67490 Federal Register / Vol. 70, No. 214 / Monday, November 7, 2005 / Notices 

special control guidance document to 

support the classification of the low 

energy ultrasound wound cleaner into 

class II (special controls). This device is 

intended for the cleaning and 

maintenance debridement of wounds. 

On April 29, 2004, Celleration, Inc., 

submitted a petition requesting 

classification of the Celleration MIST 

Therapy SystemTM under section 

513(f)(2) of the Federal Food, Drug, and 

Cosmetic Act (the act) (21 U.S.C. 

360c(f)(2)). 

Elsewhere in this issue of the Federal 

Register, FDA is publishing a final rule 

classifying the low energy ultrasound 

wound cleaner into class II (special 

controls) under section 513(f)(2) of the 

act. This guidance document will serve 

as the special control for the low energy 

ultrasound wound cleaner device. 

Section 513(f)(2) of the act provides that 

any person who submits a premarket 

notification under section 510(k) of the 

act (21 U.S.C. 360(k)) for a device that 

has not previously been classified may, 

within 30 days after receiving an order 

classifying the device in class III under 

section 513(f)(1) of the act, request FDA 

to classify the device under criteria set 

forth in section 513(a)(1) of the act. FDA 

shall, within 60 days of receiving such 

a request, classify the device by written 

order. This classification shall be the 

initial classification of the device. 

Within 30 days after the issuance of an 

order classifying the device, FDA must 

publish a notice in the Federal Register 

announcing such classification. Because 

of the timeframes established by section 

513(f)(2) of the act, FDA has 

determined, under § 10.115(g)(2) (21 

CFR 10.115(g)(2)), that is not feasible to 

allow for public participation before 

issuing this guidance as a final guidance 

document. Therefore, FDA is issuing 

this guidance document as a level 1 

guidance document that is immediately 

in effect. FDA will consider any 

comments that are received in response 

to this notice to determine whether to 

amend the guidance document. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s GGPs regulation 

in § 10.115. The guidance represents the 

agency’s current thinking on the low 

energy ultrasound wound cleaner for 

the cleaning and maintenance 

debridement of wounds. 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 ‘‘Class II Special Controls 

Guidance Document: Low Energy 

Ultrasound Wound Cleaner’’ by fax, 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 1302 followed by the 

pound sign (#). Follow the remaining 

voice prompts to complete your request. 

Persons interested in obtaining a copy 

of the 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 

This guidance contains information 

collection provisions that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (the PRA) (44 

USC 3501–3520). The collections of 

information addressed in the guidance 

document have been approved by OMB 

in accordance with PRA under the 

regulations governing premarket 

notification submissions (21 CFR part 

807, subpart E, OMB control number 

0910–0120). The labeling provisions 

addressed in the guidance have been 

approved by OMB under OMB control 

number 0910–0485. 

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 paper 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: October 5, 2005. 

Linda S. Kahan, 

Deputy Director, Center for Devices and 

Radiological Health. 

[FR Doc. 05–22069 Filed 11–4–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

DEPARTMENT OF AGRICULTURE 

Food Safety Inspection Service 

[Docket No. 05–013N] 

Meeting To Discuss Possible Changes 

to the Regulatory Jurisdiction of 

Certain Food Products Containing 

Meat and Poultry 

AGENCIES: Food and Drug 

Administration, HHS; Food Safety 

Inspection Service, USDA. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA), in the 

Department of Health and Human 

Services, and the Food Safety Inspection 

Service (FSIS), in the United States 

Department of Agriculture (USDA), are 

jointly announcing a public meeting to 

discuss and solicit information on an 

approach for providing consistency and 

predictability with respect to which of 

the two agencies should have 

jurisdiction over certain types of food 

products that contain meat and poultry 

as ingredients, as well as the opening of 

a joint agency docket to receive written 

comments. This notice outlines that 

approach and solicits comments on it 

and on the specific questions asked in 

section II below. 

DATES: The public meeting will be held 

on December 15, 2005, from 10 a.m. to 

4 p.m. 

ADDRESSES: The public meeting will be 

held at the Donald E. Stephens 

Convention Center, 5555 North River 

Road, Rosemont, IL 60018, 847–692–

0222. 

You may submit comments, identified 

with Docket No. 05–013N, by any of the 

following methods: 

• Electronic mail: 

FSIS: FSIS 

regulationsComments@fsis.usda.gov. 

Follow the instructions for submitting 

comments on the Agency’s Web site. 

Federal Register / Vol. 70, No. 214 / Monday, November 7, 2005 / Notices 67491 

1Pepperoni rolls are a product that was the 

subject of a FSIS jurisdictional decision in 1986. 

They are a product that is composed of pieces of 

pepperoni that are distributed in bread dough 

which is then baked. 

• FAX: 

FSIS: 202–690–0486. 

• Mail/Hand delivery/Courier (For 

paper, disk, or CD–ROM submissions): 

FSIS: Docket Clerk, U.S. Department 

of Agriculture, Food Safety and 

Inspection Service, 300 12th Street, 

SW., Room 102 Cotton Annex, 

Washington, DC 20250 

FDA: Division of Dockets 

Management, 5630 Fishers Lane, Room 

1061, Rockville, MD 20852. 

Instructions: All submissions received 

must include Docket No. 05–013N. All 

comments received will be posted 

without change to: (FSIS) http:// 

www.fsis.usda.gov/ 

regulations_&_policies/ 

2005_Notices_Index/index.asp.; (FDA) 

http://www.fda.gov/dockets/ecomments. 

Submissions received must include 

the Agency name and Docket No. 05–

013N. All comments submitted will be 

available for public inspection in the 

Agencies’ Docket Offices and on the 

Agencies’ Web sites. 

FOR FURTHER INFORMATION CONTACT: For 

general questions about the meeting 

contact Marion V. Allen, Center for 

Food Safety and Applied Nutrition 

(HFS–32), Food and Drug 

Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740, 301–

436–1584, FAX: 301–436–2605, e-mail: 

marion.allen@fda.hhs.gov. 

Please see Section III. Registration, for 

information on how to register for the 

Public Meeting. 

For technical questions about the 

subject of the meeting: FDA: Karen 

Carson, Director, Executive Operations 

Staff (EOS), Center for Food Safety and 

Applied Nutrition (HFS–22), Food and 

Drug Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740, 301–

436–1664, FAX: 301–436–2668, e-mail: 

kcarson@cfsan.fda.gov. 

FSIS: Philip S. Derfler, Assistant 

Administrator, Office of Policy, 

Program, and Employee Development 

(OPPED), Food Safety Inspection 

Service, 1400 Independence Ave., SW., 

Suite 350–E Whitten Building, 

Washington, DC 20250, (202) 720–2709, 

FAX: (202) 720–2025, e-mail: 

Philip.Derfler@fsis.usda.gov. 

SUPPLEMENTARY INFORMATION

I. Background 

Both FSIS and FDA have regulatory 

authority over the food supply. Under 

the Federal Meat Inspection Act (FMIA), 

Poultry Products Inspection Act (PPIA), 

and Egg Products Inspection Act (EPIA), 

FSIS has authority over all meat and 

poultry products and processed egg 

products. Under the Federal Food, Drug, 

and Cosmetic Act (FFDCA), FDA has 

authority over all foods not under FSIS’

jurisdiction (e.g., dairy, bread and other 

grain products, vegetables and other 

produce, and other products such as 

seafood). 

Over the years, FSIS has made 

jurisdictional decisions based on 

various factors, including the amount of 

meat or poultry in the product; whether 

the product is represented as a meat or 

poultry product (that is, whether a term 

that refers to meat or poultry is used on 

labeling); and whether the product is 

perceived by consumers as a product of 

the meat or poultry industries. With 

regard to the consumer perception 

factor, FSIS has made decisions on a 

case-by-case basis, mostly in response to 

situations involving compliance and 

enforcement. Although this case-by-case 

approach resulted in decisions that 

made sense at the time, a recent review 

by the agencies highlighted that some 

decisions do not appear to be fully 

consistent with other product decisions 

and that the reasoning behind various 

determinations were not fully 

articulated. For example, the reasoning 

for deciding that a ‘‘bagel dog’’ (a 

product composed of a hotdog wrapped 

in bagel dough which is then baked) 

was not a meat product was conveyed 

in a letter from FSIS to a trade 

association in 1979 (Letter from Irwin 

Fried, Acting Director, Meat and Poultry 

Standards and Labeling Division, to 

Pacific Coast Meat Association, January 

8, 1979). The letter stated that the 

product was viewed as a ‘‘closed-face’’

sandwich and, thus, was not under FSIS 

jurisdiction. However, the Agency did 

not explain why such products were 

viewed as closed-face sandwiches or the 

importance of this view. Moreover, the 

letter did not explain why bagel dogs 

were different than other products that 

were similarly configured, e.g., ‘‘corn 

dogs’’ and ‘‘sausage turnovers,’’ that 

were, and continue to be, manufactured 

under FSIS jurisdiction. 

Confusion persists about the 

reasoning used with respect to various 

decisions about which agency has 

jurisdiction over certain food products 

containing meat and poultry. For 

example, manufacturers have wanted to 

change the original formulations of 

products that were the subject of 

jurisdictional decisions, e.g., bagel dogs 

and pepperoni rolls.1 By adding new 

ingredients, e.g., adding cheese and 

other meat and poultry ingredients, 

manufacturers have created ‘‘bagel dogs 

with cheese’’ and ‘‘pepperoni, ham, and 

cheese rolls.’’ Although the 

manufacturers requested that FSIS 

categorize these new products like their 

predecessors, FSIS has denied these 

kinds of requests because, without a 

clear rationale supporting the original 

decisions, FSIS believed that confusion 

would be compounded further by 

perpetuating the rationale contained in 

the original decision. 

In other situations, manufacturers 

have expressed confusion about the 

classification of new versions of 

traditional food products because 

products with similar composition are 

produced under the jurisdiction of a 

different agency. For example, FSIS 

decided decades ago that closed-face 

sandwiches made with meat ingredients 

were not meat products and, thus, were 

products under FDA’s regulatory 

jurisdiction. Recently, manufacturers of 

‘‘wrap-type sandwiches with meat’’

have argued that wraps are similar 

enough to closed-face sandwiches such 

that wraps should fall under FDA’s 

jurisdiction. There are wrap-like 

products, (meat burritos, meat egg rolls, 

and meat tamales), which FSIS has 

categorized as meat products and which 

are more similar in composition to the 

wrap-sandwich. Because wrap-type 

sandwiches are new to the market and 

the historic decision about closed-face 

sandwiches did not include them, FSIS 

concluded that wrap-type sandwiches 

are meat products. 

These and other circumstances led 

FSIS and FDA to conduct an in-depth 

examination of the historic decisions 

about regulatory jurisdiction made by 

FSIS. An FSIS–FDA working group met 

to explore the issue and to develop an 

approach for making sound, clear, and 

transparent decisions about product 

categorization and agency jurisdiction. 

As a result of the working group’s 

findings, the agencies concluded that a 

clearer approach to determining 

jurisdiction is possible. This approach 

involves considering the contribution of 

the meat or poultry ingredients to the 

identity of the food. In some cases, the 

meat or poultry ingredients are 

distinctive and significantly contribute 

to a food’s basic nature by 

characterizing the food. In other cases, 

the meat or poultry ingredients are used 

in such a way that they do not 

contribute to the product’s basic nature 

because they are not easily 

distinguished and are used to simply 

add flavor. The agencies recognized, 

however, that application of this 

approach could lead to changes in 

jurisdiction for certain foods and 

categories of foods and thus felt that it 

was important to present this approach 

67492 Federal Register / Vol. 70, No. 214 / Monday, November 7, 2005 / Notices 

for public comment before taking steps 

to implement any changes. 

A change in jurisdiction may be in 

order for the products and product 

categories described below. Bagel dogs, 

closed-face meat and poultry-containing 

sandwiches, and natural casings, 

regulation of which would move from 

FDA to FSIS jurisdiction, are products 

or product categories characterized by 

the meat or poultry ingredients that they 

contain. Further, these products are 

identified by terms that refer to the meat 

and poultry ingredients, reflecting the 

contribution of the meat and poultry 

components. In contrast, meat and 

poultry components are added to other 

products/product categories, such as 

bread/rolls/buns, cheese products, 

flavors, pizzas, and salad dressings, to 

add flavor but not to alter the character 

of the products. Such products would 

move from FSIS to FDA jurisdiction. 

Bagel Dogs 

Bagel dogs were the subject of a 

jurisdiction decision that FSIS made 

almost 20 years ago. The decision made 

at that time was that a product 

composed of a cooked hotdog wrapped 

in bagel dough, which is baked, is not 

itself a meat product. Bagel dogs thus 

fell under FDA jurisdiction. Bagel dogs, 

however, are similar to other meatfilled, dough-encased or wrapped 

products—such as corn dogs and 

sausage turnovers—which have 

historically been under FSIS 

jurisdiction. These products are 

composed of a meat or poultry filling 

that is encased or wrapped in dough or 

crust which provides a convenient 

container for the ingredients for handheld eating. The meat and poultry 

components characterize the products 

and the characteristics of the meat/ 

poultry ingredients are not changed by 

the bread, dough, or crust around it. 

Because the agencies have not been able 

to distinguish bagel dogs from corn dogs 

and similar products, the agencies are 

considering changing the jurisdiction of 

bagel dogs from FDA to FSIS. 

Natural Casings 

At least as far back as the 1950’s, 

USDA made a jurisdictional decision 

that natural casings, which are used for 

sausages and other stuffed and formed 

meat and poultry products, are not meat 

byproducts because they serve as a 

container or packaging for the meat or 

poultry put in the casing. As a result, 

natural casings have been under FDA 

jurisdiction. But natural casings 

originate from meat byproducts, 

(specifically, from parts of livestock 

digestive tracts) which are under FSIS 

jurisdiction. The process of sanitizing 

and sizing the livestock materials does 

not change them to the degree that their 

basic identity as meat byproducts such 

as bungs, stomachs, intestines is 

changed. Therefore, the agencies are 

considering changing the jurisdiction of 

this category of products from FDA to 

FSIS. 

Closed-Face Sandwiches Made With 

Meat or Poultry 

According to FSIS policy going back 

to the 1930’s, closed-face sandwiches 

(products containing at least 35% 

cooked meat and poultry products, by 

weight, placed between 2 slices of 

bread, biscuit, or bun, which are less 

than 50 percent of the weight of the 

product) were not meat or poultry 

products because consumers viewed 

them as products primarily prepared in 

local food service establishments (FSIS 

Food Standards and Labeling Policy 

Book, 2003). Today, however, 

sandwiches containing meat or poultry 

components in their majority are made 

in manufacturing facilities and are 

shipped in interstate commerce. 

Moreover, in determining regulatory 

jurisdiction, it makes sense to consider 

the contribution of the meat ingredient 

to the product. 

Meat and poultry sandwiches are 

generally consumed for the distinctive 

meat and poultry ingredients, not for the 

bread that surrounds them. In other 

words, it is the meat or poultry 

ingredients that characterize the 

sandwich, which is not changed by the 

bread, biscuit, or bun between which 

they are placed. Furthermore, 

sandwiches are similar to the other 

meat- or poultry-filled, dough-encased 

or wrapped products that were 

discussed earlier have historically been 

under FSIS jurisdiction. Therefore, the 

agencies are considering changing the 

jurisdiction of these products from FDA 

to FSIS. 

Cheese and Cheese Products (Including 

Cheese Dips) Made With Less Than 50 

Percent Meat or Poultry 

Products that meet the standards of 

identity in 21 CFR Part 133 for Cheeses 

and Cheese Products (i.e., pasteurized 

blended cheese, process cheese, cheese 

food, cheese spread) are not considered 

meat or poultry products. The standard 

of identity for such products allows for 

optional ingredients, including meat 

ingredients. Based on this standard, 

FSIS decided many years ago that some 

cheese products such as cheese balls 

and cheese logs that include small 

pieces of inspected and passed ready-toeat meat (e.g., dried sausage or cooked 

bacon) at less than 50 percent of their 

formulation (by weight) were not meat 

products and should fall under FDA 

jurisdiction. However, this FSIS 

decision has never been extended to all 

cheese and cheese products or to those 

that contain poultry. The agencies have 

considered this decision and, as a result, 

the agencies are suggesting that the 

addition of less than 50 percent 

inspected and passed ready-to-eat meat 

or poultry ingredients does not change 

the characteristics of cheese or cheese 

products (whether or not the product is 

covered by an FDA standard of identity) 

because, at less than 50 percent of the 

weight of the product, the meat or 

poultry added is used for flavoring 

effect. Therefore, the agencies are 

considering changing the jurisdiction of 

these products from FSIS to FDA. 

Bread, Rolls, and Buns Made With Less 

Than 50 Percent Meat or Poultry 

The jurisdiction of pepperoni rolls is 

an example of a bread-based product 

that has caused confusion since a 

decision was made in 1986 by FSIS that 

such a product is not a meat product, 

and is, therefore, under FDA’s 

jurisdiction (Letter from Margaret O. 

Glavin to State of West Virginia, 

Department of Agriculture, January 8, 

1986). The original decision was made 

for a product that was composed of 

small pieces of pepperoni that were 

dispersed throughout bread dough and 

baked. At the time, the product was 

prepared in such a way that it was 

viewed by FSIS as being a product of 

the bakery industry. More recently, FSIS 

has viewed products with variations of 

the original formulation (e.g., 

pepperoni, ham, and cheese rolls) as 

meat and poultry products because 

these products are not consistent with 

the formulation of the product for which 

the original jurisdictional decision was 

made. 

In reviewing the decision about 

pepperoni rolls and the other decisions 

made about bread-based products over 

the years, the agencies considered the 

standards of identity for bakery 

products in 21 CFR Part 136, Bakery 

Products. Such products, which include 

bread, rolls, and buns, are foods 

produced by baking dough made from 

farinaceous ingredients into which 

optional ingredients may be dispersed 

for flavor. Meat and poultry are not 

permitted optional ingredients in the 

standards for breads, rolls, and buns in 

Part 136. Therefore, these foods to 

which meat or poultry are added are 

non-standardized foods. The agencies 

believe that meat and poultry 

ingredients can be added to any bakery 

product for flavoring. 

The agencies are now considering 

changing the jurisdiction from FSIS to 

Federal Register / Vol. 70, No. 214 / Monday, November 7, 2005 / Notices 67493 

FDA of the original pepperoni roll 

products, as well as those foods with 

variations of this original formulation. 

Such products would be prepared with 

less than 50 percent inspected and 

passed ready-to-eat meat or poultry, 

dispersed throughout the dough for a 

flavoring effect. (As a general matter, 

most products containing meat or 

poultry are composed of well below or 

well above 50 percent meat or poultry 

by weight.) 

Dried Poultry Soup Mixes 

Dried meat soup mixes, regardless of 

the amount of meat they contain, are 

currently under FDA jurisdiction based 

on a FSIS decision made decades ago, 

which is reflected in the FSIS Food 

Standards and Labeling Policy Book 

(2003). Dried poultry soup mixes, 

however, have historically been 

considered to be poultry products (FSIS 

Food Standards and Labeling Policy 

Book). This has been a point of disparity 

and confusion. Based on FSIS’

experience in reviewing product 

formulations, dried soup mixes with 

meat or poultry are composed of less 

than 50 percent inspected and passed 

dried/powdered meat/poultry (by 

weight). The meat and poultry 

components used to prepare these 

products are not in a form that is 

recognized as ‘‘meat’’ or ‘‘poultry’’ and 

are used at low levels for seasoning or 

flavoring effects. For this reason and for 

the sake of parity, the agencies are 

considering changing the jurisdiction of 

dried poultry soup mixes from FSIS to 

FDA. 

Flavor Bases/Flavors 

Flavor bases and reaction/process 

flavors are produced by rigorous heating 

(e.g., 100 °C or higher) and by chemical 

processes (e.g., hydrolysis/enzymolysis). 

Such products that are prepared with 

inspected and passed meat or poultry 

ingredients are in a powder, slurry, or 

paste form. They are used in other 

products for a flavoring effect, not for 

their contribution to the meat or poultry 

content of the food products. 

Furthermore, such products are 

typically sold for use within the food 

industry, not for use by household 

consumers. Therefore, the agencies are 

considering changing the jurisdiction of 

this category of products from FSIS to 

FDA. 

Pizzas With Meat or Poultry 

In 2003, FSIS eliminated the standard 

of identity for traditional pizzas with 

meat or poultry (68 FR 44859, July 31, 

2003). Thus, traditional pizzas 

composed of sauce, cheese, and 

inspected and passed meat or poultry 

toppings on a layered crust need only 

contain 2 percent meat or poultry by 

weight to be under FSIS jurisdiction. 

However, the base onto which toppings 

are placed represents the majority of the 

product, and meat or poultry 

ingredients may be among any number 

of toppings used for flavoring purposes. 

While the meat or poultry toppings 

provide flavoring to the finished food, 

they do not change the character of the 

food. Because non-meat/poultry pizzas 

have always been under FDA’s 

jurisdiction, and the meat or poultry 

ingredients are generally used to 

provide flavor, the agencies are 

considering changing the jurisdiction of 

these products from FSIS to FDA. 

Salad Dressings Made With Less Than 

50 Percent Meat or Poultry 

Over the years, FSIS has made 

jurisdictional decisions that salad 

dressing products made with cooked 

meat ingredients (e.g., cooked bacon) are 

not meat products. The basis for the 

decisions was that such products were 

consistent with the standards of identity 

for ‘‘dressings’’ in 21 CFR Part 169, 

Food Dressings and Flavorings. 

Although the standards do not list meat 

ingredients as optional ingredients, the 

meat ingredients were not considered to 

characterize the dressings as meat 

products, nor were they considered to 

characterize non-standardized 

dressings, such as vinaigrettes. As 

optional ingredients, the meat or poultry 

ingredients are intended to provide 

flavor and do not contribute to the 

characterization of the products as salad 

dressings. There has, however, been 

occasional confusion regarding under 

which agency would regulate the 

product. The agencies therefore are 

contemplating making clear that salad 

dressings that contain less than 50 

percent inspected and passed, ready-toeat meat or poultry ingredients by 

weight (e.g., cooked bacon), are not meat 

or poultry products and are under FDA 

jurisdiction. 

The agencies recognize that these 

jurisdictional changes would affect 

firms and establishments, as well as the 

agencies themselves. It is unlikely that, 

in most cases, affected firms or 

establishments would have to overhaul 

production facilities or processing 

operations, significantly alter marketing 

approaches, or change product 

formulations to take actions to meet the 

regulatory requirements of one or the 

other agency. It is likely, however, that 

with the suggested changes in 

jurisdiction, there will be additional 

administrative, inspection, and labeling 

requirements. For example, firms 

moving to FSIS jurisdiction would need 

to: receive grants of inspection; develop 

and implement hazard analysis and 

critical control point (HACCP) plans, 

sanitation standard operating 

procedures (SSOPs), and pathogen 

control and other laboratory testing 

procedures; develop and implement 

systems of recordkeeping; and obtain 

product label approvals. 

II. Public Meeting 

FSIS and FDA are holding this public 

meeting in order to gain public input on 

the ideas set out in this notice and on 

the impact of the changes discussed 

herein. In order to benefit from this 

public meeting, the agencies are seeking 

input on a number of questions, 

including: 

• Is the approach that is suggested by 

the agencies a reasonable one? If not, 

why not? 

• Are there other food products or 

product categories that have been the 

subject of historical regulatory 

jurisdictional decisions by FSIS, which 

were based on a consumer perception 

factor, that should be considered by the 

agencies? 

• How many firms or establishments 

would be affected for each product and 

product category? What is the volume of 

production for each product or product 

category? 

• Would there be modifications in 

equipment, facility design, labeling, 

recordkeeping, or processing and 

reporting responsibilities that are 

needed in order for current operations 

to continue making the products that are 

the subject of the suggested changes, 

and what are they? 

• What would the administrative, 

operational, marketing, and labeling 

costs be associated with changes in 

product jurisdiction? 

• What would be a reasonable process 

and time frame within which to 

implement any changes in jurisdiction? 

• What would be consumers’ views of 

the subject products under the 

suggested approach? More particularly, 

what effect would changing regulatory 

jurisdiction have on consumers’

perceptions of the subject products? For 

example, what would consumers’

reaction be to the fact that dried chicken 

soup mix is regulated by FDA? 

• What effects would there be, if any, 

on the way the subject products are 

marketed? 

The agencies seek as much 

information as possible about the 

impact of any changes in jurisdiction. 

III. Registration 

Please submit your registration 

information (including name, title, firm 

name, address, telephone number, eVerDate Aug<31>2005 16:38 Nov 04, 2005 Jkt 208001 PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 E:\FR\FM\07NON1.SGM 07NON1
67494 Federal Register / Vol. 70, No. 214 / Monday, November 7, 2005 / Notices 

mail address, and fax number) at least 

5 workdays before the public meeting 

date. We encourage you to register 

online at http://www.cfsan.fda.gov/- 

comm/register.html. or to fax your 

registration directly to Marion V. Allen 

at 301–436–2605. We will accept 

registrations onsite. Space is limited and 

registration will be closed when 

maximum seating capacity is reached 

(250 people). If you need special 

accommodations due to a disability, 

please notify Marion V. Allen at least 7 

workdays in advance. 

We encourage individuals or firms 

with relevant data or information to 

present such information at the meeting 

or in written comments to the record. If 

you would like to make oral comments 

at the meeting, please specify your 

interest in speaking when you register. 

The amount of time for each oral 

presentation will be limited to 5 

minutes. 

IV. Transcripts 

A transcript will be made of the 

proceedings of the meeting. You may 

request a copy of the meeting transcript 

in writing approximately 30 working 

days after the public meeting at a cost 

of 10 cents per page from: 

FDA: FDA’s Freedom of Information 

Office (HFI–35), Food and Drug 

Administration, 5600 Fishers Lane, rm. 

12A–16, Rockville, MD 20857; or 

FSIS: FSIS, Freedom of Information 

Office, USDA, 1400 Independence Ave., 

SW., Room 1140 South Building, 

Washington, DC 20250. 

The transcript of the public meeting 

and all comments submitted will be 

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ADDRESSES for locations and hours). 

V. Comments 

In addition to presenting oral 

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interested persons may submit written 

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this meeting and Federal Register notice 

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FSIS: Submit comments by any of the 

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Comments are to be identified by the 

Docket No. 05–013N. All comments 

submitted in response to this notice will 

be available for public inspection in the 

Agencies’ Docket offices and web sites. 

[See ADDRESSES section for location and 

hours]. 

Additional Public Notification 

Public awareness of all segments of 

rulemaking and policy development is 

important. Consequently, in an effort to 

ensure that the public and in particular 

minorities, women, and persons with 

disabilities, are aware of this notice, 

FSIS will announce it on-line through 

the FSIS Web page located at http:// 

www.fsis.usda.gov/regulations/ 

2005_Notices_Index/index.asp. 

FSIS also will make copies of this 

Federal Register publication available 

through the FSIS Constituent Update, 

which is used to provide information 

regarding FSIS policies, procedures, 

regulations, Federal Register notices, 

FSIS public meetings, recalls, and other 

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and stakeholders. The update is 

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subscription service consisting of 

industry, trade, and farm groups, 

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Through Listserv and the web page, 

FSIS is able to provide information to a 

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In addition, FSIS offers an e-mail 

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Done in Washington DC on: November 2, 

2005. 

Jeffrey E. Shuren, 

Assistant Commissioner for Policy, Food and 

Drug Administration. 

Sean Altekruse, 

Deputy Executive Associate Administrator, 

OPPED, Food Safety Inspection Service. 

[FR Doc. 05–22123 Filed 11–3–05; 8:45 am] 

BILLING CODE 3410–DM–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; Women’s Health Initiative 

Observational Study 

Summary: In compliance with the 

requirement of Section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, Office 

of the Director, the National Heart, 

Lung, and Blood Institute (NHLBI), the 

National Institutes of Health (NIH) will 

publish periodic summaries of proposed 

projects to be submitted to the Office of 

Management and Budget (OMB) for 

review and approval. 

Proposed Collection: Title: Women’s 

Health Initiative (WHI) Observational 

Study. Type of Information Collection 

Request: Revision OMB #0925–0414 

Exp: 04/06. Need for Use of Information 

Collection: This study will be used by 

the NIH to evaluate risk factors for 

chronic disease among older women by 

developing and following a large cohort 

of postmenopausal women and relating 

subsequent disease development to 

baseline assessments of historical, 

physical, psychosocial, and physiologic 

characteristics. In addition, the 

observational study will complement 

the clinical trial (which has received 

clinical exemption) and provide 

additional information on the common 

causes of frailty, disability and death for 

postmenopausal women, namely, 

coronary heart disease, breast and 

colorectal cancer, and osteoporotic 

fractures. Continuation of follow-up 

years for ascertainment of medical 

history update forms will provide 

essential data for outcomes assessment 

for this population of aging women. 

Frequency of Response: On occasion. 

Affected Public: Individuals and 

physicians. Type of Respondents: 

Women, next-of-kin, and physician’s 

office staff. The annual reporting burden 

is as follows: 

Type of respondents 

Estimated 

number of 

respondents 

Estimated 

number of responses per 

respondent 

Average burden 

hours per 

response 

Estimated total 

annual burden 

hours requested 

OS Participants ............................................................................................ 85,786 1 .21 18,195