Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements, 69569-69570 [E6-20307]

Download as PDF 69569 Federal Register / Vol. 71, No. 231 / Friday, December 1, 2006 / Notices Estimated Total Annual Burden Hours: 864. In compliance with the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comments on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. E-mail: infocollection.acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Dated: November 28, 2006. Robert Sargis, Reports Clearance Officer. [FR Doc. 06–9487 Filed 11–30–06; 8:45 am] BILLING CODE 4184–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request Proposed Projects Title: National Directory of New Hires. OMB No.: 0970–0166. Description: Public Law 104–193, the ‘‘Personal Responsibility and Work Opportunity Reconciliation Act of 1996,’’ requires the Office of Child Support Enforcement (OCSE) to operate a National Directory of New Hires (NDNH) to improve the ability of State child support enforcement agencies to locate noncustodial parents and collect child support across State lines. The law requires employers to report newly hired employees to States. States are then required to periodically transmit new hire data received from employers to the NDNH, and to transmit wage and unemployment compensation claims data to the NDNH on a quarterly basis. Federal agencies are required to report new hires and quarterly wage data directly to the NDNH. All data is transmitted to the NDNH electronically. Respondents: Employers, State Child Support Enforcement Agencies, State Workforce Agencies, Federal Agencies. ANNUAL BURDEN ESTIMATES: Number of respondents Instrument rmajette on PROD1PC67 with NOTICES1 New Hire: Employers Reporting Manually ..................................................... New Hire: Employers Reporting Electronically .............................................. New Hire: States ............................................................................................ Quarterly Wage & Unemployment Compensation ........................................ Multistate Employers’ Notification Form ........................................................ Estimated Total Annual Burden Hours: 760,828. In compliance with the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. E-mail address: infocollection@acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including VerDate Aug<31>2005 13:50 Nov 30, 2006 Jkt 211001 5,166,000 1,134,000 54 54 2,808 Number of responses per respondent Average burden hours per response 3.484 33.272 83.333 8 1 .025 .00028 66.7 .033 .050 Total burden hours whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: November 28, 2006. Robert Sargis, Reports Clearance Officer. [FR Doc. 06–9488 Filed 11–30–06; 8:45 am] ACTION: 449,959 10,565 300,150 14 140 BILLING CODE 4184–01–M PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 Food and Drug Administration [Docket No. 2006N–0277] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements AGENCY: Food and Drug Administration, HHS. 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 January 2, 2007. E:\FR\FM\01DEN1.SGM 01DEN1 69570 Federal Register / Vol. 71, No. 231 / Friday, December 1, 2006 / Notices 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: 202–395–6974. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 4659. 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. ADDRESSES: Food Labeling; Notification Procedures for Statements on Dietary Supplements—(OMB Control Number 0910–0331)—Extension Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C 343(r)(6)) requires that FDA be notified by manufacturers, packers, and distributors of dietary supplements that they are marketing a dietary supplement product that bears on its label or in its labeling a statement provided for in section 403(r)(6) of the act. Section 403(r)(6) of the act requires that FDA be notified, with a submission about such statements, no later than 30 days after the first marketing of the dietary supplement. Information that is required in the submission includes the following: (1) The name and address of the manufacturer, packer, or distributor of the dietary supplement product; (2) the text of the statement that is being made; (3) the name of the dietary ingredient or supplement that is the subject of the statement; (4) the name of the dietary supplement (including the brand name); and (5) a signature of a responsible individual who can certify the accuracy of the information presented, and who must certify that the information contained in the notice is complete and accurate, and that the notifying firm has substantiation that the statement is truthful and not misleading. FDA established § 101.93 (21 CFR 101.93) as the procedural regulation for this program. Section 101.93 provides details of the procedures associated with the submission and identifies the information that must be included in order to meet the requirements of section 403 of the act. Description of Respondents: Businesses or other for-profit organizations. In the Federal Register of July 24, 2006 (71 FR 41818), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received before the comment period closed. TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 21 CFR Section No. of respondents 101.93 1There Annual frequency per response 2,500 1 Hours per response 2,500 Total hours .75 1,875 are no capital costs or operating and maintenance costs associated with this collection of information. FDA believes that there will be minimal burden on the industry to generate information to meet the requirements of section 403 of the act in submitting information regarding section 403(r)(6) of the act statements on labels or in labeling of dietary supplements. FDA is requesting only information that is immediately available to the manufacturer, packer, or distributor of the dietary supplement that bears such a statement on its label or in its labeling. This estimate is based on the average number of notification submissions received by FDA in the preceding 12 months. Dated: November 21, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–20307 Filed 12–01–06; 8:45 am] BILLING CODE 4160–01–S rmajette on PROD1PC67 with NOTICES1 Total annual responses VerDate Aug<31>2005 13:50 Nov 30, 2006 Jkt 211001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Equal Employment Opportunity Staff (GFJ1) Indian Health Service (1) Advises the Area Director and other key management officials in the execution of their IHS responsibilities; (2) provides program direction and leadership for the Area EEO program and procedures; and (3) ensures the elimination of discrimination practices in employment, promotion, training, treatment of applicants, and employees, because of race, color, religion, national origin, sex, age, and handicapping conditions. Navajo Area Indian Health Service (GFJ); Organization, Functions, and Delegations of Authority Office of the Area Director (GFJ1) (1) Plans, develops and directs the Area Program within the framework of Indian Health Service (IHS) policy in pursuit of the IHS mission; (2) delivers and ensures the delivery of high quality comprehensive health services; (3) coordinates the IHS activities and resources internally and externally with those of other governmental and nongovernmental programs; (4) promotes optimum utilization of health care services through management and delivery of services to American Indians and Alaska Natives; (5) encourages the full application of the principles of Indian preference and Equal Employment Opportunity (EEO); and (6) provides Indian Tribes and other Indian community groups with optional ways of participating in the Indian Health programs including an opportunity to participate in developing the mission, values and goals for the Navajo Area Indian Health Service (NAIHS). PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 Office of Administration and Management (GFJ2) (1) Plans, directs, and coordinates NAIHS activities in the areas of policy, internal controls reviews, financial management, personnel management, third-party reimbursements; contract health services (CHS) funds; contracts management, procurement, personal property accountability/management, and administrative services; (2) serves as the Navajo Area principal advisor on all Area organization and management policy activities; and (3) provides guidance and assistance to service units in the overall development, planning and implementation of administrative functions. E:\FR\FM\01DEN1.SGM 01DEN1

Agencies

[Federal Register Volume 71, Number 231 (Friday, December 1, 2006)]
[Notices]
[Pages 69569-69570]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-20307]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0277]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Food Labeling; 
Notification Procedures for Statements on Dietary Supplements

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 January 
2, 2007.

[[Page 69570]]


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: 202-395-6974.

FOR FURTHER INFORMATION CONTACT:  Jonna Capezzuto, Office of the Chief 
Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4659.

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.

Food Labeling; Notification Procedures for Statements on Dietary 
Supplements--(OMB Control Number 0910-0331)--Extension

    Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C 343(r)(6)) requires that FDA be notified by 
manufacturers, packers, and distributors of dietary supplements that 
they are marketing a dietary supplement product that bears on its label 
or in its labeling a statement provided for in section 403(r)(6) of the 
act. Section 403(r)(6) of the act requires that FDA be notified, with a 
submission about such statements, no later than 30 days after the first 
marketing of the dietary supplement. Information that is required in 
the submission includes the following: (1) The name and address of the 
manufacturer, packer, or distributor of the dietary supplement product; 
(2) the text of the statement that is being made; (3) the name of the 
dietary ingredient or supplement that is the subject of the statement; 
(4) the name of the dietary supplement (including the brand name); and 
(5) a signature of a responsible individual who can certify the 
accuracy of the information presented, and who must certify that the 
information contained in the notice is complete and accurate, and that 
the notifying firm has substantiation that the statement is truthful 
and not misleading.
    FDA established Sec.  101.93 (21 CFR 101.93) as the procedural 
regulation for this program. Section 101.93 provides details of the 
procedures associated with the submission and identifies the 
information that must be included in order to meet the requirements of 
section 403 of the act.
    Description of Respondents: Businesses or other for-profit 
organizations.
    In the Federal Register of July 24, 2006 (71 FR 41818), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received before the comment 
period closed.

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                   No. of         Annual frequency
               21 CFR Section                   respondents         per response        Total annual responses    Hours per response      Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
101.93                                                   2,500                     1                      2,500                   .75              1,875
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA believes that there will be minimal burden on the industry to 
generate information to meet the requirements of section 403 of the act 
in submitting information regarding section 403(r)(6) of the act 
statements on labels or in labeling of dietary supplements. FDA is 
requesting only information that is immediately available to the 
manufacturer, packer, or distributor of the dietary supplement that 
bears such a statement on its label or in its labeling. This estimate 
is based on the average number of notification submissions received by 
FDA in the preceding 12 months.

    Dated: November 21, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-20307 Filed 12-01-06; 8:45 am]
BILLING CODE 4160-01-S
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