69156 Federal Register / Vol. 70, No. 218 / Monday, November 14, 2005 / Notices 

minority status (e.g. co-sponsorship of a 

publication; co-sponsorship of a Web 

site or Web-based materials for existing 

Web sites); 

(b) Develop and disseminate a 

nationwide educational campaign, 

including advertisements and/or public 

service announcements (print, TV, and/ 

or radio) to alert individuals and diverse 

media markets about the dangers of a 

sedentary lifestyle and to promote cosponsored programs that might be 

developed in the course of this 

initiative. This might include but is not 

limited to the President’s Challenge, a 

free, motivational tool and recognition 

program of the PCPFS; 

(c) Create, develop, and evaluate 

effective programs and activities for 

physical activity, fitness and sports; 

such programs would provide evidencebased results and best practices; 

(d) Co-sponsor the development and 

management of a CEO/Business roundtable to raise awareness of the need for 

a fit and healthy workforce and to stress 

the potential role of business in 

fostering and promoting healthy 

lifestyles among employees and their 

families in an effort to reduce chronic 

disease and health care costs; 

(e) Conduct educational and/or 

practical physical activity, fitness, and/ 

or sports clinics in diverse venues (e.g. 

after school programs; senior activity 

centers; parks and recreation centers; 

others); 

(f) Create a ‘‘Road Show’’ celebrating 

50 years of fitness by providing 

demonstrations and coaching lessons for 

all ages that can be continued at the 

local level; 

(g) Sponsor 50th Anniversary 

memorabilia for distribution at such 

venues as health fairs, athletic events, 

special events, and similar occasions; 

(h) Sponsor 50th Anniversary special 

events; 

(i) Any combination or enhancement 

of the above activities; 

(j) Other innovative ideas. 

Partnership/Co-Sponsorship 

Agreements 

This Partnership Initiative is not a 

grant or contract award program. Any 

partnership formed between the Office 

of the PCPFS and an outside 

organization will be a voluntary 

collaboration. Each partner will be 

responsible for providing the resources 

necessary to carry out the specified 

activities of mutual interest contained in 

the organization’s proposal. The Office 

of the PCPFS will execute, in advance, 

a concise, written agreement with 

collaborating partner(s). The 

partnership/co-sponsorship agreement 

will identify key elements of the project 

including: Goals and intended benefits; 

roles and responsibilities of each 

partner; resources each plans to commit 

to the project; any reporting plans; and 

the time period in which the 

partnership remains in effect. 

Partnership/co-sponsorship 

agreements will make clear that there 

will be no Federal endorsement of 

commercial products or of particular 

companies. The Office of the PCPFS 

will have a right to review the use of 

any Departmental logo and statement 

related to the Office of the PCPFS 

programs or materials and products to 

ensure that they are suitable for the 

initiative and that government 

neutrality with respect to commercial 

products is maintained. When any 

Departmental logo is approved for use 

on commercial materials or products 

that promote the goals and mission of 

the Office of the PCPFS and its program 

activities, a disclaimer will be required. 

The disclaimer must be printed on, or 

affixed to, commercial partner materials 

and products and indicate that the use 

of the logo does not imply any Federal 

endorsement or warranty of a particular 

commercial product or of other products 

of a particular company. 

Evaluation Criteria 

After engaging in exploratory 

discussions of potential partnerships 

and partnership activities, the Office of 

the PCPFS will make a determination 

whether the Office of the PCPFS will 

engage in partnership activities with 

particular entities and the scope of those 

activities. The final decision to establish 

a partnership agreement with an outside 

organization will be made by the Office 

of the PCPFS Executive Director. The 

Office of the PCPFS Executive Director 

reserves the right to decline partnership 

opportunities that are not consistent 

with the Office of the PCPFS goals, 

mission, or priorities, or for reasons of 

limited federal resources available to 

appropriately manage and oversee a 

proposed partnership. Depending on 

circumstances, a variety of objective and 

subjective criteria may be applied. The 

following factors will be considered 

when selecting partners and 

determining the scope of partnership 

activities: 

1. Is the proposed project consistent 

with the mission and priorities of the 

Office of the PCPFS and the outside 

organization? 

2. Are the activities proposed by the 

offering entity likely to provide a 

substantial public benefit relative to the 

resources required? 

3. Do the potential benefits of the 

proposed partnership outweigh any 

potential negative impact on the 

Department and its ability to 

accomplish its mission? For example, 

the Department will avoid any 

appearance that an offering entity’s cosponsorship of an event would 

improperly influence the Department or 

any HHS employee in other official 

matters in which the offering entity may 

have an interest. It may be possible to 

structure a proposal to minimize 

potential issues. 

4. Does the outside entity have the 

expertise and capacity to carry out its 

proposed activities? 

5. Has the outside entity 

demonstrated a willingness to work 

collaboratively with other public and 

private sector organizations to achieve 

the stated goals or to advance related 

efforts, activities, or initiatives? 

Organizations that have goals and 

interests consistent with the mandate of 

the Office of the PCPFS are encouraged 

to reply to this notice. Such 

organizations should have appropriate 

expertise and resources and be willing 

to pursue and enhance physical activity, 

fitness, and/or sports activities within 

their own organizations. Organizations 

that meet the criteria are encouraged to 

reply to this notice. 

Working collaboratively with its 

partners, the Office of the PCPFS and its 

partners will provide innovative 

opportunities in diverse venues to 

improve the adoption and maintenance 

of regular physical activity for the 

enhanced health and well-being of all 

Americans during the 50th anniversary 

year and beyond. 

Dated: November 7, 2005. 

Melissa Johnson, 

Executive Director, President’s Council on 

Physical Fitness and Sports, Department of 

Health and Human Services. 

[FR Doc. 05–22532 Filed 11–10–05; 8:45 am] 

BILLING CODE 4150–35–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2004D–0555] 

Draft Guidance for Industry and Food 

and Drug Administration Staff; Class II 

Special Controls Guidance Document: 

Labeling for Male Condoms Made of 

Natural Rubber Latex; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

Federal Register / Vol. 70, No. 218 / Monday, November 14, 2005 / Notices 69157 

entitled ‘‘Class II Special Controls 

Guidance Document: Labeling for Male 

Condoms Made of Natural Rubber 

Latex.’’ This draft guidance document 

describes a means by which natural 

rubber latex (latex) condoms with and 

without spermicidal lubricant 

containing nonoxynol–9 (N–9) may 

comply with the requirement of special 

controls for class II devices. Elsewhere 

in this issue of the Federal Register, 

FDA is publishing a proposed rule to 

amend the classification regulations for 

condoms with and without spermicidal 

lubricant to designate this draft 

guidance as the special control for latex 

condoms with and without spermicidal 

lubricant. This draft guidance is neither 

final nor is it in effect at this time. 

DATES: Submit written or electronic 

comments on this draft guidance by 

February 13, 2006. Submit written or 

electronic comments on the information 

collection by January 13, 2006. 

ADDRESSES: Submit written requests for 

single copies on a 3.5′′ diskette of the 

draft guidance document entitled ‘‘Class 

II Special Controls Guidance Document: 

Labeling for Male Condoms Made of 

Natural Rubber Latex’’ to the Division of 

Small Manufacturers, International, and 

Consumer Assistance (HFZ–220), Center 

for Devices and Radiological Health, 

Food and Drug Administration, 1350 

Piccard Dr., Rockville, MD 20850. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request or fax your request to 301–443–

8818. See the SUPPLEMENTARY

INFORMATION section for information on 

electronic access to the draft guidance 

document. 

Submit written comments concerning 

this draft guidance to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic comments to http:// 

www.fda.gov/dockets/ecomments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: John 

Farnham, Center for Devices and 

Radiological Health (HFZ–332), Food 

and Drug Administration, 2094 Gaither 

Rd., Rockville, MD 20850, 240–276–

0115. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The draft special controls guidance 

document, announced in this document, 

describes a means by which latex 

condoms with and without spermicidal 

lubricant may comply with the 

requirement of special controls for class 

II devices. Following is a brief overview 

of the regulatory history of these devices 

and an overview of the draft special 

controls guidance document. The 

preamble to the proposed rule, which is 

published elsewhere in this Federal 

Register, provides more detail on the 

regulatory history of these devices and 

FDA’s examination of condom labeling. 

A. Overview of Regulatory History 

Condoms are devices that were on the 

market prior to the enactment of the 

Medical Device Amendments of 1976 

and were intended for contraceptive and 

prophylactic (preventing transmission 

of sexually transmitted diseases (STDs)) 

uses. Condoms are classified at 

§ 884.5300 (21 CFR 884.5300). 

Condoms with spermicidal lubricant 

containing N–9 were introduced to the 

market after the enactment of the 

Medical Device Amendments. As 

discussed in more detail in the 

preamble to the proposed rule 

published elsewhere in this Federal 

Register, since 1982, condoms with 

spermicidal lubricant containing N–9 

have been required to bear a 

contraceptive effectiveness statement to 

be classified under § 884.5310. This 

contraceptive effectiveness statement 

was part of the reclassification order for 

condoms with spermicidal lubricant on 

October 29, 1982 (47 FR 49021). 

Both condoms and condoms with 

spermicidal lubricant containing N–9 

are classified in class II. Both were 

originally classified before the 

enactment of provisions of the Safe 

Medical Devices Act of 1990 that 

broadened the definition of class II 

devices and now permit FDA to 

establish special controls beyond 

performance standards to help provide 

reasonable assurance of the safety and 

effectiveness of such devices. The notice 

of proposed rulemaking published 

elsewhere in this issue of the Federal 

Register proposes to establish this draft 

guidance document as such a special 

control. Both condoms and condoms 

with spermicidal lubricant have also 

been the subject of specific labeling 

requirements and recommendations, as 

discussed next. 

In 1987, shortly after the U.S. Surgeon 

General recommended using a condom 

for protection against Human 

Immunodeficiency Virus (HIV) and 

Acquired Immune Deficiency Syndrome 

(AIDS), FDA issued a letter to condom 

manufacturers with recommendations 

on condom labeling. This letter was part 

of a far-reaching public health campaign 

to inform the American public about 

AIDS, which was identified in 1981 and 

associated with HIV and sexual 

transmission vectors in 1983. The 

purpose of FDA’s 1987 letter was to 

improve existing condom labeling to 

better inform condom users about 

protecting themselves against the spread 

of HIV/AIDS and other STDs. In 1989, 

FDA issued a letter further explaining 

its policy on condom labeling and the 

necessity of including in the labeling a 

statement of the condom’s intended 

use(s). 

In 1997, FDA published final labeling 

regulations applicable to latex condoms 

that address expiration dating and latex 

sensitivity (§§ 801.435 and 801.437 (21 

CFR 801.435 and 801.437)). FDA 

established expiration dating 

requirements in response to information 

that showed that the effectiveness of 

latex condoms as a barrier to sexually 

transmitted diseases, including HIV, is 

dependent upon the integrity of the 

latex material. The expiration dating 

regulation of September 26, 1997, 

addresses the risk of condom 

deterioration due to product aging and 

helps ensure that consumers have 

information regarding the safe use of 

latex condoms (62 FR 50497 at 50501). 

The latex sensitivity labeling 

requirements of September 30, 1997, 

were added in response to numerous 

reports of severe allergic reactions and 

deaths related to a wide range of 

medical devices containing natural 

rubber (62 FR 51021 at 51029). 

In July 1998, to encourage 

conformance with condom performance 

standards, FDA issued a guidance 

document entitled ‘‘Latex Condoms for 

Men: Information for 510(k) Premarket 

Notifications: Use of Consensus 

Standards for Abbreviated 

Submissions,’’ which outlined FDA’s 

‘‘abbreviated review’’ approach toward 

510(k)s for condoms. To qualify for an 

abbreviated review, the condom 

manufacturer must declare conformance 

to standards recognized by FDA in 

accordance with section 514(c) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 360d). This guidance also 

carried forward previously issued 

guidance on suggested labeling for the 

primary retail package and the package 

insert, as well as the foil wrapper for 

individual condoms. In particular, FDA 

guidance suggested that labeling on the 

primary package address contraception, 

and also include the following 

statement regarding STDs: ‘‘If used 

properly, latex condoms will help to 

reduce the risk of transmission of HIV 

infection (AIDS) and many other 

sexually transmitted diseases.’’

This same statement was also 

recommended for the individual foil 

wrapper of the condom. 

FDA also carried forward a labeling 

recommendation for the package insert 

69158 Federal Register / Vol. 70, No. 218 / Monday, November 14, 2005 / Notices 

to include the following expanded 

version of the previous statement: 

If used properly, latex condoms will 

help to reduce the risk of transmission 

of HIV infection (AIDS) and many other 

sexually transmitted diseases, including 

chlamydia infections, genital herpes, 

genital warts, gonorrhea, hepatitis B, 

and syphilis. 

In December 2000, Congress enacted 

Public Law 106–554, which among 

other provisions, directed FDA to 

‘‘reexamine existing condom labels’’

and ‘‘determine whether the labels are 

medically accurate regarding the overall 

effectiveness or lack of effectiveness of 

condoms in preventing sexually 

transmitted diseases, including [human 

papillomavirus (HPV)].’’ In reexamining condom labeling as directed 

by Public Law 106–554, and in the 

development of the draft special 

controls guidance document, FDA 

considered the following points: 

• Physical properties of condoms; 

• Condom slippage and breakage 

during actual use, 

• Plausibility for STD risk reduction 

attributable to condoms, 

• Evaluations of condom 

effectiveness against STDs by other 

Federal agencies, 

• Clinical data regarding condom 

protection against STDs, 

• Information on N–9 and 

contraception. 

The information FDA considered 

during the course of its re-examination 

of the medical accuracy of condom 

labeling and its analysis support the 

conclusion that condoms reduce the 

overall risk of STD transmission, 

although the degree of risk reduction for 

different types of STDs varies with their 

routes of transmission. The preamble to 

the proposed rule designating this draft 

guidance as a special control for male 

condoms made of natural rubber latex, 

published elsewhere in this Federal 

Register, discusses in detail FDA’s 

review and resulting conclusions, which 

form the basis for the recommendations 

made in the draft guidance document. 

B. Overview of Guidance 

The recommendations in the draft 

guidance reflect the FDA’s reexamination of the medical accuracy of 

condom labeling, as required by Public 

Law 106–554. The draft guidance 

document describes a means by which 

latex condoms with and without 

spermicidal lubricant may comply with 

the requirement of special controls for 

class II devices. The draft guidance 

document identifies the issues requiring 

special controls associated with these 

devices and recommends addressing 

these issues through labeling. 

The labeling recommendations in the 

draft guidance are intended to provide 

information to users of latex condoms 

with and without spermicidal lubricant. 

The draft special controls guidance 

recommends labeling to inform users 

about the extent of protection provided 

by condoms against unintended 

pregnancy and against various types of 

STDs, as well as information about 

possible risks associated with exposure 

to N–9 contained in the spermicidal 

lubricant of some condoms. The 

labeling recommendations provide 

important information for condom users 

to assist them in determining whether 

latex condoms are appropriate for their 

needs and, if so, to determine whether 

a condom with or without N–9 lubricant 

is most suitable. FDA believes that this 

draft guidance is an appropriate special 

control to help provide reasonable 

assurance of the safety and effectiveness 

of latex condoms and latex condoms 

with spermicidal lubricant containing 

N–9. 

At this time, FDA is not proposing to 

designate a special control for any 

condoms made of natural membrane 

(skin) or synthetic materials. 

Discussions with the condom industry 

indicate that condoms made from 

natural rubber latex represent nearly 98 

percent of the U.S. retail market for 

condoms. The agency understands that 

all condoms distributed by public 

health and other organizations are also 

made from natural rubber latex, based 

on its discussions with manufacturers. 

The agency believes, therefore, that the 

recommendations in the draft special 

controls guidance document address the 

vast majority of condoms distributed in 

the United States. However, at a future 

date, FDA also intends to address 

condoms made from other materials that 

are not specifically addressed by this 

draft guidance. Until FDA provides 

further specific guidance for these 

products, manufacturers of synthetic 

condoms may consult Part C of FDA’s 

guidance document entitled ‘‘Testing 

Guidance for Male Condoms Made from 

New Material (June 25, 1995),’’ which is 

available at http://www.fda.gov/cdrh/ 

ode/oderp455.html, and manufacturers 

of natural membrane condoms may 

consult the guidance document entitled 

‘‘Guidance for Industry-Uniform 

Contraceptive Labeling (July 23, 1998),’’

which is available at http:// 

www.fda.gov/cdrh/ode/contrlab.html. 

FDA believes, however, that most of 

the recommendations contained in the 

draft special controls guidance 

document for latex condoms regarding 

labeling to address N–9 are also 

applicable to nonlatex condoms 

containing N–9, and encourages 

manufacturers to follow those aspects, 

as noted in the draft guidance itself. 

The labeling recommendations in the 

special controls guidance document, 

when final, will supersede statements in 

a number of documents, including: 

• FDA letter to ‘‘All U.S. Condom 

Manufacturers, Importers and 

Repackagers’’ (April 7, 1987); 

• FDA letter to ‘‘Manufacturers, 

Importers, and Repackagers of Condoms 

for Contraception or SexuallyTransmitted Disease Prevention’’

(February 13, 1989), which is available 

at http://www.fda.gov/cdrh/comp/ 

053.pdf. 

• Contraceptive effectiveness 

statement required by the 1982 

reclassification order for latex condoms 

with the spermicide, nonoxynol–9, as 

outlined in an October 29, 1982, Federal 

Register document (47 FR 49201). 

If the draft guidance is finalized, FDA 

intends to withdraw or amend other 

documents to ensure consistency with 

the labeling recommendations in the 

special controls guidance document. 

Following the finalization of this 

guidance and the implementation of any 

final classification rule designating this 

document as a special control for latex 

condoms and latex condoms with 

spermicidal lubricant, labeling for those 

devices will need to address the issues 

covered in the final special controls 

guidance document, unless the device 

manufacturer in some other way 

provides equivalent assurances of safety 

and effectiveness. 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, if finalized, will 

represent the agency’s current thinking 

on labeling for male condoms made of 

natural rubber latex. It does not create 

or confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statute 

and regulations. 

III. Electronic Access 

To receive the draft ‘‘Class II Special 

Controls Guidance Document: Labeling 

for Male Condoms Made of Natural 

Rubber Latex’’ by fax machine, call the 

CDRH Facts-On-Demand system at 800–

899–0381 or 301–827–0111 from a 

touch-tone telephone. Press 1 to enter 

the system. At the second voice prompt, 

press 1 to order a document. Enter the 

document number (1548) followed by 

the pound sign (#). Follow the 

remaining voice prompts to complete 

your request. 

Federal Register / Vol. 70, No. 218 / Monday, November 14, 2005 / Notices 69159 

Persons interested in obtaining a copy 

of the draft guidance may also do so by 

using the Internet. CDRH maintains an 

entry on the Internet for easy access to 

information including text, graphics, 

and files that may be downloaded to a 

personal computer with Internet access. 

Updated on a regular basis, the CDRH 

home page includes device safety alerts, 

Federal Register reprints, information 

on premarket submissions (including 

lists of approved applications and 

manufacturers’ addresses), small 

manufacturer’s assistance, information 

on video conferencing and electronic 

submissions, Mammography Matters, 

and other device-oriented information. 

The CDRH web site may be accessed at 

http://www.fda.gov/cdrh. A search 

capability for all CDRH guidance 

documents is available at http:// 

www.fda.gov/cdrh/guidance.html. 

Guidance documents are also available 

on the Division of Dockets Management 

Internet site at http://www.fda.gov/ 

ohrms/dockets. 

IV. Paperwork Reduction Act of 1995 

(the PRA) 

Under the PRA (44 U.S.C. 3501-3520), 

Federal agencies must obtain approval 

from the Office of Management and 

Budget (OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Title: Labeling for Male Condoms 

Made of Natural Rubber Latex 

Description: Under the Medical 

Device Amendments of 1976 (Public 

Law 94–295), class II devices were 

defined as those devices for which there 

was insufficient information to show 

that general controls themselves would 

provide a reasonable assurance of safety 

and effectiveness, but for which there 

was sufficient information to establish 

performance standards to provide such 

assurance. 

Both condoms and condoms with 

spermicidal lubricant containing N–9 

are classified in class II. Both were 

originally classified before the 

enactment of provisions of the Safe 

Medical Devices Act of 1990 (Public 

Law 101–629) that broadened the 

definition of class II devices and now 

permit FDA to establish special controls 

beyond performance standards, 

including guidance documents, to help 

provide reasonable assurance of the 

safety and effectiveness of such devices. 

In December 2000, Congress enacted 

Public Law 106–554, which among 

other provisions, directed FDA to 

‘‘reexamine existing condom labels’’

and ‘‘determine whether the labels are 

medically accurate regarding the overall 

effectiveness or lack of effectiveness in 

preventing sexually transmitted 

diseases* * *.’’ FDA is recommending 

labeling changes intended to provide 

important information for condom 

users, including the extent of protection 

provided by condoms against various 

types of STDs. 

Respondents to this collection of 

information are manufacturers and 

repackagers of male condoms made of 

natural rubber latex. FDA believes that 

this a one-time burden, because once a 

label is redesigned, it can be used 

indefinitely. 

FDA estimates the burden of this 

collection as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours 

per Response Total Hours 

352 34 1,190 12 14,280 

33 34 102 12 1,224 

Total 15,504 

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

2 Current manufacturers for year one. 

3 New manufacturers for years two and three. 

The reporting burden hours to 

respondents in the first year is a onetime burden of 14,280 hours. FDA 

expects three new manufacturers or 

repackagers to enter the market yearly, 

and collectively have a one-time burden 

of 1,224 hours. The number of 

respondents and prospective new 

manufacturers cited in table 1 of this 

document are based on FDA’s database 

of premarket submissions. The 

remaining figures were derived from a 

study performed for FDA by Eastern 

Research Group, Inc., an economic 

consulting firm, to estimate the impact 

of the 1999 Over-the-Counter (OTC) 

Human Drug Labeling Requirements 

final rule (64 FR 13254, March 17, 

1999). Because the packaging 

requirements for condoms are similar to 

those of many OTC drugs, we believe 

the burden to redesign the labeling for 

OTC drugs is an appropriate proxy for 

the estimated burden to redesign 

condom labeling. 

The latex allergy caution required by 

§ 801.437 and referenced in the draft 

guidance does not constitute a 

‘‘collection of information’’ under the 

PRA. Rather, it is a ‘‘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)). The 

expiration dating requirements 

established by § 801.435 and referenced 

in the draft guidance have been 

approved by OMB under OMB control 

number 0910–0485. 

69160 Federal Register / Vol. 70, No. 218 / Monday, November 14, 2005 / Notices 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES), written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: June 21, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–22610 Filed 11–10–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2003D–0554] 

Revised Compliance Policy Guide 

Regarding Prior Notice of Imported 

Food Under the Public Health Security 

and Bioterrorism Preparedness and 

Response Act of 2002; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a revised compliance 

policy guide (CPG) Sec. 110.310 entitled 

‘‘Prior Notice of Imported Food Under 

the Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002.’’ The CPG 

provides written guidance to FDA’s and 

Customs and Border Protection’s (CBP’s) 

staff on enforcement of section 307 of 

the Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002 (the Bioterrorism 

Act) and the agency’s implementing 

regulations, which require prior notice 

for food imported or offered for import 

into the United States. The CPG has 

been revised to finalize the sections 

pertaining to routine shipments of food 

that are transshipped through the 

United States, arriving from and exiting 

to the same country, and regarding the 

Harmonized Tariff Schedule (HTS) code 

that is part of the planned shipment 

information. 

DATES: The revised CPG is final upon 

the date of publication. However, you 

may submit written or electronic 

comments on the revised CPG at any 

time. 

ADDRESSES: You may submit comments, 

identified by Docket No. 2003D–0544 

and/ Regulatory Information Number 

(RIN) number (if a RIN number has been 

assigned), by any of the following 

methods: 

Electronic Submissions 

Submit electronic comments in the 

following ways: 

• Agency Web site: http:// 

www.fda.gov/dockets/ecomments. 

Follow the instructions for submitting 

comments on the agency Web site. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier [For 

paper, disk, or CD–ROM submissions]: 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

To ensure more timely processing of 

comments, FDA is no longer accepting 

comments submitted to the agency by email. FDA encourages you to continue 

to submit electronic comments by using 

the Federal eRulemaking Portal or the 

agency Web site, as described in the 

Electronic Submissions portion of this 

paragraph. 

Instructions: All submissions received 

must include the agency name and 

Docket No(s). and RIN (if a RIN number 

has been assigned) for this rulemaking. 

All comments received may be posted 

without change to http://www.fda.gov/ 

ohrms/dockets/default.htm, including 

any personal information provided. For 

additional information on submitting 

comments, see the ‘‘Comments’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.fda.gov/ohrms/dockets/ 

default.htm and insert the docket 

number(s), found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

Submit written requests for single 

copies of the revised guidance to the 

Division of Compliance Policy (HFC–

230), Office of Enforcement, Food and 

Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857. Send one 

self-addressed adhesive label to assist 

that office in processing your request or 

include a fax number to which the 

guidance may be sent. 

FOR FURTHER INFORMATION CONTACT: 

Laura Draski, Office of Regulatory 

Affairs (HFC–180), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 866–521–2297. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of March 4, 

2005 (70 FR 10657), FDA announced the 

availability of a draft revision to CPG 

Sec. 110.310 entitled ‘‘Prior Notice of 

Imported Food Under the Public Health 

Security and Bioterrorism Preparedness 

and Response Act of 2002.’’ This revised 

guidance was issued with CBP 

concurrence and explains to FDA and 

CBP staff the new FDA and CBP policies 

on enforcement of section 307 of the 

Bioterrorism Act and its implementing 

regulations, which require prior notice 

to FDA of all food imported or offered 

for import into the United States (21 

CFR parts 1.276 through 1.285). The 

new policies provide additional 

flexibility in filing prior notice when, 

due to the geography, the only practical 

transportation route available for the 

shipment is through the United States 

and when there is a prior notice 

violation because the prior notice does 

not include the 6-digit HTS code for the 

article of food. 

FDA received 8 comments on the 

draft sections of the revised CPG. FDA 

reviewed and evaluated these comments 

and has modified the CPG with CBP 

concurrence, where appropriate. 

FDA is issuing this CPG as level 1 

guidance consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The CPG represents the 

agency’s current thinking on its 

enforcement policy concerning prior 

notice. It does not create or confer any 

rights for or on any person and does not 

operate to bind FDA or the public. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments on the guidance document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. The revised 

CPG and received comments may be 

seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday.