Agency Information Collection Activities; Proposed Collection; Comment Request; Temporary Marketing Permit Applications, 21247-21249 [2020-08009]

Download as PDF Federal Register / Vol. 85, No. 74 / Thursday, April 16, 2020 / Notices Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301– 796–7726, PRAStaff@fda.hhs.gov. In a notice published in the Federal Register of March 6, 2020 (85 FR 13171), ‘‘Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Safety Communication Readership Survey,’’ FDA requested comment on the information collection associated with Safety Communication Readership Surveys. 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. In the March 6, 2020, Federal Register document, FDA proposed to extend the information collection related to the Safety Communication Readership Survey (OMB control number 0910– 0341). However, we are withdrawing the notice because, upon further review of the information collection request (ICR), we have determined that it is more appropriate to include the estimated burden expressed in the Safety Communication Readership Survey ICR in the ‘‘generic’’ ICR for ‘‘Testing Communications on Medical Devices and Radiation-Emitting Products’’ (OMB control number 0910–0678). Because we intend to submit information collections for safety communication readership surveys under the generic information collection approval, OMB control number 0910– 0678, we will discontinue the ICR for OMB control number 0910–0341 and we are withdrawing the March 6, 2020, document requesting comment on the information collection. SUPPLEMENTARY INFORMATION: Dated: April 8, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–08004 Filed 4–15–20; 8:45 am] jbell on DSKJLSW7X2PROD with NOTICES BILLING CODE 4164–01–P VerDate Sep<11>2014 18:20 Apr 15, 2020 Jkt 250001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0424] Agency Information Collection Activities; Proposed Collection; Comment Request; Temporary Marketing Permit Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (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 reporting requirements contained in existing FDA regulations governing temporary marketing permit applications. DATES: Submit either electronic or written comments on the collection of information by June 15, 2020. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before June 15, 2020. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of June 15, 2020. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 21247 confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2011–N–0424 for ‘‘Agency Information Collection Activities; Proposed Collection; Comment Request; Temporary Marketing Permit Applications.’’ Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not E:\FR\FM\16APN1.SGM 16APN1 21248 Federal Register / Vol. 85, No. 74 / Thursday, April 16, 2020 / Notices in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https:// www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–5733, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501–3521), 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. Temporary Marketing Permit Applications—21 CFR 130.17(c) and (i) OMB Control Number 0910–0133— Extension Section 401 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341) (FD&C Act) directs FDA to issue regulations establishing definitions and standards of identity for food. Under section 403(g) of the FD&C Act (21 U.S.C. 343(g)), a food that is subject to a definition and standard of identity prescribed by regulation is misbranded if it does not conform to such definition and standard of identity. Section 130.17 (21 CFR 130.17) provides for the issuance by FDA of temporary marketing permits that enable the food industry to test consumer acceptance and measure the technological and commercial feasibility in interstate commerce of experimental packs of food that deviate from applicable definitions and standards of identity. Section 130.17(c) enables the Agency to monitor the manufacture, labeling, and distribution of experimental packs of food that deviate from applicable definitions and standards of identity. The information so obtained can be used in support of a petition to establish or amend the applicable definition or standard of identity to provide for the variations. Section 130.17(i) specifies the information that a firm must submit to FDA to obtain an extension of a temporary marketing permit. Description of Respondents: Respondents to this collection of information include private sector businesses including institutional and/ or industrial customers and food industry members such as manufacturers, packers, or distributors desiring to apply for a temporary marketing permit or permit extension. We estimate the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents 21 CFR section; activity Total annual responses Average burden per response (in hours) Total hours 130.17(c); Request for temporary marketing permit ........... 130.17(i); Request to extend marketing permit ................... 13 1 2 2 26 2 25 2 650 4 Total .............................................................................. ........................ ........................ ........................ ........................ 654 1 There jbell on DSKJLSW7X2PROD with NOTICES Number of responses per respondent are no capital costs or operating and maintenance costs associated with this collection of information. VerDate Sep<11>2014 18:20 Apr 15, 2020 Jkt 250001 PO 00000 Frm 00087 Fmt 4703 Sfmt 9990 E:\FR\FM\16APN1.SGM 16APN1 Federal Register / Vol. 85, No. 74 / Thursday, April 16, 2020 / Notices Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate. Dated: April 3, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–08009 Filed 4–15–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–N–0366] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Advisory Committee Nomination Applications 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 (PRA). SUMMARY: Submit written comments (including recommendations) on the collection of information by May 18, 2020. DATES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https:// www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting ‘‘Currently under Review—Open for Public Comments’’ or by using the search function. The OMB control number for this information collection is 0910–0833. Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: jbell on DSKJLSW7X2PROD with NOTICES 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. 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: VerDate Sep<11>2014 18:20 Apr 15, 2020 Jkt 250001 FDA Advisory Committee Membership Nominations OMB Control Number 0910–0833 FDA chooses to select advisory committee members through a nomination process. (Appendix A to Subpart C of 41 CFR 102–3, the Federal Advisory Committee Management regulations note that the Federal Advisory Committee Act (FACA, 5 U.S.C. App. 2) does not specify the manner in which advisory committee members and staff must be appointed.) A person can self-nominate or be nominated by another individual. In order to identify and select qualified individuals to serve on its advisory committees, FDA has established an online portal, the FDA Advisory Committee Membership Application, to accept nominations of potential advisory committee members. The FDA Advisory Committee Membership Application accepts nominations for Academician/ Practitioner, Consumer Representative, and Industry Representative membership types. Nominees who are nominated as scientific members should be technically qualified experts in the field (e.g., clinical medicine, engineering, biological and physical sciences, biostatistics, food sciences) and have experience interpreting complex data. Candidates must be able to analyze detailed scientific data and understand its public health significance. The nomination process has recently been made electronic and is available at https:// accessdata.test.fda.gov/scripts/ FACTRSPortal/FACTRS/index.cfm. To submit a nomination, nominators or prospective nominees should upload the following documents in PDF format (see 21 CFR 14.82(c)): (1) Curriculum vitae (CV); (2) a written confirmation that the nominee(s) is (are) aware of the nomination (unless self-nominated); and (3) letters of recommendation are also suggested. For Consumer Representative nominations, a cover letter that lists consumer or community organizations for which the candidate can demonstrate active participation is also recommended. These documents are collected in order to determine if the nominee has the expertise in the subject matter with which the committee is concerned and has diverse professional education, training, and experience so that the committee will reflect a balanced composition of sufficient scientific expertise to handle the problems that come before it (21 CFR 14.80(b)(1)(i)). In the case of Industry and Consumer Representatives, information is PO 00000 Frm 00088 Fmt 4703 Sfmt 4703 21249 collected to assess the candidate’s ability to represent all interested persons within the class which the member is selected to represent (21 CFR 14.86). Each nominee should be sure to review the Agency website for information on: • Vacancies, qualifications, and experience for more details concerning vacancies on each committee and the qualifications and experience common for nominees. Vacancies are updated periodically; therefore, one or more vacancies listed may be in the nomination process or a final appointment may have been made. • Potential conflicts of interest such as financial holdings, employment, and research grants and/or contracts in order to permit evaluation of possible sources of conflict of interest. Also, FDA asks that prospective nominees inform us of how they heard about the FDA Advisory Committees (e.g., attendance at a professional meeting, an article in a publication, our website, while speaking with a friend or colleague). To further the Agency’s goals of promoting transparency regarding the advisory committee process, FDA will also require that nominees to serve on advisory committees submit a consent form authorizing FDA to post, without removing or redacting any information, to FDA’s public website (https:// www.fda.gov/AdvisoryCommittees) the CV submitted as part of their nomination materials if the nominee is selected to serve on an advisory committee. The consent form requires that the nominee affirm that the CV does not include any confidential information, including information pertaining to third parties, that the nominee is not permitted to disclose. A nominee will be required to submit a signed consent form as a part of the nomination package for the nomination to be considered complete. All nominations for new advisory committee members will be required to be submitted through FDA’s website at https://accessdata.test.fda.gov/scripts/ FACTRSPortal/FACTRS/index.cfm, or any successor system, and the submission will be required to be accompanied by the consent form, on or after the date of OMB approval for this information collection. In the Federal Register of January 7, 2020 (85 FR 718), we published a 60day notice requesting public comment on the proposed collection of information. Two comments were received but were not responsive to the information collection topics solicited under the PRA. E:\FR\FM\16APN1.SGM 16APN1

Agencies

[Federal Register Volume 85, Number 74 (Thursday, April 16, 2020)]
[Notices]
[Pages 21247-21249]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08009]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0424]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Temporary Marketing Permit Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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 reporting requirements contained in 
existing FDA regulations governing temporary marketing permit 
applications.

DATES: Submit either electronic or written comments on the collection 
of information by June 15, 2020.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before June 15, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of June 15, 2020. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2011-N-0424 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Temporary Marketing Permit 
Applications.'' Received comments, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not

[[Page 21248]]

in the body of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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.

Temporary Marketing Permit Applications--21 CFR 130.17(c) and (i)

OMB Control Number 0910-0133--Extension

    Section 401 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
341) (FD&C Act) directs FDA to issue regulations establishing 
definitions and standards of identity for food. Under section 403(g) of 
the FD&C Act (21 U.S.C. 343(g)), a food that is subject to a definition 
and standard of identity prescribed by regulation is misbranded if it 
does not conform to such definition and standard of identity. Section 
130.17 (21 CFR 130.17) provides for the issuance by FDA of temporary 
marketing permits that enable the food industry to test consumer 
acceptance and measure the technological and commercial feasibility in 
interstate commerce of experimental packs of food that deviate from 
applicable definitions and standards of identity. Section 130.17(c) 
enables the Agency to monitor the manufacture, labeling, and 
distribution of experimental packs of food that deviate from applicable 
definitions and standards of identity. The information so obtained can 
be used in support of a petition to establish or amend the applicable 
definition or standard of identity to provide for the variations. 
Section 130.17(i) specifies the information that a firm must submit to 
FDA to obtain an extension of a temporary marketing permit.
    Description of Respondents: Respondents to this collection of 
information include private sector businesses including institutional 
and/or industrial customers and food industry members such as 
manufacturers, packers, or distributors desiring to apply for a 
temporary marketing permit or permit extension.
    We estimate the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
    21 CFR section; activity         Number of     responses per   Total annual    per response     Total hours
                                    respondents     respondent       responses      (in hours)
----------------------------------------------------------------------------------------------------------------
130.17(c); Request for temporary              13               2              26              25             650
 marketing permit...............
130.17(i); Request to extend                   1               2               2               2               4
 marketing permit...............
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             654
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 21249]]

    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate.

    Dated: April 3, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-08009 Filed 4-15-20; 8:45 am]
 BILLING CODE 4164-01-P
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