6444 Federal Register / Vol. 70, No. 24 / Monday, February 7, 2005 / Notices 

TRANS # Acquiring Acquired Entities 

20050489 ......................... Highland Capital Partners VI ............. Michael Mann .................................... Rare Domains.com, LLC. 

Rare Names, LLC. 

Transactions Granted Early Termination—01/21/2005

20050487 ......................... Cofra Holding AG .............................. Aaron D. Spencer .............................. Uno Restaurant Holdings Corporation. 

FOR FURTHER INFORMATION CONTACT:

Sandra M. Peay, Contact Representative, 

or Renee Hallman, Case Management 

Assistant. 

Federal Trade Commission, Premerger 

Notification Office, Bureau of 

Competition, Room H–303, Washington, 

DC 20580, (202) 326–3100.

By direction of the Commission. 

Donald S. Clark, 

Secretary.

[FR Doc. 05–2276 Filed 2–4–05; 8:45 am] 

BILLING CODE 6750–01–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N–0031]

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Premarket 

Notification for a New Dietary 

Ingredient

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the procedure by which a manufacturer 

or distributor of dietary supplements or 

of a new dietary ingredient is to submit 

information to FDA upon which it has 

based its conclusion that a dietary 

supplement containing a new dietary 

ingredient will reasonably be expected 

to be safe.

DATES: Submit written or electronic 

comments on the collection of 

information by April 8, 2005.

ADDRESSES: Submit electronic 

comments on the collection of 

information to: http://www.fda.gov/

dockets/ecomments. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane., rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document.

FOR FURTHER INFORMATION CONTACT:

Peggy Robbins, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1223.

SUPPLEMENTARY INFORMATION: 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, 

including each proposed extension of an 

existing 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.

Premarket Notification for a New 

Dietary Ingredient—21 CFR 190.6 

(OMB Control Number 0910–0330)—

Extension

Section 413(a) of the Federal Food, 

Drug, and Cosmetic Act (the act) (21 

U.S.C. 350b(a)) provides that a 

manufacturer or distributor of dietary 

supplements or of a new dietary 

ingredient is to submit information to 

FDA (as delegate for the Secretary of 

Health and Human Services) upon 

which it has based its conclusion that a 

dietary supplement containing a new 

dietary ingredient will reasonably be 

expected to be safe at least 75 days 

before the introduction or delivery for 

introduction into interstate commerce of 

a dietary supplement that contains a 

new dietary ingredient. FDA’s 

regulations at part 190, subpart B (21 

CFR part 190, subpart B) implement 

these statutory provisions. Section 

190.6(a) requires each manufacturer or 

distributor of a dietary supplement 

containing a new dietary ingredient, or 

of a new dietary ingredient, to submit to 

the Office of Nutritional Products, 

Labeling, and Dietary Supplements 

notification of the basis for their 

conclusion that said supplement or 

ingredient will reasonably be expected 

to be safe. Section 190.6(b) requires that 

the notification include the following: 

(1) The complete name and address of 

the manufacturer or distributor, (2) the 

name of the new dietary ingredient, (3) 

a description of the dietary supplements 

that contain the new dietary ingredient, 

and (4) the history of use or other 

evidence of safety establishing that the 

dietary ingredient will reasonably be 

expected to be safe.

The notification requirements 

described previously are designed to 

enable FDA to monitor the introduction 

into the food supply of new dietary 

ingredients and dietary supplements 

that contain new dietary ingredients, in 

order to protect consumers from unsafe 

dietary supplements. FDA uses the 

information collected under these 

regulations to help ensure that a 

manufacturer or distributor of a dietary 

Federal Register / Vol. 70, No. 24 / Monday, February 7, 2005 / Notices 6445

supplement containing a new dietary ingredient is in full compliance with the 

act.

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of Respondents Annual Frequency 

per Response 

Total Annual Responses Hours per Response Total Hours 

190.6 71 1 71 20 1,420

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

The agency believes that there will be 

minimal burden on the industry to 

generate data to meet the requirements 

of the premarket notification program 

because the agency is requesting only 

that information that the manufacturer 

or distributor should already have 

developed to satisfy itself that a dietary 

supplement containing a new dietary 

ingredient is in full compliance with the 

act. However, the agency estimates that 

extracting and summarizing the relevant 

information from the company’s files, 

and presenting it in a format that will 

meet the requirements of section 413 of 

the act will require a burden of 

approximately 20 hours of work per 

submission.

This estimate is based on the annual 

average number of premarket 

notifications FDA received during the 

last 3 years (i.e., 2002 to 2004), which 

was 47. Forty-seven represents 24 more 

notifications than the agency received as 

an annual average during the previous 

3-year period (i.e., 1999 to 2001). 

Therefore, FDA anticipates a similar 

upward trend will be seen in the annual 

average number of notifications the 

agency receives during 2005 to 2007, 

which is estimated to be 71.

Dated: January 28, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 05–2207 Filed 2–4–05; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N–0093]

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Registration of Producers of Drugs 

and Listing of Drugs in Commercial 

Distribution

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Registration of Producers of Drugs and 

Listing of Drugs in Commercial 

Distribution’’ has been approved by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995.

FOR FURTHER INFORMATION CONTACT:

Karen Nelson, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1482.

SUPPLEMENTARY INFORMATION: In the 

Federal Register of July 19, 2004 (69 FR 

42999), the agency announced that the 

proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

agency may not conduct or sponsor, and 

a person is not required to respond to, 

a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0045. The 

approval expires on December 31, 2007. 

A copy of the supporting statement for 

this information collection is available 

on the Internet at http://www.fda.gov/

ohrms/dockets.

Dated: January 28, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 05–2296 Filed 2–4–05; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N–0032]

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Food Canning 

Establishment Registration, Process 

Filing, and Recordkeeping for Acidified 

Foods and Thermally Processed LowAcid Foods in Hermetically Sealed 

Containers

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

reporting and recordkeeping 

requirements for firms that process 

acidified foods and thermally processed 

low-acid foods in hermetically sealed 

containers.

DATES: Submit written or electronic 

comments on the collection of 

information by April 8, 2005.

ADDRESSES: Submit written comments 

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. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document.

FOR FURTHER INFORMATION CONTACT:

Peggy Robbins, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1223.

SUPPLEMENTARY INFORMATION: 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, 

including each proposed extension of an 

existing collection of information,