48866 Federal Register / Vol. 76, No. 153 / Tuesday, August 9, 2011 / Notices 

for leaders of Tribal Governments 

operating Head Start and Early Head 

Start programs in Region X and in 

Alaska. The Consultation Session for 

Region X will take place Monday, 

October 17, 2011, in Seattle, 

Washington. The Consultation Session 

for the State of Alaska will take place 

Wednesday, October 19, 2011, in 

Anchorage, Alaska, immediately 

preceding the annual Alaska Federation 

of Natives convention. We are 

convening the OHS Tribal Consultations 

in conjunction with other Tribal Leader 

events in order to minimize the 

financial and travel burden for 

participants. 

The agendas for both scheduled OHS 

Tribal Consultations will be organized 

around the statutory purposes of Head 

Start Tribal Consultations related to 

meeting the needs of American Indian 

and Alaska Native children and 

families, taking into consideration 

funding allocations, distribution 

formulas, and other issues affecting the 

delivery of Head Start services in their 

geographic locations. In addition, OHS 

will share actions taken and in progress 

to address the issues and concerns 

raised in 2010 OHS Tribal 

Consultations. 

Tribal leaders and designated 

representatives interested in submitting 

written testimony or proposing specific 

agenda topics for the Seattle or 

Anchorage Consultation Sessions 

should contact Camille Loya at 

Camille.Loya@acf.hhs.gov at least three 

days in advance of the Session. 

Proposals should include a brief 

description of the topic area along with 

the name and contact information of the 

suggested presenter. 

The Consultation Sessions will be 

conducted with elected or appointed 

leaders of Tribal Governments and their 

designated representatives [42 

U.S.C.9835, Section 640(l)(4)(A)]. 

Designees must have a letter from the 

Tribal Government authorizing them to 

represent the Tribe. The letter should be 

submitted at least three days in advance 

of the Consultation Session to Camille 

Loya at (202) 205–9721 (fax). Other 

representatives of Tribal organizations 

and Native nonprofit organizations are 

welcome to attend as observers. 

A detailed report of each Consultation 

Session will be prepared and made 

available within 90 days of the 

Consultation Session to all Tribal 

Governments receiving funds for Head 

Start and Early Head Start programs. 

Tribes wishing to submit written 

testimony for the report should send 

testimony to Camille Loya at 

Camille.Loya@acf.hhs.gov either prior to 

the Consultation Session or within 30 

days after the meeting. 

Oral testimony and comments from 

the Consultation Session will be 

summarized in the report without 

attribution, along with topics of concern 

and recommendations. Hotel and 

logistical information for all 

Consultation Sessions has been sent to 

Tribal leaders via e-mail and posted on 

the Head Start Resource Center Web site 

at http:// 

www.headstartresourcecenter.org. 

Dated: August 1, 2011. 

Yvette Sanchez Fuentes, 

Director, Office of Head Start. 

[FR Doc. 2011–20071 Filed 8–8–11; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0116] 

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 September 

8, 2011. 

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 e-mailed 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: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, Daniel.Gittleson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Medical Device Labeling Regulations— 

(OMB Control 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. 

Reporting 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. 


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Federal Register / Vol. 76, No. 153 / Tuesday, August 9, 2011 / Notices 48867 

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 

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 801.430(f) establishes 

requirements that manufacturers of 

menstrual tampons devise and follow an 

ongoing sampling plan for measuring 

the absorbency of menstrual tampons. 

Further, manufacturers must use the 

method and testing parameters 

described under § 801.430(f). 

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 device and the accompanying 

labeling (package insert), must contain 

information identifying its intended use, 

instructions for use and 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) provides that 

manufacturers of sunlamp products and 

ultraviolet lamps are subject to the 

labeling regulations under part 801. 


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48868 Federal Register / Vol. 76, No. 153 / Tuesday, August 9, 2011 / Notices 

Recordkeeping Burden 

Section 801.150(a)(2) establishes 

recordkeeping requirements for 

reprocessors, relabelers, or repackagers 

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), upon their 

request. 

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 801.410(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) requires hearing 

aid dispensers to retain a copy of any 

written statement from a physician 

required under § 801.421(a)(1), or any 

written statement waiving medical 

evaluation required under 

§ 801.421(a)(2)(iii) for 3 years after the 

dispensing of the hearing aid. 

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. 

In the Federal Register of March 14, 

2011 (76 FR 13623), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. In response to that notice, 

one comment was received. The 

comment questioned the accuracy of 

FDA’s estimate of the number of 

respondents reporting under 21 CFR 

1040.20(d) regarding sunlamp labeling 

requirements. Specifically, the comment 

suggested that the Agency provided a 

low estimate, however the comment did 

not provide a basis by which FDA may 

make an alternative estimate. FDA based 

its estimate on the number of sunlamp 

manufacturers currently registered in 

FDA’s Uniform Registration and Listing 

System (FURLS) database. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section No. of 

respondents 

No. of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response 

(in hours) 

Total hours 

800.10(a)(3) and 800.12(c) ................................................ 37 100 3,700 1 3,700 

800.10(b)(2) ....................................................................... 37 100 3,700 1 3,700 

801.1 .................................................................................. 23,393 6 140,358 .1 140,036 

801.5 .................................................................................. 5,000 3 .5 17,500 22 .35 391,125 

801.61 ................................................................................ 5,000 3 .5 17,500 1 17,500 

801.62 ................................................................................ 1,000 5 5,000 1 5,000 

801.109 .............................................................................. 18,000 3 .5 63,000 17 .77 1,119,510 

801.110 .............................................................................. 10,000 50 500,000 0 .25 125000 

801.150(e) .......................................................................... 90 20 1,800 4 7,200 

801.405(b)(1) ..................................................................... 99 1 .7 168 4 673 

801.405(c) .......................................................................... 99 1 .7 168 4 673 

801.420(c)(1) ...................................................................... 275 5 1,375 40 55,000 

801.420(c)(4) ...................................................................... 275 5 1,375 80 110,000 

801.421(b) .......................................................................... 10,000 160 1,600,000 0 .30 480,000 

801.421(c) .......................................................................... 10,000 5 50,000 0 .17 8,500 

801.430(d) .......................................................................... 45 2 90 2 180 

801.430(e)(2) ..................................................................... 45 2 90 2 180 

801.430(f) ........................................................................... 45 2 90 80 7,200 

801.435(b), (c), and (h) ...................................................... 86 3 .4 292 100 29,200 

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

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

809.10(e) ............................................................................ 300 25 7,500 1 7,500 

809.10(f) ............................................................................. 20 1 20 100 2,000 

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

1040.20(d) .......................................................................... 110 1 110 10 1,100 

TOTAL ........................................................................ ........................ ........................ ........................ .......................... 3,362,477 

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

TABLE 2—ESTIMATED AVERAGE ANNUAL RECORDKEEPING BURDEN 1

21 CFR section No. of recordkeepers 

No. of records 

per recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

(in hours) 

Total hours 

801.150(a)(2) ....................................................................... 57 1 57 0 .50 29 

801.410(e) and (f) ................................................................ 1,136 924,100 27,723,000 0 .0008 22,178 

801.421(d) ............................................................................ 10,000 160 1,600,000 0 .25 400,000 


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Federal Register / Vol. 76, No. 153 / Tuesday, August 9, 2011 / Notices 48869 

TABLE 2—ESTIMATED AVERAGE ANNUAL RECORDKEEPING BURDEN 1—Continued 

21 CFR section No. of recordkeepers 

No. of records 

per recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

(in hours) 

Total hours 

TOTAL .......................................................................... ........................ ........................ ........................ ........................ 422,207 

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

The medical device labeling 

regulations also refer to currently 

approved collections of information 

found in FDA regulations. The 

collections of information under 

§ 800.12(d) and 801.437(i) have been 

approved under OMB control number 

0910–0183; the collections of 

information under § 800.12(e) have been 

approved under OMB control number 

0910–0231; and the collections of 

information under § 801.435(g) have 

been approved under OMB control 

number 0910–0073. 

Further, FDA concludes that labeling 

statements under §§ 801.63, 

801.405(b)(2) and (b)(3), 801.420(c)(2) 

and (c)(3), 801.430(c) and (e)(1), 

801.433, 801.437(d) through (g), and 

809.30(d)(2), (d)(3), and (e) do not 

constitute a ‘‘collection of information’’ 

under the PRA. Rather, these labeling 

statements are ‘‘public disclosure’’ of 

information originally supplied by the 

Federal Government to the recipient for 

the purpose of ‘‘disclosure to the 

public’’ (5 CFR 1320.3(c)(2)). 

Reporting 

These estimates are based on FDA’s 

registration and listing database for 

medical device establishments and 

FDA’s knowledge of and experience 

with device labeling. 

Recordkeeping 

These estimates are based on FDA’s 

registration and listing database for 

medical device establishments, Agency 

communications with industry, and 

FDA’s knowledge of and experience 

with device labeling. 

The medical device labeling 

regulations also refer to previously 

approved collections of information. 

The collections of information under 

§ 800.12(d) and 801.437(i) have been 

approved under OMB control number 

0910–0183; and the collections of 

information under § 800.12(e) have been 

approved under OMB control number 

0910–0231. 

The information collection 

requirements under § 801.63, 

801.405(b)(2) and (b)(3), 801.420(c)(2) 

and (c)(3), 801.430(c) and (e)(1), 

801.433, 801.437(d) through (g), and 

809.30(d)(2), (d)(3), and (e) are not 

considered information collection 

because the public information is 

originally supplied by the Federal 

Government to the recipient for the 

purpose of disclosure to the public (5 

CFR 1320.3(c)(2)). 

Dated: August 3, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–20098 Filed 8–8–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0064] 

Ray Nathan; Denial of Hearing; Final 

Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is denying Ray 

Nathan’s request for a hearing and is 

issuing an order under the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act) permanently debarring 

Nathan from providing services in any 

capacity to a person that has an 

approved or pending drug product 

application. FDA bases this order on a 

finding that Nathan was convicted of a 

felony under Federal law for conduct 

relating to the development or approval, 

including the process for development 

or approval, of any drug product. 

Nathan has failed to file with the 

Agency information and analysis 

sufficient to create a basis for a hearing 

concerning this action. 

DATES: This order is effective August 9, 

2011. 

ADDRESSES: Submit applications for 

termination of debarment to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: G. 

Matthew Warren, Office of Scientific 

Integrity, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, rm. 4210, Silver Spring, 

MD 20993, 301–796–4613. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On May 3, 2007, the U.S. District 

Court for the District of Massachusetts 

entered a criminal judgment against 

Nathan pursuant to his guilty plea for 

wire fraud under 18 U.S.C. 1343 and 

1342. The basis for this conviction was 

Nathan’s scheme to obtain from Lyne 

Laboratories (Lyne) a copy of a 

certificate of analysis for the drug 

PhosLo to determine how to 

manufacture a generic version of the 

drug. Nathan, a founder of a startup 

drug company named Argus 

Therapeutics (Argus), admitted that he 

created a fake email account for a senior 

employee at Nabi Biopharmaceuticals 

(Nabi), a Florida company. In an effort 

to obtain the certificate of analysis, he 

then sent an email from that account to 

an employee at Lyne, which 

manufactured PhosLo as a subcontractor 

for Nabi. When the Lyne employee 

requested a physical address to which 

the certificate should be sent, Nathan 

provided the address of another 

principal at Argus via email. Nathan 

subsequently sent a third email from the 

fraudulent email account to inquire 

about the status of his request. 

Nathan is subject to debarment based 

on a finding, under section 306(a)(2)(A) 

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

335a(a)(2)(A)), that he was convicted of 

a felony under Federal law for conduct 

relating to the development or approval, 

including the process for development 

or approval, of any drug product. By a 

letter dated March 2, 2010, FDA served 

Nathan a notice proposing to 

permanently debar him from providing 

services in any capacity to a person 

having an approved or pending drug 

product application. In a letter dated 

April 6, 2010, Nathan requested a 

hearing on the proposal, and he 

submitted materials in support of that 

request on May 10, 2010. In his request 

for a hearing, Nathan acknowledges his 

conviction for wire fraud under Federal 

law, as alleged by FDA. However, he 

argues that the conduct underlying the 

conviction does not relate to the 

development or approval, including the 


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