Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry; How To Prepare a Pre-Request for Designation, 32825-32826 [2017-15005]

Download as PDF sradovich on DSK3GMQ082PROD with NOTICES Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices purportedly ‘‘VOC-free’’ paints. ‘‘VOC’’ is the abbreviation for volatile organic compounds. VOC-free includes claims such as ‘‘zero VOCs,’’ ‘‘0 VOCs,’’ and ‘‘No VOCs.’’ According to the FTC complaint, respondent made unsubstantiated representations that its paints: (1) Are VOC-free; (2) are VOCfree during or immediately after painting; (3) will not emit any chemical or substance, including VOCs, that causes material harm to consumers, including sensitive populations such as children; and (4) will not emit any chemical or substance, including VOCs, during or immediately after painting, that causes material harm to consumers, including sensitive populations such as children. The FTC further alleges that respondent provided independent retailers with promotional materials containing the same claims it made to consumers. Thus, the complaint alleges that respondent engaged in deceptive practices in violation of Section 5(a) of the FTC Act. The proposed consent order contains three provisions designed to prevent respondent from engaging in similar acts and practices in the future. Part I prohibits emission-free and VOC-free claims unless both content and emissions are actually zero or at trace levels. The orders define ‘‘emission’’ to include all emissions (not just VOCs that cause smog). This definition reflects the Commission’s Enforcement Policy Statement and consumer expectations: consumers are likely concerned about the potential health effects from exposure to chemical emissions found in indoor air, not just VOCs that affect outdoor air quality. The order defines ‘‘trace level of emission’’ to mean (1) no intentionally added VOC, (2) emission of the covered product does not cause material harm that consumers typically associate with emission, including harm to the environment or human health, and (3) emission of the covered product does not result in more than harmless concentrations of and compound higher than would be found under normal conditions in the typical residential home without interior architectural coating. Part II prohibits misleading representations regarding emission, VOC levels, odor, and any general environmental and health benefit of paints. The order requires competent and reliable scientific evidence to substantiate these representations. Part IV prohibits respondent from providing third parties with the means and instrumentalities to make false, unsubstantiated, or otherwise misleading representations of material fact regarding paints, including any VerDate Sep<11>2014 17:47 Jul 17, 2017 Jkt 241001 representation prohibited by Parts I or II. To correct existing unsubstantiated zero emission and VOC claims, Part III requires the respondent to send letters to its dealers and distributors, instructing them to put stickers on paint cans to obscure allegedly unsubstantiated emission and VOC claims. Parts V through IX are reporting and compliance provisions. Part V mandates that respondent acknowledge receipt of the order, distribute the order to certain employees and agents, and secure acknowledgments from recipients of the order. Part VI requires that respondent submit compliance reports to the FTC within sixty (60) days of the order’s issuance and submit additional reports when certain events occur. Part VII requires that respondent must create and retain certain records for five (5) years. Part VIII provides for the FTC’s continued compliance monitoring of respondent’s activity during the order’s effective dates. Part IX is a provision ‘‘sunsetting’’ the order after twenty (20) years, with certain exceptions. If the Commission finalizes the agreement’s proposed order, it plans to propose harmonizing with this order the consent orders issued in the PPG Architectural Finishes, Inc. (Docket No. C–4385) and The Sherwin-Williams Company (Docket No. C–4386) matters. Specifically, the Commission plans to issue orders to show cause why those matters should not be modified pursuant to Section 3.72(b) of the Commission Rules of Practice, 16 CFR 3.72(b). The purpose of the analysis is to aid public comment on the proposed order. It is not intended to constitute an official interpretation of the proposed order or to modify its terms in any way. By direction of the Commission. Donald S. Clark, Secretary. [FR Doc. 2017–14973 Filed 7–17–17; 8:45 am] BILLING CODE 6750–01–P PO 00000 32825 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–D–0040] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry; How To Prepare a PreRequest for Designation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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 August 17, 2017. 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: 202–395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910—NEW and title ‘‘Draft Guidance for Industry; How to Prepare a Pre-Request for Designation (Pre-RFD).’’ Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–8867, PRAStaff@ fda.hhs.gov. SUMMARY: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: Draft Guidance for Industry; How To Prepare a Pre-Request for Designation (Pre-RFD) OMB Control Number 0910—NEW Since its establishment on December 24, 2002, the FDA Office of Combination Products (OCP) has served as a resource for sponsors at various stages of development of their product. Sponsors often seek OCP feedback on whether their medical product will be regulated as a drug, a device, a biologic, Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\18JYN1.SGM 18JYN1 32826 Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices or a combination product, and which FDA medical product Agency Center (Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, or Center for Devices and Radiological Health) will regulate it, if it is a non-combination product, or will have the primary jurisdiction for the premarket review and regulation of the product, if it is a combination product. There are two ways that a sponsor can receive such feedback from OCP. One option is to submit an RFD to receive a formal, binding determination for the sponsor’s product with respect to classification and/or center assignment that may be changed under conditions specified in section 563 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–2) and 21 CFR 3.9 in the regulations. The RFD process is codified in 21 CFR part 3, and OCP has issued a guidance about this process (see ‘‘How to Write a Request for Designation’’ at https://www.fda.gov/ RegulatoryInformation/Guidances/ ucm126053.htm). A second more flexible option is for a sponsor to submit an inquiry to OCP to receive a preliminary jurisdictional assessment, which is not binding. Many sponsors seek to utilize the flexibility of more approachable ways to interact with OCP and the medical product Agency Centers to obtain feedback from the Agency before submitting a marketing application to the Agency. Over time, these informal methods of obtaining feedback have become increasingly customary with sponsors, and for some, even preferable to the formal RFD process. Accordingly, FDA is enhancing the transparency and consistency of this process, which will now be called the ‘‘Pre-Request for Designation (Pre-RFD) Program.’’ This draft guidance describes this structured process with clear recommendations for sponsors wishing to submit Pre-RFDs. It also provides the process for review of Pre-RFDs by FDA staff, the general timeframes for sponsors to receive feedback from OCP, and the process for scheduling teleconferences and meetings in relation to a Pre-RFD. This draft guidance describes how to prepare a Pre-RFD. The guidance provides recommendations regarding the information that should be submitted in a Pre-RFD request and procedures that should be followed for meetings or conference calls between OCP, the Centers, and industry representatives or sponsors. The proposed collections of information are necessary to allow the Agency to receive Pre-RFD requests in order to implement this voluntary submission program. In the Federal Register of January 13, 2017 (82 FR 4351), FDA published a 60day notice requesting public comment on the proposed collection of information. Although two comments were received, they were not responsive to the four collection of information topics solicited and therefore will not be discussed. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Activity Number of responses per respondent Total annual responses Average burden per response Total hours Pre-RFD Submissions ............................................................................. Pre-RFD Meetings ................................................................................... 136 136 1 1 136 136 12 1 1,632 136 Total .................................................................................................. .................... .................... .................... .................... 1,768 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: July 12, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–15005 Filed 7–17–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration sradovich on DSK3GMQ082PROD with NOTICES [Docket No. FDA–2010–N–0600] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Drug User Fee Cover Sheet AGENCY: Food and Drug Administration, Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 11601 Landsdown St., North Bethesda, MD 20852, 301–796– 7726, PRAStaff@fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: HHS. ACTION: 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 August 17, 2017. 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: 202–395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0539. Also include the FDA docket number found in brackets in the heading of this document. Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of SUMMARY: VerDate Sep<11>2014 17:47 Jul 17, 2017 Jkt 241001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: Animal Drug User Fee Cover Sheet OMB Control Number 0910–0539— Extension Under section 740 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 379j–12), FDA has the authority to assess and collect application fees from each person who submits certain new animal drug applications or certain supplemental animal drug applications. The Animal Drug User Fee cover sheet (Form FDA 3546) is designed to collect the minimum necessary information to determine whether a fee is required for the review of an application or supplement or whether an application fee waiver was granted, to determine the amount of the fee required, and to assure that each animal drug user fee payment is appropriately linked to the E:\FR\FM\18JYN1.SGM 18JYN1

Agencies

[Federal Register Volume 82, Number 136 (Tuesday, July 18, 2017)]
[Notices]
[Pages 32825-32826]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15005]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-0040]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Draft Guidance for 
Industry; How To Prepare a Pre-Request for Designation

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 August 
17, 2017.

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: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910--NEW and 
title ``Draft Guidance for Industry; How to Prepare a Pre-Request for 
Designation (Pre-RFD).'' Also include the FDA docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
PRAStaff@fda.hhs.gov.

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.

Draft Guidance for Industry; How To Prepare a Pre-Request for 
Designation (Pre-RFD)

OMB Control Number 0910--NEW

    Since its establishment on December 24, 2002, the FDA Office of 
Combination Products (OCP) has served as a resource for sponsors at 
various stages of development of their product. Sponsors often seek OCP 
feedback on whether their medical product will be regulated as a drug, 
a device, a biologic,

[[Page 32826]]

or a combination product, and which FDA medical product Agency Center 
(Center for Drug Evaluation and Research, Center for Biologics 
Evaluation and Research, or Center for Devices and Radiological Health) 
will regulate it, if it is a non-combination product, or will have the 
primary jurisdiction for the premarket review and regulation of the 
product, if it is a combination product.
    There are two ways that a sponsor can receive such feedback from 
OCP. One option is to submit an RFD to receive a formal, binding 
determination for the sponsor's product with respect to classification 
and/or center assignment that may be changed under conditions specified 
in section 563 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb-2) and 21 CFR 3.9 in the regulations. The RFD process is 
codified in 21 CFR part 3, and OCP has issued a guidance about this 
process (see ``How to Write a Request for Designation'' at https://www.fda.gov/RegulatoryInformation/Guidances/ucm126053.htm). A second 
more flexible option is for a sponsor to submit an inquiry to OCP to 
receive a preliminary jurisdictional assessment, which is not binding.
    Many sponsors seek to utilize the flexibility of more approachable 
ways to interact with OCP and the medical product Agency Centers to 
obtain feedback from the Agency before submitting a marketing 
application to the Agency. Over time, these informal methods of 
obtaining feedback have become increasingly customary with sponsors, 
and for some, even preferable to the formal RFD process. Accordingly, 
FDA is enhancing the transparency and consistency of this process, 
which will now be called the ``Pre-Request for Designation (Pre-RFD) 
Program.''
    This draft guidance describes this structured process with clear 
recommendations for sponsors wishing to submit Pre-RFDs. It also 
provides the process for review of Pre-RFDs by FDA staff, the general 
timeframes for sponsors to receive feedback from OCP, and the process 
for scheduling teleconferences and meetings in relation to a Pre-RFD.
    This draft guidance describes how to prepare a Pre-RFD. The 
guidance provides recommendations regarding the information that should 
be submitted in a Pre-RFD request and procedures that should be 
followed for meetings or conference calls between OCP, the Centers, and 
industry representatives or sponsors.
    The proposed collections of information are necessary to allow the 
Agency to receive Pre-RFD requests in order to implement this voluntary 
submission program.
    In the Federal Register of January 13, 2017 (82 FR 4351), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Although two comments were received, they 
were not responsive to the four collection of information topics 
solicited and therefore will not be discussed.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                               Number of
                                                  Number of    responses      Total       Average
                    Activity                     respondents      per         annual     burden per  Total hours
                                                               respondent   responses     response
----------------------------------------------------------------------------------------------------------------
Pre-RFD Submissions............................          136            1          136           12        1,632
Pre-RFD Meetings...............................          136            1          136            1          136
                                                ----------------------------------------------------------------
    Total......................................  ...........  ...........  ...........  ...........        1,768
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: July 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-15005 Filed 7-17-17; 8:45 am]
BILLING CODE 4164-01-P

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