[Federal Register Volume 83, Number 5 (Monday, January 8, 2018)]
[Notices]
[Pages 819-821]
[FR Doc No: 2018-00095]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0231]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Adverse Experience Reporting for
Licensed Biological Products; and General Records

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) 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
February 7, 2018.

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:<PHONE_NUMBER>, or emailed to
[email protected]. All comments should be identified with the
OMB control number 0910-0308. Also include the FDA docket number found
in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[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.

Adverse Experience Reporting For Licensed Biological Products; and
General Records--21 CFR Part 600; OMB Control Number 0910-0308--
Extension

    Under the Public Health Service Act (42 U.S.C. 262), FDA may only
approve a biologics license application for a biological product that
is safe, pure, and potent. When a biological product is approved and
enters the market, the product is introduced to a larger patient
population in settings different from clinical trials. New information
generated during the postmarketing period offers further insight into
the benefits and risks of the product, and evaluation of this
information is important to ensure its safe use. FDA issued the Adverse
Experience Reporting (AER) requirements in part 600 (21 CFR part 600)
to enable FDA to take actions necessary for the protection of the
public health in response to reports of adverse experiences related to
licensed biological products. The primary purpose of FDA's AERS is to
identify potentially serious safety problems with licensed biological
products. Although premarket testing discloses a general safety profile
of a biological product's comparatively common adverse effects, the
larger and more diverse patient populations exposed to the licensed
biological product provides the opportunity to collect information on
rare, latent, and long-term effects. In addition, production and/or
distribution problems have contaminated biological products in the
past. AER reports are obtained from a variety of sources, including
manufacturers, patients, physicians, foreign regulatory agencies, and
clinical investigators. Identification of new and unexpected safety
issues through the analysis of the data in AERS contributes directly to
increased public health protection. For example, evaluation of these
safety issues enables FDA to take focused regulatory action. Such
action may include, but is not limited to, important changes to the
product's labeling (such as adding a new warning), coordination with
manufacturers to ensure adequate corrective action is taken, and
removal of a biological product from the market when necessary.
    Section 600.80(c)(1) requires licensed manufacturers or any person
whose name appears on the label of a licensed biological product to
report each adverse experience that is both serious and unexpected,
whether foreign or domestic, as soon as possible but in no case later
than 15 calendar days of initial receipt of the information by the
licensed manufacturer. These reports are known as postmarketing 15-day
Alert reports. This section also requires licensed manufacturers to
submit any followup reports within 15 calendar days of receipt of new
information or as requested by FDA, and if additional information is
not obtainable, to maintain records of the unsuccessful steps taken to
seek additional information. In addition, this section requires that a
person who submits an adverse action report to the licensed
manufacturer rather than to FDA, maintain a record of this action.
Section 600.80(e) requires licensed manufacturers to submit a 15-day
Alert report for an adverse experience obtained from a postmarketing
clinical study only if the licensed manufacturer concludes that there
is a reasonable possibility that the product caused the adverse
experience. Section 600.80(c)(2) requires licensed manufacturers to
report each adverse experience not reported in a postmarketing 15-day
Alert report at quarterly intervals, for 3 years from the date of
issuance of the biologics license, and then at annual intervals. The
majority of these periodic reports are submitted annually, since a
large percentage of currently licensed biological products have been
licensed longer than 3 years. Section 600.80(k) requires licensed
manufacturers to maintain for a period of 10 years records of all
adverse experiences known to the licensed manufacturer, including raw
data and any correspondence relating to the adverse experiences.
Section 600.81 requires licensed manufacturers to submit, at an
interval of every 6 months, information about the quantity of the
product distributed under the biologics license, including the quantity
distributed to distributors. These distribution reports provide FDA
with important information about products distributed under biologics
licenses, including the quantity, certain lot numbers, labeled date of
expiration, the fill lot numbers for the total number of dosage units
of each strength or potency distributed (e.g., 50,000 per 10-milliliter
vials), and date of release. FDA may require the licensed manufacturer
to submit distribution reports under this section at times other than
every 6 months. Under Sec.  600.82(a), an applicant of a biological
product or blood and blood component must notify FDA of a permanent
discontinuance of manufacture or an interruption in manufacturing or
disruption in supply, as applicable. Under Sec. Sec.  600.80(h)(2) and
600.81(b)(2), a licensed manufacturer may request a temporary waiver
for the requirements under Sec.  600.80(h)(1) and (b)(1), respectively.
Requests for waivers must be submitted in accordance with Sec.  600.90.
Under Sec.  600.90, a licensed manufacturer may submit a waiver request
for any requirements that apply to the licensed manufacturer under
Sec. Sec.  600.80 and 600.81. A waiver request submitted under Sec.
600.90 must include supporting documentation.
    Manufacturers of biological products for human use must keep
records of each step in the manufacture and distribution of a product,
including any recalls. These recordkeeping requirements serve
preventative and remedial purposes by establishing accountability and
traceability in the manufacture and distribution of products. These
requirements also enable FDA to perform meaningful inspections. Section
600.12 requires, among other things, that records be made concurrently
with the performance of each step in the manufacture and distribution
of products. These records must be retained for no less than 5 years
after the records of manufacture have been completed or 6 months after
the latest expiration date for the individual product, whichever
represents a later date. In addition, under Sec.  600.12, manufacturers
must maintain records relating to the sterilization of equipment and
supplies, animal necropsy records, and records in cases of divided
manufacturing responsibility with respect to a product. Under Sec.
600.12(b)(2), manufacturers are also required to maintain complete
records pertaining to the recall from distribution of any product.
Furthermore, Sec.  610.18(b) (21 CFR 610.18(b)) requires, in part, that
the results of all periodic tests for verification of cultures and
determination of freedom from extraneous organisms be recorded and

retained. The recordkeeping requirements for Sec. Sec.  610.12(g),
610.13(a)(2), 610.18(d), 21 CFR 680.2(f), and 680.3(f) are approved
under OMB control number 0910-0139.
    Respondents to this collection of information include manufacturers
of biological products (including blood and blood components) and any
person whose name appears on the label of a licensed biological
product. In table 1, the number of respondents is based on the
estimated number of manufacturers that are subject to those regulations
or that submitted the required information to the Center for Biologics
Evaluation and Research and Center for Drugs Evaluation and Research,
FDA, in fiscal year (FY) 2016. Based on information obtained from the
FDA's database system, there were 93 manufacturers of biological
products. This number excludes those manufacturers who produce Whole
Blood, components of Whole Blood, or in-vitro diagnostic licensed
products, because of the exemption under Sec.  600.80(m). The total
annual responses are based on the number of submissions received by FDA
in FY 2016. There were an estimated 125,371 15-day Alert reports,
180,580 periodic reports, and 677 lot distribution reports submitted to
FDA. The number of 15-day Alert reports for postmarketing studies under
Sec.  600.80(e) is included in the total number of 15-day Alert
reports. FDA received 81 requests from 40 manufacturers for waivers
under Sec.  600.90 (including Sec. Sec.  600.80(h)(2) and
600.81(b)(2)), of which 79 were granted. The hours per response are
based on FDA experience. The burden hours required to complete the
MedWatch Form (Form FDA 3500A) for Sec.  600.80(c)(1), (e), and (f) are
reported under OMB control number 0910-0291.
    In the Federal Register of July 18, 2017 (82 FR 32836), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                           Average burden
                      21 CFR Section                           Number of        responses per       Total annual     per response (in     Total hours
                                                              respondents         respondent         responses            hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
600.80(c)(1), 600.80(d), and 600.80(e); postmarketing 15-                 93           1,348.07            125,371                  1            125,371
 day Alert reports.......................................
600.82; notification of discontinuance or interruption in                 18               1.61                 29                  2                 58
 manufacturing...........................................
600.80(c)(2); periodic adverse experience reports........                 93           1,941.72            180,580                 28          5,056,240
600.81 Distribution Reports..............................                 93               7.28                677                  1                677
600.80(h)(2), 600.81(b)(2), and 600.90; waiver requests..                 40               2.03                 81                  1                 81
                                                          ----------------------------------------------------------------------------------------------
    Total................................................  .................  .................  .................  .................          5,182,427
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    In table 2 the number of respondents is based on the number of
manufacturers subject to those regulations. Based on information
obtained from FDA's database system, there were 263 licensed
manufacturers of biological products in FY 2016. However, the number of
recordkeepers listed for Sec.  600.12(a) through (e) excluding (b)(2)
is estimated to be 114. This number excludes manufacturers of blood and
blood components because their burden hours for recordkeeping have been
reported under Sec.  606.160 in OMB control number 0910-0116. The total
annual records is based on the annual average of lots released in FY
2016 (7,198), number of recalls made (575), and total number of adverse
experience reports received (305,951) in FY 2016. The hours per record
are based on FDA experience.
    FDA estimates the burden of this recordkeeping as follows:

                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                                                Average burden
                                     Number of       Number of     Total annual         per
         21 CFR Section            recordkeepers    records per       records      recordkeeper     Total hours
                                                   recordkeeper                     (in hours)
----------------------------------------------------------------------------------------------------------------
600.12 \2\; maintenance of                   114           63.14           7,198              32         230,336
 records........................
600.12(b)(2); recall records....             263            2.19             575              24          13,800
600.80(c)(1) and 600.80(k)......              93        3,289.79         305,951               1         305,951
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         550,087
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ The recordkeeping requirements in Sec.   610.18(b) are included in the estimate for Sec.   600.12.

    The burden for this information collection has changed since the
last OMB approval. Because of an increase in the number of AER reports
we have received during the past 3years, we have increased our
reporting and recordkeeping burden estimates.

    Dated: January 2, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00095 Filed 1-5-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 209 (Wednesday, October 29, 2014)]
[Notices]
[Pages 64394-64397]
[FR Doc No: 2014-25638]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1009]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Information Request
Regarding pH of Smokeless Tobacco Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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
November 28, 2014.

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:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-NEW and
title ``Information Request Regarding pH of Smokeless Tobacco
Products.'' Also include the FDA docket number found in brackets in the
heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
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.

Information Request Regarding pH of Smokeless Tobacco Products--(OMB
Control Number 0910-NEW)

    On June 22, 2009, President Obama signed the Family Smoking
Prevention and Tobacco Control Act (the Tobacco Control Act) (Pub. L.
111-31) into law. The Tobacco Control Act amended the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) by granting FDA authority to
regulate the manufacture, marketing, and distribution of tobacco
products to protect the public health generally and to reduce tobacco
use by minors.
    Section 904(b) of the FD&C Act (21 U.S.C. 387d(b)) states that at
the request of the Secretary, each tobacco product manufacturer or
importer, or agents thereof, must submit:
     Any or all documents (including underlying scientific
information) relating to research activities, and research findings,
conducted, supported, or possessed by the manufacturer (or agents
thereof) on the health, toxicological, behavioral, or physiological
effects of tobacco products and their constituents (including smoke
constituents), ingredients, components, and additives.
     Any or all documents (including underlying scientific or
financial information) relating to research activities, and research
findings, conducted, supported, or possessed by the manufacturer (or
agents thereof) that relate to the issue of whether a reduction in risk
to health from tobacco products can occur upon the employment of
technology available or known to the manufacturer.
     Any or all documents (including underlying scientific or
financial information) relating to marketing research involving the use
of tobacco products or marketing practices and the effectiveness of
such practices used by tobacco manufacturers and distributors.
    If the Secretary requests information from the manufacturer of a
tobacco product not manufactured in the United States, the importer of
the tobacco product is required to supply the information. FDA is
requesting OMB approval of an information collection under section
904(b) of the FD&C Act. To become better informed about the impact of
the use of tobacco products on the public health, FDA would request
information about the effects of product pH in smokeless tobacco
products from all tobacco product manufacturers. FDA would send letters
to tobacco product manufacturers and importers who FDA has identified
as having an obligation to respond based on information before the
Agency. The requested information would include information about
research requested under section 904(b) of the FD&C Act as well as
information to be provided voluntarily beyond the inquiries described
in section 904(b).

I. Information Requested

    The proposed request would include the following information:
    All documents (including underlying scientific information and
financial information) relating to research activities and research
findings conducted, supported, or possessed by the respondent or the
respondent's agents relating to a specified set of topics listed in
this document. The request includes but is not limited to documents
relating to research findings and activities, if any, that the
respondent possesses as the result of acquiring or merging with another
company. For purposes of the request, ``research'' would include, but
would not be limited to, focus groups, surveys, experimental clinical
studies, toxicological and biochemical assays, in vivo and in vitro
assays including animal testing, laboratory formulation and processing
testing, taste panels, and assessments of the effectiveness of product
marketing practices. The request would apply to research relating to
any and all smokeless tobacco products, including but not limited to
those products for research, investigational use, developmental
studies, test marketing, and/or commercial marketing, and also to the

components, parts, or accessories of such products. For products not
manufactured in the United States, the request would apply to the
extent the respondent has imported such products into the United
States.

II. Topics

    Under section 904(b) of the FD&C Act, FDA would request all
documents and underlying scientific and financial information relating
to research activities, research findings, and marketing research for
smokeless tobacco products developed since January 1, 1980, on the
following topics:
     The effect of product pH on ratio of free/bound
(unprotonated/protonated) nicotine;
     the effect of product pH on user behavior;
     the effect of product pH on user subjective effects and
experiences including, but not limited to, sensory effects in the mouth
and throat, liking, craving and withdrawal symptoms, stimulation,
concentration, and anxiety;
     the effect of product pH on user physiological responses
including, but not limited to, heart rate, blood pressure, temperature,
and nicotine pharmacokinetics; and
     for smokeless tobacco products that have a pH of 7.2 or
less, marketing research that includes attractiveness or appeal to new
users, inexperienced users, and/or to persons under the age of 25.
    Research and development of methodology for adjusting the pH of
smokeless tobacco products would be specifically excluded from this
904(b) request.

III. Limitations on Types of Documents and Information

    With respect to the topics listed, FDA would request only the
following documents and information:
     Study proposals, original implemented protocols (including
all amendments), analysis plans, agreements, notebooks, data collection
tools, including but not limited to, forms and assessment scales for
planned, ongoing, or completed studies, surveys, and other research,
whether for external release or internal use;
     final data analyses and reports regarding studies,
surveys, data compilations, or other research, whether for external or
internal use (if there were no final analyses, interim data analyses
would be included in the request);
     posters and/or presentations exhibited or to be exhibited
at external meetings or conferences if the underlying data has not been
presented in other documents and information within the request;
     manuscripts, articles, editorials, and letters that have
been submitted for publication but not yet published (e.g., in review,
accepted, rejected); and
     underlying data (e.g., in the form of spreadsheets,
datasets, charts, tables, and diagrams) analyzed to produce any of the
data analyses, reports, posters, manuscripts, or articles requested
previously in this notice.
    FDA would request only the final versions of documents, or in the
absence of a final version, the most recent draft of each document.
Published (i.e., publically available) press releases, abstracts,
editorials, letters, manuscripts, material safety data sheets, and
Department of Health and Human Services correspondences, would not be
requested, although FDA would appreciate a list of such publications
provided as a separate appendix. Data supporting summary reports would
be included in the request, and FDA would ask that spreadsheets or
datasets be submitted both in PDF and in a file type and structured
format that allows for meaningful review and analysis of the data
(e.g., Excel (.xls), comma separated values (.csv), or SAS transport
(.xpt) file formats). Also, FDA would request relevant data submissions
be accompanied by the name and version of the software used to create
the file, and names and definitions of variables and copies of programs
and macros needed to generate the analyses. FDA would also ask that
respondents include any data analyses that stratify scientific results
by gender, race, ethnicity, age, or other similar factors.
    To provide context and background for each document, FDA would ask
the respondent to include a load file containing metadata (e.g.,
manufacturer, date, author(s)) for each document. Also in the metadata
load file, FDA would ask the respondents to identify the presence of
each document in the University of California San Francisco Legacy
Tobacco Documents Library (LTDL) as one of the following: Present with
the Bates number (begin Bates number to end Bates number), not present,
or unknown.
    As an option, information responsive to the request that has been
previously provided to FDA under sections 904(a)(1), 904(a)(3),
904(c)(1), 904(c)(2), or 904(c)(3) of the FD&C Act would not have to be
resubmitted as long as the document was fully referenced in the
metadata load file.

IV. Additional Information

    FDA would ask the respondent to submit voluntarily the following
additional information, as applicable, to provide context and
background for FDA:
     A summary (one to five pages in length) for each of the
topics previously mentioned in this notice, that includes the number
and type of documents included, and a high level overview of the
content; and
     an explanation of the scientific and business reasons,
rationale, or justification for developing and marketing smokeless
tobacco products with different pH values, including expected and
observed perception and behavior of current and potential consumers.
    This is a new collection of information. FDA would use the
information to assess the effects of pH of smokeless tobacco products
on consumers and the public health. In the Federal Register of July 23,
2014 (79 FR 42797), FDA published a 60-day notice requesting public
comment on the proposed collection of information. Four commenters
submitted nine comments that were PRA related.
    (Comment 1) The Agency should request all document versions,
including drafts, as well as comments on those versions and reasons for
changes made in subsequent versions.
    (Response) FDA believes the request to prepare a submission that
includes drafts including related metadata will be overly burdensome
for the respondent. Additionally, a request to be provided the reason
for changes made in subsequent versions is beyond the inquiries
described in section 904(b). FDA clarified the request to note the
original implemented protocol is to be submitted. FDA would contact
manufacturers, if additional information is needed to facilitate the
Agency's review of the submission.
    (Comment 2) Do not limit the request to SAS datasets as to not
exclude other statistical software.
    (Response) It is FDA's intent that data not be excluded from the
request based upon the statistical analysis software used. The proposed
request asks that data be provided in a file type and structured format
that allows for meaningful review and analysis of the data. The request
was clarified to note that SAS.xpt is a recommended format for
datasets.
    (Comment 3) The Agency should request the LTDL tobacco
identification (TID) number or URL since these are unique to the
document.
    (Response) Because the manufacturer does not assign the TID number
or URL, FDA believes requesting this information would be overly
burdensome for the respondent and

therefore would request only the Bates number(s) as proposed, given
that this information is assigned by the manufacturer.
    (Comment 4) It would be overly burdensome for the respondent to
locate data and provide the requested software for information dating
back to January 1, 1970, and FDA should focus the information for more
recent times.
    (Response) FDA believes the time period for this request should
coincide with the commercial availability of smokeless tobacco products
with different pH values because industry research on this topic is
limited in the public domain. FDA has considered the scientific value
of the data and information as well as the burden on respondents to
provide such information to FDA. Therefore, FDA revised the request to
ask for documents developed since January 1, 1980.
    (Comment 5) The burden for the collection was underestimated given
that it is likely older documents may only exist in hard copy and, if
found, would be in remote storage that would be mostly searched
manually.
    (Response) The burden was revised given that this portion of the
request may be performed manually.
    (Comment 6) The burden for the collection was underestimated given
that respondents would need to perform document-by-document search of a
third party site to provide the requested metadata from LTDL.
    (Response) The burden was revised given that this portion of the
request may be performed manually.
    (Comment 7) It would be overly burdensome for respondents to
provide the amount of metadata requested for documents previously
submitted to FDA in lieu of providing the Agency with all of the
responsive documents it locates.
    (Response) FDA clarified the purpose of the metadata load file and
also clarified that the respondent has the option to provide metadata
for previously submitted documents.
    (Comment 8) It would take at least 90 days to provide a response to
the request.
    (Response) Given the Agency's experience with previous submissions
under section 904(a)(4) and 904(b) of the FD&C Act, FDA would request a
response within 60 days from the date of the letter and request
respondents that anticipate difficulties with the document production
to contact FDA within 30 days of the date of the letter. FDA will
provide assistance in resolving any technical difficulties and
facilitate compliance with the timeline.
    (Comment 9) The Agency previously estimated an average of 200 hours
per response for the Agency's request for dissolvable tobacco products
in 2011.
    (Response) FDA has since learned from experience with document
submissions under section 904(a)(4) and 904(b) of the FD&C Act that
some respondents have electronic document systems. Thus, estimates for
this collection reflect automation capabilities for processing and
managing document submissions.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Number of                        Average
  Type of respondent gathering  product pH information       Number of     responses per   Total annual    burden hours     Total hours    Total capital
                                                            respondents     respondent       responses     per response                        costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tobacco product manufacturers and importers with LTDL                  3               1               3             165             495             $29
 collections............................................
Additional tobacco product manufacturers and importers                 3               1               3             175             525             186
 with previous submissions to FDA.......................
Other manufacturers who have no documents, do not                    119               1             119               5             595              59
 manufacture smokeless tobacco products, or do not
 anticipate manufacturing these products................
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............           1,615             274
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.

    We estimate the capital costs associated with this document to be
$274. This estimate is based upon: (1) 3 Submissions being submitted by
mailing an average of 10 CDs per envelope ($29), (2) 3 submissions
being submitted by mailing a package of paper documents weighing an
average of 50 pounds total ($186), and (3) 119 submissions of 1
business class letter describing that no documents are available (119 x
$0.49 (the price of a first class business stamp), or $59).
    FDA is drawing from tobacco health document submissions under
section 904(a)(4) and 904(b) of the FD&C Act, our interaction with the
public, and our experience to inform the burden estimates associated
with this information collection. Additionally, based upon comments in
response to the Federal Register notice, FDA is revising its initial
estimates of annualized burden hours.
    FDA estimates the burden for this collection of information to be
1,615 hours. FDA estimates it will receive 125 submissions. Based upon
the expected number of tobacco product manufacturers and importers,
their burden has been broken into three tiers:
     FDA anticipates documents for this request will be
submitted by three tobacco product manufacturers and importers that
have document collections within LTDL. Manufacturers one through three
were estimated to take 201, 206, and 85 hours respectively, for an
approximate average of 165 hours per response, to process and prepare a
submission (i.e., cover letter, documents and information, and metadata
load file). Total burden hours for this portion of the collection are
expected to be 495 hours.
     FDA anticipates documents to also be submitted by three
additional tobacco product manufacturers and importers that provided
health documents under section 904(a)(4). Manufacturers four through
six were estimated to take 304, 118, and 91 hours respectively, for an
approximate average of 175 hours per response, to process and prepare a
submission (i.e., cover letter, documents and information, and metadata
load file). Total burden hours for this portion of the collection are
expected to be 525 hours.
     FDA estimates that 119 manufacturers and importers will
not possess documents responsive to this request. These manufacturers
do not have documents, do not manufacture smokeless tobacco products,
or do not

anticipate manufacturing these tobacco products and are estimated to
take approximately 5 hours each to conduct a review of their records,
draft and send a letter to FDA indicating that they do not have
documents to submit. Total burden hours for this portion of the
collection are expected to be 595 hours.

    Dated: October 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-25638 Filed 10-28-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: August 12, 2009 (Volume 74, Number 154)]
[Notices]
[Page 40633]
[DOCID:fr12au09-107]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

Notice of Applications for Certificates of Public Convenience and
Necessity and Foreign Air Carrier Permits Filed Under Subpart B
(Formerly Subpart Q) During the Week Ending August 1, 2009

    The following Applications for Certificates of Public Convenience
and Necessity and Foreign Air Carrier Permits were filed under Subpart
B (formerly Subpart Q) of the Department of Transportation's Procedural
Regulations (See 14 CFR 301.201 et seq.). The due date for Answers,
Conforming Applications, or Motions to Modify Scope are set forth below
for each application. Following the Answer period DOT may process the
application by expedited procedures. Such procedures may consist of the
adoption of a show-cause order, a tentative order, or in appropriate
cases a final order without further proceedings.
    Docket Number: DOT-OST-2007-0066.
    Date Filed: July 29, 2009.
    Due Date for Answers, Conforming Applications, or Motion to Modify
Scope: August 19, 2009.
    Description: Application of Hainan Airlines Co., Limited (``Hainan
Airlines'') requesting that the Department amend its foreign air
carrier permit to enable it to engage in scheduled air transportation
of persons, property and mail between Beijing, People's Republic of
China (PEK), on the one hand, and Honolulu, Hawaii (HNL), on the other
hand. Hainan Airlines also requests exemption authority to the extent
necessary so that it may exercise the rights requested in this
application prior to the issuance of an amended foreign air carrier
permit.

 Renee V. Wright,
Program Manager, Docket Operations, Federal Register Liaison.
[FR Doc. E9-19369 Filed 8-11-09; 8:45 am]

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