82 FR 32825 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry; How To Prepare a Pre-Request for Designation
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 136 (July 18, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 136 (July 18, 2017)
| Page Range | 32825-32826 | |
| FR Document | 2017-15005 |
[Federal Register Volume 82, Number 136 (Tuesday, July 18, 2017)] [Notices] [Pages 32825-32826] From the Federal Register Online [www.thefederalregister.org] [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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry; How To Prepare a Pre-Request for Designation AGENCY: Food and Drug Administration, HHS.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 [email protected]. All comments should be identified with the OMB control number 0910--NEW and title ``Draft Guidance for Industry; How to Prepare a Pre-Request for Designation (Pre-RFD).''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, [email protected]. 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 Draft Guidance for Industry; How To Prepare a Pre-Request for Designation (Pre-RFD) OMB Control Number 0910--NEW Since its establishment on December 24, 2002, the FDA Office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
![Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices 32825
purportedly ‘‘VOC-free’’ paints. ‘‘VOC’’ representation prohibited by Parts I or DEPARTMENT OF HEALTH AND
is the abbreviation for volatile organic II. HUMAN SERVICES
compounds. VOC-free includes claims To correct existing unsubstantiated
such as ‘‘zero VOCs,’’ ‘‘0 VOCs,’’ and Food and Drug Administration
zero emission and VOC claims, Part III
‘‘No VOCs.’’ According to the FTC requires the respondent to send letters [Docket No. FDA–2017–D–0040]
complaint, respondent made
to its dealers and distributors,
unsubstantiated representations that its Agency Information Collection
instructing them to put stickers on paint
paints: (1) Are VOC-free; (2) are VOC- Activities; Submission for Office of
free during or immediately after cans to obscure allegedly
unsubstantiated emission and VOC Management and Budget Review;
painting; (3) will not emit any chemical Comment Request; Draft Guidance for
or substance, including VOCs, that claims.
Industry; How To Prepare a Pre-
causes material harm to consumers, Parts V through IX are reporting and Request for Designation
including sensitive populations such as compliance provisions. Part V mandates
children; and (4) will not emit any that respondent acknowledge receipt of AGENCY: Food and Drug Administration,
chemical or substance, including VOCs, the order, distribute the order to certain HHS.
during or immediately after painting, employees and agents, and secure ACTION: Notice.
that causes material harm to consumers, acknowledgments from recipients of the
including sensitive populations such as order. Part VI requires that respondent SUMMARY: The Food and Drug
children. The FTC further alleges that submit compliance reports to the FTC Administration (FDA) is announcing
respondent provided independent that a proposed collection of
within sixty (60) days of the order’s
retailers with promotional materials information has been submitted to the
issuance and submit additional reports
containing the same claims it made to Office of Management and Budget
when certain events occur. Part VII (OMB) for review and clearance under
consumers. Thus, the complaint alleges requires that respondent must create
that respondent engaged in deceptive the Paperwork Reduction Act of 1995.
and retain certain records for five (5)
practices in violation of Section 5(a) of DATES: Fax written comments on the
years. Part VIII provides for the FTC’s
the FTC Act. collection of information by August 17,
continued compliance monitoring of
The proposed consent order contains 2017.
respondent’s activity during the order’s
three provisions designed to prevent effective dates. Part IX is a provision ADDRESSES: To ensure that comments on
respondent from engaging in similar ‘‘sunsetting’’ the order after twenty (20) the information collection are received,
acts and practices in the future. Part I OMB recommends that written
years, with certain exceptions.
prohibits emission-free and VOC-free comments be faxed to the Office of
claims unless both content and If the Commission finalizes the Information and Regulatory Affairs,
emissions are actually zero or at trace agreement’s proposed order, it plans to OMB, Attn: FDA Desk Officer, FAX:
levels. The orders define ‘‘emission’’ to propose harmonizing with this order the 202–395–7285, or emailed to oira_
include all emissions (not just VOCs consent orders issued in the PPG submission@omb.eop.gov. All
that cause smog). This definition reflects Architectural Finishes, Inc. (Docket No. comments should be identified with the
the Commission’s Enforcement Policy C–4385) and The Sherwin-Williams OMB control number 0910—NEW and
Statement and consumer expectations: Company (Docket No. C–4386) matters. title ‘‘Draft Guidance for Industry; How
consumers are likely concerned about Specifically, the Commission plans to to Prepare a Pre-Request for Designation
the potential health effects from issue orders to show cause why those (Pre-RFD).’’ Also include the FDA
exposure to chemical emissions found matters should not be modified docket number found in brackets in the
in indoor air, not just VOCs that affect pursuant to Section 3.72(b) of the heading of this document.
outdoor air quality. The order defines Commission Rules of Practice, 16 CFR FOR FURTHER INFORMATION CONTACT:
‘‘trace level of emission’’ to mean (1) no 3.72(b). Amber Sanford, Office of Operations,
intentionally added VOC, (2) emission Food and Drug Administration, Three
of the covered product does not cause The purpose of the analysis is to aid
public comment on the proposed order. White Flint North 10A–12M, 11601
material harm that consumers typically Landsdown St., North Bethesda, MD
associate with emission, including harm It is not intended to constitute an
20852, 301–796–8867, PRAStaff@
to the environment or human health, official interpretation of the proposed
fda.hhs.gov.
and (3) emission of the covered product order or to modify its terms in any way.
does not result in more than harmless SUPPLEMENTARY INFORMATION: In
By direction of the Commission.
concentrations of and compound higher compliance with 44 U.S.C. 3507, FDA
Donald S. Clark, has submitted the following proposed
than would be found under normal
Secretary. collection of information to OMB for
conditions in the typical residential
home without interior architectural [FR Doc. 2017–14973 Filed 7–17–17; 8:45 am] review and clearance.
coating. Part II prohibits misleading BILLING CODE 6750–01–P
Draft Guidance for Industry; How To
representations regarding emission, Prepare a Pre-Request for Designation
VOC levels, odor, and any general (Pre-RFD)
environmental and health benefit of
paints. The order requires competent OMB Control Number 0910—NEW
and reliable scientific evidence to Since its establishment on December
sradovich on DSK3GMQ082PROD with NOTICES
substantiate these representations. Part 24, 2002, the FDA Office of
IV prohibits respondent from providing Combination Products (OCP) has served
third parties with the means and as a resource for sponsors at various
instrumentalities to make false, stages of development of their product.
unsubstantiated, or otherwise Sponsors often seek OCP feedback on
misleading representations of material whether their medical product will be
fact regarding paints, including any regulated as a drug, a device, a biologic,
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![32826 Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices
or a combination product, and which flexible option is for a sponsor to submit teleconferences and meetings in relation
FDA medical product Agency Center an inquiry to OCP to receive a to a Pre-RFD.
(Center for Drug Evaluation and preliminary jurisdictional assessment, This draft guidance describes how to
Research, Center for Biologics which is not binding. prepare a Pre-RFD. The guidance
Evaluation and Research, or Center for Many sponsors seek to utilize the provides recommendations regarding
Devices and Radiological Health) will flexibility of more approachable ways to the information that should be
regulate it, if it is a non-combination interact with OCP and the medical submitted in a Pre-RFD request and
product, or will have the primary product Agency Centers to obtain procedures that should be followed for
jurisdiction for the premarket review feedback from the Agency before meetings or conference calls between
and regulation of the product, if it is a submitting a marketing application to OCP, the Centers, and industry
combination product. the Agency. Over time, these informal representatives or sponsors.
There are two ways that a sponsor can
methods of obtaining feedback have The proposed collections of
receive such feedback from OCP. One
become increasingly customary with information are necessary to allow the
option is to submit an RFD to receive a
sponsors, and for some, even preferable Agency to receive Pre-RFD requests in
formal, binding determination for the
sponsor’s product with respect to to the formal RFD process. Accordingly, order to implement this voluntary
classification and/or center assignment FDA is enhancing the transparency and submission program.
that may be changed under conditions consistency of this process, which will In the Federal Register of January 13,
specified in section 563 of the Federal now be called the ‘‘Pre-Request for 2017 (82 FR 4351), FDA published a 60-
Food, Drug, and Cosmetic Act (21 U.S.C. Designation (Pre-RFD) Program.’’ day notice requesting public comment
360bbb–2) and 21 CFR 3.9 in the This draft guidance describes this on the proposed collection of
regulations. The RFD process is codified structured process with clear information. Although two comments
in 21 CFR part 3, and OCP has issued recommendations for sponsors wishing were received, they were not responsive
a guidance about this process (see ‘‘How to submit Pre-RFDs. It also provides the to the four collection of information
to Write a Request for Designation’’ at process for review of Pre-RFDs by FDA topics solicited and therefore will not be
https://www.fda.gov/ staff, the general timeframes for discussed.
RegulatoryInformation/Guidances/ sponsors to receive feedback from OCP, FDA estimates the burden of this
ucm126053.htm). A second more and the process for scheduling collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of responses Total annual
Activity burden per Total hours
respondents per responses response
respondent
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. information has been submitted to the SUPPLEMENTARY INFORMATION: In
Anna K. Abram, Office of Management and Budget compliance with 44 U.S.C. 3507, FDA
Deputy Commissioner for Policy, Planning, (OMB) for review and clearance under has submitted the following proposed
Legislation, and Analysis. the Paperwork Reduction Act of 1995. collection of information to OMB for
[FR Doc. 2017–15005 Filed 7–17–17; 8:45 am] DATES: Fax written comments on the review and clearance.
BILLING CODE 4164–01–P collection of information by August 17, Animal Drug User Fee Cover Sheet
2017. OMB Control Number 0910–0539—
ADDRESSES: To ensure that comments on Extension
DEPARTMENT OF HEALTH AND the information collection are received,
HUMAN SERVICES Under section 740 of the Federal
OMB recommends that written Food, Drug, and Cosmetic Act (the
Food and Drug Administration comments be faxed to the Office of FD&C Act) (21 U.S.C. 379j–12), FDA has
Information and Regulatory Affairs, the authority to assess and collect
[Docket No. FDA–2010–N–0600] OMB, Attn: FDA Desk Officer, FAX: application fees from each person who
202–395–7285, or emailed to oira_ submits certain new animal drug
Agency Information Collection submission@omb.eop.gov. All applications or certain supplemental
Activities; Submission for Office of comments should be identified with the animal drug applications. The Animal
Management and Budget Review; OMB control number 0910–0539. Also Drug User Fee cover sheet (Form FDA
Comment Request; Animal Drug User include the FDA docket number found 3546) is designed to collect the
Fee Cover Sheet in brackets in the heading of this minimum necessary information to
sradovich on DSK3GMQ082PROD with NOTICES
document. determine whether a fee is required for
AGENCY: Food and Drug Administration,
HHS. FOR FURTHER INFORMATION CONTACT: Ila the review of an application or
ACTION: Notice. S. Mizrachi, Office of Operations, Food supplement or whether an application
and Drug Administration, Three White fee waiver was granted, to determine the
SUMMARY: The Food and Drug Flint North, 11601 Landsdown St., amount of the fee required, and to
Administration (FDA) is announcing North Bethesda, MD 20852, 301–796– assure that each animal drug user fee
that a proposed collection of 7726, PRAStaff@fda.hhs.gov. payment is appropriately linked to the
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Document Created: 2018-10-24 11:24:36
Document Modified: 2018-10-24 11:24:36
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by August 17, 2017. | |
| 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, [email protected] | |
| FR Citation | 82 FR 32825 |
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