Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products, 78974-78975 [2013-30880]

Download as PDF 78974 Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Notices efficiency of the review process. Although alternative approaches may be used, if these approaches satisfy the requirements of the applicable statutes and regulations. We are requesting the extension of OMB approval for the information collection provisions in the guidance. Description of Respondents: The likely respondents include businesses engaged in the manufacture or sale of food, food ingredients, and substances used in materials that come into contact with food. In the Federal Register of October 28, 2013 (78 FR 64218), FDA published a 60-day notice requesting public comment on the proposed collection of information. One comment was received. However, the comment was beyond the scope of the collection of information’s four topics that are being solicited. Therefore, it will not be discussed in this document. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Number of responses per respondent § 25.32(i) .............................................................................. § 25.32(o) ............................................................................. § 25.32(q) ............................................................................. 42 1 2 1 1 1 42 1 2 1 1 1 42 1 2 Total .............................................................................. ........................ ........................ ........................ ........................ 45 21 CFR Part 25; Environmental impact considerations tkelley on DSK3SPTVN1PROD with NOTICES 1 There Total annual responses Average burden per response Total hours are no capital costs or operating and maintenance costs associated with this collection of information. The above estimates for respondents and numbers of responses are based on the annualized numbers of petitions and notifications qualifying for § 25.32(i) and (q) that the Agency has received in the past 3 years. Please note that in the past 3 years, there have been no submissions that requested an action that would have been subject to the categorical exclusion in § 25.32(o). To avoid counting this burden as zero, we have estimated the burden for this categorical exclusion at one respondent making one submission a year for a total of one annual submission. To calculate the estimate for the hours per response values, we assumed that the information requested for each of these three categorical exclusions in this guidance is readily available to the submitter. For the information requested for the exclusion in § 25.32(i), we expect that submitter will need to gather information from appropriate persons in the submitter’s company and prepare this information for attachment to the claim for categorical exclusion. We believe that this effort should take no longer than 1 hour per submission. For the information requested for the exclusions in § 25.32(o) and (q), the submitters will almost always merely need to copy existing documentation and attach it to the claim for categorical exclusion. We believe that collecting this information should also take no longer than 1 hour per submission. Dated: December 20, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–30998 Filed 12–26–13; 8:45 am] BILLING CODE 4160–01–P VerDate Mar<15>2010 23:48 Dec 26, 2013 Jkt 232001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–1558] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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 request regarding the guidance for industry and FDA staff entitled ‘‘Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products.’’ DATES: Submit either electronic or written comments on the collection of information by February 25, 2014. ADDRESSES: Submit electronic comments on the collection of information to http:// www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets SUMMARY: PO 00000 Frm 00165 Fmt 4703 Sfmt 4703 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: FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, PRAStaff@fda.hhs.gov. 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 E:\FR\FM\27DEN1.SGM 27DEN1 Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Notices 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. Information Request Regarding Guidance for Industry and FDA Staff on Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products (OMB Control Number 0910–0673—Extension) On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act) (Pub. L. 111–31) into law. The Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding a new chapter granting FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health generally and 78975 to reduce tobacco use by minors. Section 905(j) of the FD&C Act (21 U.S.C. 387e(j)) authorizes FDA to establish the form for the submission of information related to substantial equivalence. In a Level 1 guidance document issued under the Good Guidances Practices regulation (21 CFR 10.115), FDA provides recommendations intended to assist persons submitting reports under section 905(j) of the FD&C Act and explains, among other things, FDA’s interpretation of the statutory sections related to substantial equivalence. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 FD&C act sections Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours 905(j)(1)(A)(i) and 910(a) ..................................................... 1,000 1 1,000 360 360,000 1 There are no capital costs or operating and maintenance costs associated with this collection of information. FDA has based these estimates on information it now has available from interactions with the industry, information related to other regulated products, and FDA’s expectations regarding the tobacco industry’s use of the section 905(j) pathway to market their products. Table 1 describes the annual reporting burden as a result of the implementation of the substantial equivalence requirements of sections 905(j) and 910(a) of the FD&C Act (21 U.S.C. 387j(a)). FDA estimates that it will receive 1,000 section 905(j) reports each year and that it will take a manufacturer approximately 360 hours to prepare a report of substantial equivalence for a new tobacco product. Therefore, FDA estimates the burden for submission of substantial equivalence information will be 360,000 hours. Dated: December 19, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–30880 Filed 12–26–13; 8:45 am] BILLING CODE 4160–01–P tkelley on DSK3SPTVN1PROD with NOTICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Notice of Publication of a Draft of the Revised Guidebook for the National Practitioner Data Bank Health Resources and Services Administration (HRSA), HHS. AGENCY: VerDate Mar<15>2010 23:48 Dec 26, 2013 Jkt 232001 ACTION: Notice of Publication of a Draft of the Revised Guidebook for the National Practitioner Data Bank. how to submit comments, visit the NPDB Web site at: http:// www.npdb.hrsa.gov/news/news.jsp. The National Practitioner Data Bank (NPDB) announces the release of a draft of the revised user Guidebook. The public is able to request a copy of the draft of the revised Guidebook and submit comments to the NPDB by the deadline below. The revised Guidebook includes expanded and improved reporting and querying examples; useful tables explaining Data Bank policies; and live links to statutes, regulations, and the Web site. The NPDB is a confidential information clearinghouse created by Congress intended to facilitate a comprehensive review of the professional credentials of health care practitioners, health care entities, providers, and suppliers. The Guidebook is a policy manual that serves as an essential reference for Data Bank users to clarify legislative and regulatory requirements through the use of reporting and querying examples, explanations, definitions, and frequently asked questions (FAQs). The new Guidebook incorporates legislative and regulatory changes adopted since its last edition, including the merger of the NPDB with the Healthcare Integrity and Protection Data Bank. Once the comments have been reviewed, a final version of the revised Guidebook will be made available and will replace previous Guidebooks. For information on how to request a PDF copy of the draft Guidebook and instructions on DATES: SUMMARY: PO 00000 Frm 00166 Fmt 4703 Sfmt 9990 Comments may be submitted through January 10, 2014. The comment period may be extended if needed. Information on any extensions of the review period will be posted on the Web site here: http://www.npdb.hrsa.gov/ news/news.jsp. FOR FURTHER INFORMATION CONTACT: Ernia P. Hughes, MBA, Acting Director of the Division of Practitioner Data Banks at: NPDBPolicy@hrsa.gov or 301– 443–2300. When submitting remarks, the NPDB requests that commenters: • Reference the page number(s) each comment addresses; and • Ensure comments are specific and relate to the clarity of the NPDB Guidebook’s content, as regulatory or statutory concerns are beyond the scope of this comment process. Comments should be limited to content-based feedback that seeks to improve the examples and FAQs, clarify definitions, and eliminate ambiguity in the text. Comments that are not specific to content clarity and found beyond the scope of this review will not be addressed in this process. SUPPLEMENTARY INFORMATION: Dated: December 19, 2013. Mary K. Wakefield, Administrator. [FR Doc. 2013–31119 Filed 12–26–13; 8:45 am] BILLING CODE 4165–15–P E:\FR\FM\27DEN1.SGM 27DEN1

Agencies

[Federal Register Volume 78, Number 249 (Friday, December 27, 2013)]
[Notices]
[Pages 78974-78975]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-30880]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1558]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Guidance for Industry and Food and Drug Administration 
Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence 
for Tobacco Products

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 request 
regarding the guidance for industry and FDA staff entitled ``Section 
905(j) Reports: Demonstrating Substantial Equivalence for Tobacco 
Products.''

DATES: Submit either electronic or written comments on the collection 
of information by February 25, 2014.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, PRAStaff@fda.hhs.gov.

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

[[Page 78975]]

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.

Information Request Regarding Guidance for Industry and FDA Staff on 
Section 905(j) Reports: Demonstrating Substantial Equivalence for 
Tobacco Products (OMB Control Number 0910-0673--Extension)

    On June 22, 2009, the President signed the Family Smoking 
Prevention and Tobacco Control Act (the Tobacco Control Act) (Pub. L. 
111-31) into law. The Tobacco Control Act amended the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) by adding a new chapter granting FDA 
authority to regulate the manufacture, marketing, and distribution of 
tobacco products to protect the public health generally and to reduce 
tobacco use by minors. Section 905(j) of the FD&C Act (21 U.S.C. 
387e(j)) authorizes FDA to establish the form for the submission of 
information related to substantial equivalence. In a Level 1 guidance 
document issued under the Good Guidances Practices regulation (21 CFR 
10.115), FDA provides recommendations intended to assist persons 
submitting reports under section 905(j) of the FD&C Act and explains, 
among other things, FDA's interpretation of the statutory sections 
related to substantial equivalence.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                         FD&C act sections                              Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
905(j)(1)(A)(i) and 910(a).........................................           1,000                1            1,000              360          360,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA has based these estimates on information it now has available 
from interactions with the industry, information related to other 
regulated products, and FDA's expectations regarding the tobacco 
industry's use of the section 905(j) pathway to market their products. 
Table 1 describes the annual reporting burden as a result of the 
implementation of the substantial equivalence requirements of sections 
905(j) and 910(a) of the FD&C Act (21 U.S.C. 387j(a)). FDA estimates 
that it will receive 1,000 section 905(j) reports each year and that it 
will take a manufacturer approximately 360 hours to prepare a report of 
substantial equivalence for a new tobacco product. Therefore, FDA 
estimates the burden for submission of substantial equivalence 
information will be 360,000 hours.

    Dated: December 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-30880 Filed 12-26-13; 8:45 am]
BILLING CODE 4160-01-P