety and
effectiveness of marketed and
investigational human drug products for
use in the treatment of cardiovascular
and renal disorders and makes
appropriate recommendations to the
Commissioner.
The committee shall consist of a core
of 11 voting members including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of
cardiology, hypertension, arrhythmia,
angina, congestive heart failure,
diuresis, and biostatistics. Members will
be invited to serve for overlapping terms
of up to 4 years. Almost all non-Federal
members of this committee serve as
Special Government Employees. The
core of voting members may include one
technically qualified member, selected
by the Commissioner or designee, who
is identified with consumer interests
and is recommended by either a
consortium of consumer-oriented
organizations or other interested
persons. In addition to the voting
members, the committee may include
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]]>Agencies
[Federal Register Volume 83, Number 171 (Tuesday, September 4, 2018)]
[Notices]
[Pages 44884-44887]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19086]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1048]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Device
Labeling Regulations
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by October
4, 2018.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0485.
Also include the FDA docket number found in brackets in the heading of
this document.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Medical Device Labeling Regulations--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
[[Page 44885]]
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 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
[[Page 44886]]
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 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.
In the Federal Register of February 22, 2018 (83 FR 7728), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received one comment regarding
environmental concerns. We believe this issue is beyond the scope of
this information request.
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, shipping 1,119 47,050 52,648,950 0.0008 (.05 minutes)....................... 42,119
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).
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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).
[[Page 44887]]
Labeling of articles intended for lay use 35 1 35 4.......................................... 140
in 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........................................ 8,500
Instructional Brochure--801.421(c). (10 minutes)...............................
User labeling for menstrual tampons-- 16 8 128 2.......................................... 256
801.430(d).
Menstrual tampons, ranges of absorbency-- 16 8 128 2.......................................... 256
801.430(e)(2).
User labeling for latex condoms-- 51 6 306 100........................................ 30,600
801.435(b), (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 ASRs--809.10(e)............... 300 25 7,500 1.......................................... 7,500
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: August 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19086 Filed 8-31-18; 8:45 am]
BILLING CODE 4164-01-P
