Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements, 41818-41819 [E6-11642]

Download as PDF 41818 Federal Register / Vol. 71, No. 141 / Monday, July 24, 2006 / Notices in the final rule is now covered in other OMB-approved information collection packages for FDA. However, parties may continue to seek an exemption from the bar code requirement under certain, limited circumstances. Section 201.25(d) (21 CFR 201.25(d)) requires submission of a written request for an exemption and describes the contents of such requests. Based on the number of exemption requests submitted during 2004 and 2005, we estimate that approximately 2 waiver requests may be submitted annually, and that each exemption request will require 24 hours to complete. This would result in an annual reporting burden of 48 hours. TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 21 CFR Section No. of Responses Per Respondent No. of Respondents 201.25(d) 2 Total Annual Responses 1 Hours per Response 2 24 Total are no capital costs or operating and maintenance costs associated with this collection of information. Dated: July 17, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–11641 Filed 7–21–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N–0277] Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements AGENCY: Food and Drug Administration, HHS. sroberts on PROD1PC70 with NOTICES 48 48 1There ACTION: Total Hours 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 information collection provisions of the regulation requiring manufacturers, packers, and distributors of dietary supplements to notify FDA that they are marketing a dietary supplement product that bears on its label or in its labeling a statement provided for in the Federal Food, Drug, and Cosmetic Act (the act). DATES: Submit written or electronic comments on the collection of information by September 22, 2006. ADDRESSES: Submit electronic comments on the collection of information to: https://www.fda.gov/ VerDate Aug<31>2005 17:54 Jul 21, 2006 Jkt 208001 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: Jonna Capezzuto, Office of Management Programs (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–4659. 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 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 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. Food Labeling; Notification Procedures for Statements on Dietary Supplements—21 CFR 101.93 (OMB Control Number 0910–0331)—Extension Section 403(r)(6) of the act (21 U.S.C 343(r)(6)) requires that the agency 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 the agency 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: (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. The agency 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. E:\FR\FM\24JYN1.SGM 24JYN1 41819 Federal Register / Vol. 71, No. 141 / Monday, July 24, 2006 / Notices Description of Respondents: Businesses or other for-profit organizations. FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents 21 CFR Section 101.93 2,500 1There Dated: July 17, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–11642 Filed 7–21–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N–0278] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Continuous Marketing Applications: Pilot 2—Scientific Feedback and Interactions During Development of Fast Track Products Under the Prescription Drug User Fee Act AGENCY: Food and Drug Administration, HHS. sroberts on PROD1PC70 with NOTICES Total Annual Responses 1 Hours per Respondent 2,500 Total Hours .75 1,875 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 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. The agency 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 the agency in the preceding 12 months. ACTION: Annual Frequency per Response 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 VerDate Aug<31>2005 17:54 Jul 21, 2006 Jkt 208001 notice. This notice solicits comments on the information collection contained in the guidance for industry on Continuous Marketing Applications: Pilot 2— Scientific Feedback and Interactions During Development of Fast Track Products Under the Prescription Drug User Fee Act. DATES: Submit written or electronic comments on the collection of information by September 22, 2006. ADDRESSES: Submit electronic comments on the collection of information to: https://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: Elizabeth Berbakos, Office of Management Programs (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 1482. 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 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 SUPPLEMENTARY INFORMATION: PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 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. Guidance for Industry on Continuous Marketing Applications: Pilot 2— Scientific Feedback and Interactions During Development of Fast Track Products Under the Prescription Drug User Fee Act—(OMB Control Number 0910–0518)— Extension FDA is requesting OMB approval under the PRA (44 U.S.C. 3507) for the reporting and recordkeeping requirements contained in the guidance for industry entitled ‘‘Continuous Marketing Applications (CMA): Pilot 2—Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA.’’ This guidance discusses how the agency will implement a pilot program for frequent scientific feedback and interactions between FDA and applicants during the investigational phase of the development of certain Fast Track drug and biological products. Applicants are asked to apply to participate in the Pilot 2 program. In conjunction with the June 2002 reauthorization of the Prescription Drug User Fee Act of 1992 (PDUFA), FDA agreed to meet specific performance goals (PDUFA Goals). The PDUFA Goals include two pilot programs to explore the CMA concept. The CMA concept builds on the current practice of interaction between FDA and applicants during drug development and application review and proposes opportunities for improvement. Under E:\FR\FM\24JYN1.SGM 24JYN1

Agencies

[Federal Register Volume 71, Number 141 (Monday, July 24, 2006)]
[Notices]
[Pages 41818-41819]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-11642]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0277]


Agency Information Collection Activities; Proposed Collection; 
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 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 information collection 
provisions of the regulation requiring manufacturers, packers, and 
distributors of dietary supplements to notify FDA that they are 
marketing a dietary supplement product that bears on its label or in 
its labeling a statement provided for in the Federal Food, Drug, and 
Cosmetic Act (the act).

DATES:  Submit written or electronic comments on the collection of 
information by September 22, 2006.

ADDRESSES:  Submit electronic comments on the collection of information 
to: https://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: Jonna Capezzuto, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-4659.

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.

Food Labeling; Notification Procedures for Statements on Dietary 
Supplements--21 CFR 101.93 (OMB Control Number 0910-0331)--Extension

    Section 403(r)(6) of the act (21 U.S.C 343(r)(6)) requires that the 
agency 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 the agency 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: (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.
    The agency 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.

[[Page 41819]]

    Description of Respondents: Businesses or other for-profit 
organizations.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual Frequency       Total Annual        Hours per
                    21 CFR Section                         Respondents         per Response          Responses          Respondent        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.

    The agency 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. The 
agency 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 
the agency in the preceding 12 months.

    Dated: July 17, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-11642 Filed 7-21-06; 8:45 am]
BILLING CODE 4160-01-S

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