4928 Federal Register / Vol. 80, No. 19 / Thursday, January 29, 2015 / Notices 

establish special controls, including 

performance standards, postmarket 

surveillance, patient registries, 

guidelines, and other appropriate 

actions it believes necessary to provide 

reasonable assurance of the safety and 

effectiveness of the device. The special 

control guidance serves to support the 

reclassification from class III to class II 

of the automated blood cell separator 

device operating on a centrifugal 

separation principle intended for the 

routine collection of blood and blood 

components as well as the special 

control for the automated blood cell 

separator device operating on a filtration 

separation principle intended for the 

routine collection of blood and blood 

components reclassified as class II 

(§ 864.9245 (21 CFR 864.9245)). 

For currently marketed products not 

approved under the premarket approval 

process, the manufacturer should file 

with FDA, for 3 consecutive years, an 

annual report on the anniversary date of 

the device reclassification from class III 

to class II or on the anniversary date of 

the 510(k) of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) (21 

U.S.C. 360) clearance. Any subsequent 

change to the device requiring the 

submission of a premarket notification 

in accordance with section 510(k) of the 

FD&C Act should be included in the 

annual report. Also, a manufacturer of a 

device determined to be substantially 

equivalent to the centrifugal or 

filtration-based automated cell separator 

device intended for the routine 

collection of blood and blood 

components should comply with the 

same general and special controls. 

The annual report should include, at 

a minimum, a summary of anticipated 

and unanticipated adverse events that 

have occurred and that are not required 

to be reported by manufacturers under 

Medical Device Reporting (MDR) (part 

803 (21 CFR part 803)). The reporting of 

adverse device events summarized in an 

annual report will alert FDA to trends 

or clusters of events that might be a 

safety issue otherwise unreported under 

the MDR regulation. 

Reclassification of this device from 

class III to class II for the intended use 

of routine collection of blood and blood 

components relieves manufacturers of 

the burden of complying with the 

premarket approval requirements of 

section 515 of the FD&C Act (21 U.S.C. 

360e), and may permit small potential 

competitors to enter the marketplace by 

reducing the burden. Although the 

special control guidance recommends 

that manufacturers of these devices file 

with FDA an annual report for 3 

consecutive years, this would be less 

burdensome than the current 

postapproval requirements under part 

814, subpart E (21 CFR part 814, subpart 

E), including the submission of periodic 

reports under § 814.84. 

Collecting or transfusing facilities and 

manufacturers have certain 

responsibilities under Federal 

regulations. For example, collecting or 

transfusing facilities are required to 

maintain records of any reports of 

complaints of adverse reactions (21 CFR 

606.170), while the manufacturer is 

responsible for conducting an 

investigation of each event that is 

reasonably known to the manufacturer 

and evaluating the cause of the event 

(§ 803.50(b)). In addition, manufacturers 

of medical devices are required to 

submit to FDA individual adverse event 

reports of death, serious injury, and 

malfunctions (§ 803.50). 

In the special control guidance 

document, FDA recommends that 

manufacturers include in their three 

annual reports a summary of adverse 

reactions maintained by the collecting 

or transfusing facility, or similar reports 

of adverse events collected, in addition 

to those required under the MDR 

regulation. The MedWatch medical 

device reporting code instructions 

(http://www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/

GuidanceDocuments/ucm106737.htm) 

contains a comprehensive list of adverse 

events associated with device use, 

including most of those events that we 

recommend summarizing in the annual 

report. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Reporting activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Annual Report ...................................................................... 4 1 4 5 20 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on FDA records, there are 

approximately four manufacturers of 

automated blood cell separator devices. 

The estimated average burden per 

response is based on the time that the 

manufacturers will spend preparing and 

submitting the annual report. 

Other burden hours required for 

§ 864.9245 are reported and approved 

under OMB control number 0910–0120 

(premarket notification submission 

501(k), 21 CFR part 807, subpart E), and 

OMB control number 0910–0437 (MDR, 

part 803). 

Dated: January 23, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–01626 Filed 1–28–15; 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. 

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 March 2, 

2015. 

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: FDA 

PRA Staff, Office of Operations, Food 

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Federal Register / Vol. 80, No. 19 / Thursday, January 29, 2015 / Notices 4929 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, 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 800, 801, and 809 (OMB Control 

Number 0910–0485)—Extension 

Section 502 of the Federal Food, Drug, 

and Cosmetic Act (the 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 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 as well as 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. 

FDA issued these regulations under the 

authority of sections 201, 301, 502, and 

701 of the FD&C Act (21 U.S.C. 321, 

331, 352, and 371). Most of the 

regulations under parts 800, 801, and 

809 are derived from requirements of 

section 502 of the FD&C Act, which 

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 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. 

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 must 

bear a statement of 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. 

For prescription by a licensed 

practitioner, § 801.110 establishes 

labeling requirements for a prescription 

device delivered to the ultimate 

purchaser or user. 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 when 

a nonsterile device is assembled or 

packaged with labeling that identifies 

the final finished device as sterile, for 

which the device is ultimately 

introduced into interstate commerce to 

an establishment or contract 

manufacturer to be sterilized. When a 

written agreement complies with the 

requirements under § 801.150(e), FDA 

takes no regulatory action against the 

device as being misbranded or 

adulterated. 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. 

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 

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4930 Federal Register / Vol. 80, No. 19 / Thursday, January 29, 2015 / Notices 

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’s 

(ANSI) ‘‘Specification of Hearing Aid 

Characteristics,’’ ANSI S3.22–1996 

(ASA 70–1996), (Revision of ANSI 

S3.22–1987), 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 comments, 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 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)(1) 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 identifying its 

intended use, instructions for use, lot or 

control number, and source. 

Section 809.10(e) provides that the 

labeling for ‘‘Analytic Specific 

Reagents’’ (ASRs) must provide 

information identifying the quantity or 

proportion 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 must include 

information on the intended use, 

specimen collection instructions, 

identification system, and information 

about use of the test results. In addition, 

§ 809.10(f) requires that this information 

be in language appropriate for the 

intended users. 

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 August 01, 

2014 (79 FR 44782), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity/21 CFR Section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

Processing, labeling, or repacking agreement— 

801.150(a)(2) .................................................................... 4,870 739 3,598,930 0.50 1,799,465 

Impact resistant lenses; invoices, shipping documents, 

and records of sale or distribution—801.410(e) and (f) ... 1,136 924,100 27,723,000 0.0008 22,178 

Hearing aid records—801.421(d) ........................................ 10,000 160 1,600,000 0.25 400,000 

Menstrual tampons, sampling plan for measuring absorbency—801.430(f) .............................................................. 22 8 176 80 14,080 

Latex condoms; justification for the application of testing 

data to the variation of the tested product—801.435(g) .. 63 6 378 1 378 

Total .............................................................................. ........................ ........................ ........................ ........................ 2,236,101 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 80, No. 19 / Thursday, January 29, 2015 / Notices 4931 

TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Activity/21 CFR section Number of 

respondents 

Number of 

disclosures per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

Contact lens cleaning solution labeling—800.10(a)(3) and 

800.12(c) ........................................................................ 17 8 136 1 136 

Liquid ophthalmic preparation labeling—800.10(b)(2) ....... 17 8 136 1 136 

Manufacturer, packer, or distributor information—801.1 ... 13,780 7 96,460 1 96,460 

Adequate directions for use—801.5 .................................. 6,657 6 39,942 22.35 892,704 

Statement of identity—801.61 ........................................... 6,657 6 39,942 1 39,942 

Declaration of net quantity of contents—801.62 ............... 6,657 6 39,942 1 39,942 

Prescription device labeling—801.109 .............................. 7,558 6 45,348 17.77 805,834 

Retail exemption for prescription devices—801.110 ......... 30,000 667 20,010,000 0.25 5,002,500 

Processing, labeling, or repacking; non-sterile devices— 

801.150(e) ...................................................................... 377 34 12,818 4 51,272 

Labeling of articles intended for lay use in the repairing 

and/or refitting of dentures—801.405(b)(1) .................... 31 1 31 4 124 

Dentures; information regarding temporary and emergency use—801.405(c) .................................................. 31 1 31 4 124 

Labeling requirements for hearing aids—801.420(c)(1) .... 86 12 1,032 40 41,280 

Technical data for hearing aids—801.420(c)(4) ................ 86 12 1,032 80 82,560 

Hearing aids, opportunity to review user instructional brochure—801.421(b) .......................................................... 10,000 160 1,600,000 0.30 480,000 

Hearing aids, availability of user instructional brochure— 

801.421(c) ...................................................................... 10,000 5 50,000 0.17 8,500 

User labeling for menstrual tampons—801.430(d) ............ 22 8 176 2 352 

Menstrual tampons, ranges of absorbency— 

801.430(e)(2) .................................................................. 22 8 176 2 352 

User labeling for latex condoms—801.435(b), (c), and (h) 63 6 378 100 37,800 

Labeling for IVDs—809.10(a) and (b) ............................... 1,700 6 10,200 80 816,000 

Labeling for general purpose laboratory reagents— 

809.10(d)(1) .................................................................... 300 2 600 40 24,000 

Labeling for analyte specific reagents—809.10(e) ............ 300 25 7,500 1 7,500 

Labeling for OTC test sample collection systems for 

drugs of abuse testing—809.10(f) .................................. 20 1 20 100 2,000 

Advertising and promotional materials for ASRs— 

809.30(d) ........................................................................ 300 25 7,500 1 7,500 

Labeling of sunlamp products—1040.20(d) ....................... 30 1 30 10 300 

Total ............................................................................ ........................ .......................... ........................ ........................ 8,437,318 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Dated: January 23, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–01668 Filed 1–28–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0509] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Appeals of 

Science-Based Decisions Above the 

Division Level at the Center for 

Veterinary Medicine 

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 March 2, 

2015. 

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 0910–0566. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002 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. 

Appeals of Science-Based Decisions 

Above the Division Level at CVM—21 

CFR 10.75 (OMB Control Number 0910– 

0566—Revision) 

Respondents: Respondents to this 

collection of information are applicants 

that wish to submit a request for review 

of a scientific dispute. 

The Center for Veterinary Medicine’s 

(CVM’s) guidance for industry #79 

entitled ‘‘Dispute Resolution Procedures 

for Science-Based Decisions on Products 

Regulated by the Center for Veterinary 

Medicine,’’ describes the process by 

which CVM formally resolves disputes 

relating to scientific controversies. A 

scientific controversy involves issues 

concerning a specific product regulated 

by CVM related to matters of technical 

expertise and requires specialized 

education, training, or experience to be 

understood and resolved. Further, the 

mstockstill on DSK4VPTVN1PROD with NOTICES