[Federal Register: December 12, 2006 (Volume 71, Number 238)]
[Notices]
[Page 74506-74507]
[DOCID:fr12de06-72]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-20-001]

Texas Eastern Transmission, LP; Notice of Tariff Filing

December 6, 2006.
    Take notice that on December 1, 2006, Texas Eastern Transmission,
LP (Texas Eastern) tendered for filing as part of its FERC Gas Tariff,
Seventh Revised

Volume No. 1, Substitute Fourth Revised Sheet No. 127 to become
effective December 1, 2006.
    Texas Eastern states that copies of its filing have been mailed or,
if requested, emailed to all affected customers of Texas Eastern and
interested state commissions, and to all parties on the Commission's
official service list in this proceeding.
    Any person desiring to protest this filing must file in accordance
with Rule 211 of the Commission's Rules of Practice and Procedure (18
CFR 385.211). Protests to this filing will be considered by the
Commission in determining the appropriate action to be taken, but will
not serve to make protestants parties to the proceeding. Such protests
must be filed in accordance with the provisions of Section 154.210 of
the Commission's regulations (18 CFR 154.210). Anyone filing a protest
must serve a copy of that document on all the parties to the
proceeding.
    The Commission encourages electronic submission of protests in lieu
of paper using the ``eFiling'' link at http://www.ferc.gov. Persons

unable to file electronically should submit an original and 14 copies
of the protest to the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E6-21097 Filed 12-11-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: February 21, 2006 (Volume 71, Number 34)]
[Notices]
[Page 8851-8852]
[DOCID:fr21fe06-48]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2005-0031; FRL-8034-6]

Agency Information Collection Activities; Submission for OMB
Review and Approval; Comment Request; NESHAP for Municipal Solid Waste
Landfills (Renewal), ICR Number 1938.03, OMB Number 2060-0505

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act, this document
announces that an Information Collection Request (ICR) has been
forwarded to the Office of Management and Budget (OMB) for review and
approval. This is a request to renew an existing approved collection.
This ICR is scheduled to expire on April 30, 2006. Under OMB
regulations, the Agency may continue to conduct or sponsor the
collection of information while this submission is pending at OMB. This
ICR describes the nature of the information collection and its
estimated burden and cost.

DATES: Additional comments may be submitted on or before March 23,
2006.

ADDRESSES: Submit your comments, referencing docket ID number EPA-HQ-
OECA-2005-0031, to (1) EPA online using http://www.regulations.gov (our preferred method), by e-mail to<EMAIL_ADDRESS>or by mail to: EPA

Docket Center (EPA/DC), Environmental Protection Agency, Enforcement
and Compliance Docket and Information Center, Mail Code 2201T, 1200
Pennsylvania Avenue, NW., Washington, DC 20460, and (2) OMB at: Office
of Information and Regulatory Affairs, Office of Management and Budget
(OMB), Attention: Desk Officer for EPA, 725 17th Street, NW.,
Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Learia Williams, Compliance Assessment
and Media Programs Division, Office of Compliance, (Mail Code 2223A),
Environmental Protection Agency, 1200 Pennsylvania Avenue, NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number:
(202) 564-0050; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On May 6, 2005 (70 FR 24020), EPA sought comments on this ICR
pursuant to 5 CFR 1320.8(d). EPA received no comments.
    EPA has established a public docket for this ICR under Docket ID
Number EPA-HQ-OECA 2005-0031, which is available for online viewing at
http://www.regulations.gov, or in person viewing at the Enforcement and

Compliance Docket and Information Center in the EPA Docket Center (EPA/
DC), EPA West, Room B102, 1301 Constitution Avenue, NW., Washington,
DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday,

excluding legal holidays. The telephone number for the Reading Room is
(202) 566-1744, and the telephone number for the Enforcement and
Compliance Docket and Information Center Docket is:<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at http://www.regulations.gov
 to submit or view public comments, access the index

listing of the contents of the public docket, and to access those
documents in the public docket that are available electronically. When
in the system, select ``search,'' then key in the docket ID number
identified above.
    Any comments related to this ICR should be submitted to EPA and OMB
within 30 days of this notice. EPA's policy is that public comments,
whether submitted electronically or in paper, will be made available
for public viewing at http://www.regulations.gov as EPA receives them

and without change, unless the comment contains copyrighted material,
Confidential Business Information (CBI), or other information whose
public disclosure is restricted by statute. When EPA identifies a
comment containing copyrighted material, EPA will provide a reference
to that material in the version of the comment that is placed in http://www.regulations.gov.
 The entire printed comment, including the

copyrighted material, will be available in the public docket. Although
identified as an item in the official docket, information claimed as
CBI, or whose disclosure is otherwise restricted by statute, is not
included in the official public docket, and will not be available for
public viewing at http://www.regulations.gov For further information about the electronic docket, go to http://www.regulations.gov.

    Title: NESHAP for Municipal Solid Waste Landfills (Renewal).
    Abstract: The National Emission Standards for Hazardous Air
Pollutants (NESHAP) for municipal solid waste landfills were proposed
on November 7, 2000, and promulgated on January 16, 2003. These
standards apply to each existing and new municipal solid waste (MSW)
landfills. This subpart applies to a MSW landfill that has accepted
waste since November 8, 1987 or has additional capacity for waste
deposition, a major source, collocated with a major source, and an area
source landfill with a design capacity equal to or greater than 2.5
million megagrams (Mg) and 2.5 million cubic meters (m3),
and has estimated uncontrolled emissions equal to or greater than 50
megagrams per year (Mg/yr) of nonmethane organic compounds (NMOC), or a
MSW landfill that has accepted waste since November 8, 1987 or has
additional capacity for waste deposition, that includes a bioreactor,
is a major source, collocated with a major source, and an area source
with a design capacity equal to or greater than 2.5 million Mg and 2.5
million m3 that is not permanently closed as of January 16,
2003.
    Owners or operators of the affected facilities would be required to
submit semiannual compliance reports for control device operating
parameters prepare a startup, shutdown, and malfunction (SSM) plan and
prepare semiannual SSM reports.
    Any owner or operator subject to the provisions of this subpart
must maintain a file of these measurements, and retain the file for at
least two years following the collection of such measurements,
maintenance reports, and records. All reports are sent to the delegated
state or local authority. In the event that there is no such delegated
authority, the reports are sent directly to the regional EPA office.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB Control Number. The OMB Control Numbers for EPA's
regulations are listed in 40 CFR part 9 and 48 CFR chapter 15, and are
identified on the form and/or instrument, if applicable.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average five
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements; train personnel to be able to respond to
a collection of information; search data sources; complete and review
the collection of information; and transmit or otherwise disclose the
information.
    Respondents/Affected Entities: Owner or operator of each municipal
solid waste landfill.
    Estimated Number of Respondents: 1,121.
    Frequency of Response: On occasion, semi-annually, and annually.
    Estimated Total Annual Hour Burden: 18,234 hours.
    Estimated Total Annual Costs: $1,489,837, which includes $0
annualized capital/startup costs, $17,000 annual O&M costs, and
$1,472,837 annual labor costs.
    Changes in the Estimates: There was a decrease of 21,126 hours in
the total estimated burden currently identified in the OMB Inventory of
Approved ICR Burdens. The adjustment decrease in burden from the most
recently approved ICR is due to a decrease in the number of sources.
After we conducted a thorough analysis with the municipal solid waste
landfills industry and obtained their spreadsheet that depicts MSW
landfills whose capacity met or exceeded 2.5 million Mg, we were able
to determine that there are 1,119 active landfills with a projection of
one additional landfill per year over the next three years, for a total
average of 1,121, as compared to 1,330 in the previous ICR. In
addition, the startup, shutdown and malfunction plan has been completed
for existing facilities. This only applies to a facility when it first
becomes subject to the standard. The plans were completed, by in large,
during the last ICR cycle.
    The capital/startup costs are not included because this NESHAP does
not require MSW landfills to purchase or operate additional control
equipment or monitoring devices.

    Dated: February 7, 2006.
Oscar Morales,
Director, Collection Strategies Division.
 [FR Doc. E6-2407 Filed 2-17-06; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 70 (Thursday, April 13, 2017)]
[Notices]
[Page 17850]
[FR Doc No: 2017-07431]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4308-DR; Docket ID FEMA-2017-0001]

California; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of California (FEMA-4308-DR), dated April 1,
2017, and related determinations.

DATES: Effective Date: April 1, 2017.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated April 1, 2017, the President issued a major disaster declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''), as follows:

    I have determined that the damage in certain areas of the State
of California resulting from severe winter storms, flooding, and
mudslides during the period of February 1-23, 2017, is of sufficient
severity and magnitude to warrant a major disaster declaration under
the Robert T. Stafford Disaster Relief and Emergency Assistance Act,
42 U.S.C. 5121 et seq. (the ``Stafford Act''). Therefore, I declare
that such a major disaster exists in the State of California.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance in the
designated areas and Hazard Mitigation throughout the State.
Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Hazard Mitigation will be limited to 75 percent of the total
eligible costs. Federal funds provided under the Stafford Act for
Public Assistance also will be limited to 75 percent of the total
eligible costs, with the exception of projects that meet the
eligibility criteria for a higher Federal cost-sharing percentage
under the Public Assistance Alternative Procedures Pilot Program for
Debris Removal implemented pursuant to section 428 of the Stafford
Act.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Timothy J. Scranton, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the State of California have been designated
as adversely affected by this major disaster:

    Alameda, Alpine, Amador, Butte, Calaveras, Colusa, Contra Costa,
Del Norte, El Dorado, Glenn, Humboldt, Kings, Lake, Lassen, Marin,
Mariposa, Merced, Modoc, Monterey, Napa, Nevada, Plumas, Sacramento,
San Benito, San Joaquin, San Luis Obispo, San Mateo, Santa Barbara,
Santa Clara, Santa Cruz, Shasta, Sierra, Siskiyou, Solano, Sonoma,
Stanislaus, Sutter, Tehama, Trinity, Tuolumne, Yolo, and Yuba
Counties for Public Assistance.
    All areas within the State of California are eligible for
assistance under the Hazard Mitigation Grant Program.
    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Robert J. Fenton,
Acting Administrator, Federal Emergency Management Agency.
[FR Doc. 2017-07431 Filed 4-12-17; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register Volume 87, Number 98 (Friday, May 20, 2022)]
[Proposed Rules]
[Pages 30843-30845]
[FR Doc No: 2022-10942]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 190

[Docket No. FDA-2022-D-0281]

Policy Regarding Certain New Dietary Ingredients and Dietary
Supplements Subject to the Requirement for Pre-Market Notification;
Draft Guidance for Industry; Availability; Agency Information
Collection Activities; Proposed Collection; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a draft guidance for industry entitled ``Policy
Regarding Certain New Dietary Ingredients and Dietary Supplements
Subject to the Requirement for Pre-market Notification.'' The draft
guidance, when finalized, will advise the dietary supplement industry
of our intent to exercise enforcement discretion, for a limited time
and in limited circumstances, regarding the requirement to submit a new
dietary ingredient (NDI) notification prior to marketing. The purpose
of the policy is to encourage manufacturers and distributors of certain
NDI-containing dietary supplements to correct any past failures to
submit a required NDI notification.

DATES: Submit either electronic or written comments on the draft
guidance by July 19, 2022 to ensure that we consider your comment on
the draft guidance before we begin work on the final version of the
guidance. Submit written comments (including recommendations) on the
collection of information under the Paperwork Reduction Act of 1995 by
July 19, 2022.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

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-2022-D-0281 for ``Policy Regarding Certain New Dietary Ingredients
and Dietary Supplements Subject to the Requirement for Pre-market
Notification.'' Received comments 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,<PHONE_NUMBER>.
     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.'' We will review
this copy, including the claimed confidential information, in our
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 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,<PHONE_NUMBER>.
    Submit comments on the information collection under the Paperwork
Reduction Act of 1995 to the Office of Management and Budget (OMB) at
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 title of this
proposed collection is ``Policy Regarding Certain New Dietary
Ingredients and Dietary Supplements Subject to the Requirement for Pre-
market Notification; Draft Guidance for Industry.''
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Office of Dietary Supplement Programs, Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740. Send two self-addressed adhesive labels to
assist that office in processing your request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: With regard to the draft guidance:
Laura Rich, Office of Dietary Supplement Programs (HFS-810), Center for
Food Safety and Applied Nutrition, Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740,<PHONE_NUMBER>; or Alexandra
Jurewitz, Office of Regulations and Policy (HFS-024), Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740,<PHONE_NUMBER>.
    With regard to the proposed collection of information: 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:

I. Background

    We are announcing the availability of a draft guidance for industry
entitled ``Policy Regarding Certain New Dietary Ingredients and Dietary
Supplements Subject to the Requirement for Pre-market Notification.''
We are issuing the draft guidance consistent with our good guidance
practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on this topic. It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternate approach if it satisfies the
requirements of the applicable statutes and regulations.
    The draft guidance, when finalized, will advise manufacturers and
distributors of certain NDI-containing dietary supplements (namely,
those that are subject to the premarket notification requirement and
are being marketed without such a notification) of FDA's intent to
exercise enforcement discretion for such firms to submit a late NDI
notification for a limited time and in limited circumstances.

II. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/FoodGuidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov. Use the FDA website listed in the previous
sentence to find the most current version of the guidance.

III. Paperwork Reduction Act

    Under the Paperwork Reduction Act of 1995 (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 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.

Policy Regarding Certain New Dietary Ingredients and Dietary
Supplements Subject to the Requirement for Pre-Market Notification

OMB Control Number 0910--NEW

    This draft guidance, when finalized, is intended to advise the
dietary supplement industry of our intent to exercise enforcement
discretion, for a limited time and in limited circumstances, regarding
the requirement to submit an NDI notification prior to marketing. The
purpose of the policy is to encourage manufacturers and distributors of
certain NDI-containing dietary supplements to correct any past failures
to submit an NDI notification as required by Sec.  190.6 (21 CFR
190.6). The proposed information collection requests that manufacturers
and distributors who submit a late NDI notification under the
enforcement discretion policy in the draft guidance supplement the
notification with the following additional information: (1) A copy of
the current label for the dietary supplement containing the NDI and (2)
documentation to demonstrate the date that the dietary supplement was
first introduced or delivered for introduction into interstate
commerce.
    We are developing a new submission type in the CFSAN Online
Submission Module that will be used for late notifications submitted
under the temporary enforcement discretion policy if the draft guidance
is finalized. A draft screenshot of the questions specific to late
notifications is available for comment at https://www.fda.gov/food/new-dietary-ingredients-ndi-notification-process/how-submit-notifications-new-dietary-ingredient.
    Description of Respondents: The respondents to this collection of
information are manufacturers and distributors in the dietary
supplement industry; specifically, firms that failed to comply with the
NDI notification requirements in Sec.  190.6 and that wish to take
advantage of FDA's temporary enforcement discretion policy to submit a
late NDI notification.
    FDA estimates the burden of this collection of information as
follows:

                                                    Table 1--Estimated One-Time Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
                   Activity                       Number of     responses per       Total        Average burden per response (in hours)     Total hours
                                                 respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submit product label and documentation of               3,500               1           3,500  0.30 (18 minutes)........................           1,050
 date of introduction into interstate
 commerce to FDA.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The estimates in table 1 are based on our experience with our
current NDI program. We estimate that 3,500 respondents will submit
their product labels and documentation of dates of introduction into
interstate commerce and that each respondent will submit 1 product
label and corresponding documentation of date of introduction into
interstate commerce. We further estimate that preparing and submitting
each response will take approximately 0.30 hour (18 minutes), resulting
in a total reporting burden of 1,050 hours (3,500 responses x 0.30
hour). This will be a temporary collection of information, as we expect
to conduct this program for 6 months.
    This draft guidance also refers to previously approved FDA
collections of information. The collections of information in Sec.
190.6 have been approved under OMB control number 0910-0330.

    Dated: May 17, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-10942 Filed 5-19-22; 8:45 am]
BILLING CODE 4164-01-P