  SEQ CHAPTER \h \r 1 SUPPORTING STATEMENT

ENVIRONMENTAL PROTECTION AGENCY

	NSPS for Fossil Fuel Fired Steam Generating Units

1.  Identification of the Information Collection

	1(a)  Title of the Information Collection

	NSPS for Fossil-Fuel-Fired Steam Generating Units (40 CFR part 60,
subpart D) (Renewal)

	1(b)  Short Characterization/Abstract

	 The New Source Performance Standards (NSPS) for Fossil-Fuel-Fired
Steam Generating Units, 40 CFR part 60, subpart D, proposed on August
17, 1971, and promulgated on December 23, 1971, apply to emissions from
each fossil-fuel-fired steam generating unit of more than 73 megawatts
heat input rate (250 mmBtu/hr), which commenced construction,
modification, or reconstruction after August 17, 1971.  Subpart D
regulations apply to both electric utility and industrial boilers.  This
regulation was supplanted by NSPS subpart Da for electric utility steam
generating units in 1978, and for industrial-institutional-commercial
boilers in 1986.  Since then, no new subpart D units have been
constructed.  The United States Environmental Protection Agency (EPA)
performs this information collection to assure compliance with 40 CFR
part 60, subpart D.

	In general, all NSPS standards require initial notifications,
performance tests, and periodic reports.  Owners or operators are also
required to maintain records of the occurrence and duration of any
startup, shutdown, or malfunction in the operation of an affected
facility, or any period during which the monitoring system is
inoperative.  These notifications, reports, and records are essential in
determining compliance, and are required of all sources subject to NSPS.

	Any owner or operator subject to the provisions of this part shall
maintain a file of these measurements, and retain the file for at least
two years following the date of such measurements, maintenance reports,
and records.  All reports (one-time, and periodic reports such as excess
emission reports required semiannually) 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 United States
Environmental Protection Agency (EPA) regional office.  The state or EPA
offices use the reports to determine compliance with NSPS subpart D.

	Approximately 660 sources are currently subject to the regulation.
Because electric utility boilers constructed after September 1978 are
subject to subpart Da, and industrial, commercial, and institutional
boilers constructed after June 19, 1986, are subject to subpart Db,
there have not been any new subpart D units since 1986 and there will be
no new units in the future.  The cost of this Information Collection
Request (ICR) will be $9,900,000.  The Office of Management and Budget
(OMB) approved the currently active ICR without any “Terms of
Clearance”.

2.  Need for and Use of the Collection

	2(a)  Need/Authority for the Collection

	The EPA is charged under section 111 of the Clean Air Act (CAA), as
amended, to establish standards of performance for new stationary
sources that reflect:

. . . application of the best technological system of continuous
emissions reduction which (taking into consideration the cost of
achieving such emissions reduction, or any non-air quality health and
environmental impact and energy requirements) the Administrator
determines has been adequately demonstrated.  Section 111(a)(l).

The Agency refers to this charge as selecting the best demonstrated
technology (BDT).  Section 111 also requires that the Administrator
review and, if appropriate, revise such standards every four years.

	In addition, section 114(a) states that the Administrator may require
any owner or operator subject to any requirement of this Act to:

(A) Establish and maintain such records; (B) make such reports; (C)
install, use, and maintain such monitoring equipment, and use such audit
procedures, or methods; (D) sample such emissions (in accordance with
such procedures or methods, at such locations, at such intervals, during
such periods, and in such manner as the Administrator shall prescribe);
(E) keep records on control equipment parameters, production variables
or other indirect data when direct monitoring of emissions is
impractical; (F) submit compliance certifications in accordance with
Section 114(a)(3); and (G) provide such other information as the
Administrator may reasonably require.

	In the Administrator's judgment, sulfur dioxide (SO2), particulate
matter (PM), and nitrogen oxides (NOx) emissions from fossil-fuel-fired
steam generating units cause or contribute to air pollution that may
reasonably be anticipated to endanger public health or welfare.
Therefore, the NSPS were promulgated for this source category at 40 CFR
part 60, subpart D.

	2(b)  Practical Utility/Users of the Data

Adequate monitoring, recordkeeping, and reporting are necessary to
ensure compliance with the applicable regulations, as required by the
Clean Air Act.  The information collected from recordkeeping and
reporting requirements is used for certifying compliance with the
emission limits, monitoring, personnel training and other requirements,
targeting inspections, assessing compliance trends, evaluating the
efficacy of the promulgated regulations, and as evidence in court.

Performance tests are required in order to determine an affected
facility’s ability to comply with the emission standards.  The
performance stack test usually requires three 1-hour test runs using the
EPA reference test method to demonstrate compliance.  Subpart D requires
only one performance test (the initial compliance stack test).
Continuous emission monitors are required to ensure compliance with the
standards at all times.

The notifications required in the applicable regulations are used to
inform the Agency or delegated authority when a source becomes subject
to the requirements of the regulations.  The reviewing authority may
then inspect the source to check if the pollution control devices are
properly installed and operated, and if the facility is in compliance
with the standards and other requirements.  Performance test reports are
needed as these are the Agency's record of a source's initial capability
to comply with the emission standards, and serve as a record of the
operating conditions under which compliance was achieved.  The
semiannual excess emission reports are used to determine excess
emissions, identify problems at the facility, check the source operation
and maintenance, and for compliance determinations.  The reported
information is also used in enforcement actions against the violators.

3.  Nonduplication, Consultations, and Other Collection Criteria

	The requested recordkeeping and reporting are required under 40 CFR
part 60, subpart D.

	3(a)  Nonduplication

	 If the subject standards have not been delegated, the information is
sent directly to the appropriate EPA regional office.  Otherwise, the
information is sent directly to the delegated state or local agency.  If
a state or local agency has adopted their own similar standards to
implement the Federal standards, a copy of the report submitted to the
state or local agency can be sent to the Administrator in lieu of the
report required by the Federal standards.  Therefore, no duplication
exists.

	3(b)  Public Notice Required Prior to ICR Submission to OMB

	An announcement of a public comment period for the renewal of this ICR
was published in the Federal Register on June 21, 2006 (FR 71, 35652).
No comments were received on the burden published in the Federal
Register.

	3(c)  Consultations

	EPA published an announcement of a public comment period for the
renewal of this ICR in the Federal Register on June 21, 2006.  No
comments were received on respondent burden associated with the
reporting and recordkeeping requirements provided in this ICR.  We
assumed that the number of subjected boilers has not changed since the
last ICR (no new boilers, and no shutdowns or modifications of the
relatively recent boilers under subpart D).

	3(d)  Effects of Less Frequent Collection

	Less frequent information collection would decrease the margin of
assurance that facilities are continuing to meet the standards.
Requirements for information gathering and recordkeeping are useful
techniques to ensure that good operation and maintenance practices are
applied and emission limitations are met.  If the information required
by these standards was collected less frequently, the proper operation
and maintenance of control equipment and monitors and the possibility of
detecting violations would be less likely.

3(e)  General Guidelines

	None of these reporting or recordkeeping requirements violate any of
the regulations established by OMB at 5 CFR 1320.5.

	3(f)  Confidentiality

	The required information has been determined not to be confidential.
However, any information submitted to the Agency for which a claim of
confidentiality is made will be safeguarded according to the Agency
policies set forth in Title 40, Chapter 1, part 2, subpart B -
Confidentiality of Business Information (CBI) (see 40 CFR 2; 41 FR
36902, September 1, 1976; amended by 43 FR 40000, September 8, 1978; 43
FR 42251, September 20, 1978; and 44 FR 17674, March 23, 1979).

3(g)  Sensitive Questions

None of the reporting or recordkeeping requirements contain sensitive
questions.

The Respondents and the Information Requested

4(a)  Respondents/SIC Codes

The respondents to the recordkeeping and reporting requirements are
fossil-fuel-fired steam generating units that commenced construction,
modification, or reconstruction after August 17, 1971, and that have a
heat input capacity of greater than 73 MW (250 mmBtu/hr).  The Standard
Industrial Classification (SIC) codes and corresponding North American
Industry Classification System (NAICS) are listed below.

Regulation	SIC Codes	NAICS Codes

40 CFR part 60, subpart D	1531	23332

	2033	311421

	Major Group 22	Major Group 313

	Major Group 24	Major Group 321

	2611	322110

	Major Group 28	Major Group 325

	2911	324110

	Major Group 30	Major Group 326

	Major Group 33	Major Group 331

	Major Group 34	Major Group 332

	Major Group 37	Major Group 336

	4911	221112

	7299	81299

	4(b)  Information Requested

	(i)  Data Items

All data in this ICR that is recorded and/or reported is required by
NSPS, Standards of Performance for Fossil-Fuel-Fired Steam Generating
Units, 40 CFR part 60, subpart D.

	A source must make the following notifications/reports :

Reports for 40 CFR part 60, subpart D

Construction/reconstruction date 	60.7(a)(1)

Actual startup date 	60.7(a)(3)

Initial performance test results 	60.8 (a)

Initial performance test 	60.8(d)

Demonstration of continuous monitoring system 	60.7(a)(5)

Opacity test notification	60.7(a)(6)

Physical or operational change 	60.7(a)(4)

Excess emissions and monitoring system performance semiannual report
60.7(c), 60.45(g)

A source must maintain the following records:

Recordkeeping for 40 CFR part 60, subpart D

Startups, shutdowns, malfunctions, periods where the continuous
monitoring system is inoperative.	60.7(b)

Records are required to be retained for 2 years at the facility.	60.7(f)

		(ii) Respondent Activities

Respondent Activities

Read instructions.

Install, certify, maintain, and operate Continuous Monitoring System
(CMS) for opacity, SO2, NOx and either O2 or CO2 or a fuel sampling and
analysis system

Perform initial performance test to demonstrate compliance.

Write the notifications and reports listed above.

Enter information required to be recorded above.

Submit the required reports developing, acquiring, installing, and
utilizing technology and systems for the purpose of collecting,
validating, and verifying information.

Develop, acquire, install, and utilize technology and systems for the
purpose of processing and maintaining information.

Develop, acquire, install, and utilize technology and systems for the
purpose of 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.

Transmit, or otherwise disclose the information.

Subpart D requires hard copy reports.

5  The Information Collected: Agency Activities, Collection Methodology,
and Information Management

5(a)  Agency Activities

EPA conducts the following activities in connection with the
acquisition, analysis, storage, and distribution of the required
information.

Agency Activities

Observe initial performance tests.

Review notifications and reports, including performance test reports,
and excess emissions reports, required to be submitted by industry.

Audit facility records.

Input, analyze, and maintain data in the AIRS Facility Subsystem (AFS)
database.

5(b)  Collection Methodology and Management

Following notification of startup, the reviewing authority might inspect
the source to determine whether the pollution control devices are
properly installed and operated.  Performance test reports are used by
the Agency to discern a source’s initial capability to comply with the
emission standards.  Data and records maintained by the respondents are
tabulated and published for use in compliance and enforcement programs.
The semiannual reports are used for problem identification, as a check
on source operation and maintenance, for compliance determinations and,
in enforcement actions.

Information contained in the reports is entered into AFS which is
operated and maintained by EPA's Office of Air Quality Planning and
Standards.  AFS is EPA’s database for the collection, maintenance, and
retrieval of compliance and annual emission inventory data for over
100,000 industrial and government-owned facilities.  EPA uses AFS for
tracking air pollution compliance and enforcement by local and state
regulatory agencies, EPA regional offices, and EPA headquarters.  EPA
and its delegated Authorities can edit, store, retrieve and analyze the
data.

	 The records required by this regulation must be retained by the owner
or operator for two years.

5(c)  Small Entity Flexibility

	There are no small businesses affected by this regulation.

	5(d)  Collection Schedule

	The specific frequency for each information collection activity within
this request is shown in Table 2: Annual Burden of Recordkeeping and
Reporting Requirements as a Result of the Standards for Fossil Fuel
Fired Steam Generating Units, NSPS subpart D.

6.  Estimating the Burden and Cost of the Collection

	Table 1 documents the computation of individual burdens for the
recordkeeping and reporting requirements applicable to the industry for
the subpart included in this ICR.  The individual burdens are expressed
under standardized headings believed to be consistent with the concept
of burden under the Paperwork Reduction Act.  Where appropriate,
specific tasks and major assumptions have been identified.  Responses to
this information collection are mandatory.

	The 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.

	6(a)  Estimating Respondent Burden

	The average annual burden to industry over the next three years from
these recordkeeping and reporting requirements is estimated to be 61,545
person hours (Total Labor Hours from Table 1).  These hours are based on
Agency studies and background documents from the development of the
regulation, Agency knowledge and experience with the NSPS program, the
previously approved ICR, and any comments received.

	6(b)  Estimating Respondent Costs

		(i)  Estimating Labor Costs

	This ICR uses a technical labor rate of $57.12 per hour.  These rates
are from the United States Department of Labor, Bureau of Labor
Statistics, March 2001, Table 10: Private industry, by occupational and
industry group.  The rates are from column 1, “Total compensation.”
The wage rate of $27.20 has been increased by 110 percent to account for
the benefit packages available to those employed by private industry for
a labor rate of $57.12 per hour.

		(ii)  Estimating Capital/Startup and Operation and Maintenance Costs

	The type of industry costs associated with the information collection
activity in the regulations are for labor and continuous emission
monitoring (CEM).  The capital/startup costs are one-time costs when a
facility becomes subject to the regulation.  The annual operation and
maintenance costs are the ongoing costs to maintain the monitor and
other costs such as photocopying and postage.

		(iii)  Capital/Startup vs. Operation and Maintenance (O&M) Costs

Capital/Startup vs. Operation and Maintenance (O&M) Costs

(A)

Continuous Monitoring Device	(B)

Startup Cost ($) for One Affected Facility	(C)

Number of New Affected Facilities to Startup	(D)

Total Startup Costs

(B X C)	(E)

Annual O&M Costs ($) for One Affected Facility	(F)

Number of Affected Facilities with O&M	(G)

Total O&M

(E X F)

SO2, PM, and NOx	$200,000	0	$0	$15,000	660	$9,900,000

There are no total capital/startup costs for this ICR, because electric
utility boilers constructed after September 1978 are subject to subpart
Da, and industrial/commercial/institutional boilers constructed after
June 19, 1986, are subject to subpart Db, and no new steam generating
units will become subject to subpart D.  This is the total of column D
in the above table.

	The total operation and maintenance (O&M) costs for this ICR of
$9,900,000.

	The average annual cost for capital/startup and operation and
maintenance costs to industry over the next three years of the ICR is
estimated to be $9,900,000.

	6(c)  Estimating Agency Burden and Cost

	The only costs to the Agency are those costs associated with analysis
of the reported information.  Publication and distribution of the
information are part of the AFS program.  Examination of records to be
maintained by the respondents will occur as part of the periodic
inspection of sources, which is part of EPA's overall compliance and
enforcement program.

	The average annual Agency cost during the three years of the ICR is
estimated to be $125,702 [(See Table 2 in Section 6(e), attached].  This
cost is based on the average hourly labor rate at a GS-12, Step 1
employee rate times 1.6 benefits multiplication factor to account for
government overhead expenses for a total of $38.30 ($23.94 x 1.6).

	These rates are from the Office of Personnel Management (OPM) “2002
General Schedule,” which excludes locality rates of pay.  Details upon
which this estimate is based appear in Table 2: Average Annual EPA
Resource Requirement for Fossil Fuel-Fired Steam Generating Units/ NSPS
subpart D.

	6(d)  Estimating the Respondent Universe and Total Burden and Costs

	Approximately 660 sources are currently subject to the regulation and
no additional sources will become subject to the regulation in the next
three years (See Section 1(b)).

Respondent Universe and Number of Responses Per Year

Regulation Citation	(A)

Average Number of New Respondents per Year	(B)

Number of Reports for New Sources	(C)

Number of Existing Respondents	(D)

Number of Reports for Existing Sources	(E)

Number of Respondents that keep records but do not submit reports	(F)

Total Annual Responses =

(AxB)+(CxD)+ E

40 CFR 60, subpart D	0	0	660	2	0	1,320

	The number of total respondents is 660.  This number is the sum of
column A and column C of the Respondent Universe and Number of Responses
Per Year table.  This represents the number of existing sources plus the
number of new sources averaged over the three-year period.

	The number of Total Annual Responses is 1,320.  This is the number in
column E of the Respondent Universe and Number of Responses Per Year
table.

	The total annual labor costs are $3,515,450.  Details upon which this
estimate is based appear in Table 1: Annual Burden of Reporting and
Recordkeeping Requirements as a Result of the Standards for Fossil
Fuel-Fired Steam Generating Units/NSPS subpart D (attached).

	The total annual capital and O&M costs to the regulated entities are
$9,900,000.  These costs are detailed in section 6(b)(iii),
Capital/Startup vs. Operating and Maintenance (O&M) Costs.

	6(e)  Bottom Line Burden Hours Burden Hours and Cost Tables

	The bottom line burden hours and cost tables for both the Agency and
the respondents appear below.  The annual public reporting and
recordkeeping burden for this collection of information is estimated to
average 46.6 hours per response.

6(f)  Reasons for Change in Burden

There is no change in burden.  There is no change in the labor hours or
cost in this ICR compared to the previous ICR.  This is due to two
considerations.  First, the regulations have not changed over the past
three years and are not anticipated to change over the next three years.
 Secondly, the growth rate for the industry is nonexistent, so there is
no change in overall burden.

Since there are no changes in the regulatory requirements and there is
no significant industry growth, the labor hours and cost figures in the
previous ICR are used in this ICR and there is no change in burden to
industry.

	6(g)  Burden Statement

	The annual public reporting and recordkeeping burden for this
collection of information is estimated to average 46.6 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.

	To comment on the Agency's need for this information, the accuracy of
the provided burden estimates, and any suggested methods for minimizing
respondent burden, including the use of automated collection techniques,
EPA has established a public docket for this ICR under Docket ID Number
EPA-HQ-OECA-2006-0426.  An electronic version of the public docket is
available at http://www.regulations.gov/ which may be used to obtain a
copy of the draft collection of information, to submit or view public
comments, to access the index listing of the contents of the 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 in this document.  The documents are
also available for public 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<PHONE_NUMBER>, and the telephone number for the
docket center is<PHONE_NUMBER>.  Also, you can send comments to the
Office of Information and Regulatory Affairs, Office of Management and
Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk
Officer for EPA.  Please include the EPA Docket ID Number
EPA-HQ-OECA-2006-0426 and OMB Control Number 2060-0026 in any
correspondence.

NOTE:  The EPA Docket  Center suffered damage due to flooding during he
last  week of

June 2006.  The Docket Center is continuing to operate.  However, during
the cleanup, there

 will be temporary changes to Docket  Center telephone numbers,
addresses, and hours of

operation by people who wish to visit the Public Reading Room to view
documents.  Consult

EPA’s Federal Register notice at 71 FR 38147 (July 15, 2006) or the
EPA website at

www.epa.gov/epahome/dockets .htm for current information on docket
status; locations and

telephone numbers.

Part B of the Supporting Statement

	This part is not applicable because no statistical methods were used in
collecting this information.

TABLE 1.  ANNUAL BURDEN OF REPORTING AND RECORDKEEPING REQUIREMENTS AS
A RESULT OF THE STANDARDS FOR FOSSIL FUEL-FIRED STEAM GENERATING
UNITS/NSPS SUBPART D.

	 	A	B	C	D	E	F

Reporting and recordkeeping requirements	Person hours per occurrence
Annual occurrences per    respondent	Annual person hours/respondent
(A x B)	Total number of respondents	Total annual person hours    (C x
D)	Total annual cost   (E x $57.12)

1. APPLICATIONS	............................not
applicable.........................

2. SURVEYS AND STUDIES	............................not
applicable.........................

3. REPORTING REQUIREMENTS

a. Read instructions	No new sources will become subject, therefore not
applicable

b. Required activites

          Initial Performance Test

c. Create information

d. Gather Existing Information	Included in 3E

e. Write report

          Notification of const/reconstruction 	No new sources will
become subject, therefore not applicable

          Notification of ant/ act.startup

          Notify of emission test

          Report of initial emission test

          Excess emissions report	1	2	2	660	1320	$75,398.40

4. RECORD KEEPING REQUIREMENTS

a. Read instructions	Included in 3A

b. Plan Activites	Included in 4C

c. Implement Activities	Included in 3B

d. Develop Record System	N/A

e. Time to check computer system and calibrate continuous monitors	0.25
365	91.25	660	60,225	$3,440,052

f. Time to Train Personnel	N/A

g. Time For Audits	N/A

TOTAL: ANNUAL BURDEN	 	 	 	 	61,545	$3,515,450

	a) Assume an hourly wage of $57.12 ($27.20 + 110% to account for the
benefit packages available to those employed by private industry).  This
amount was multiplied by the hours per year in column E.

	b) Assume operation 365 days per year.

TABLE 2.  AVERAGE ANNUAL EPA RESOURCE REQUIREMENT FOR FOSSIL FUEL-FIRED
STEAM GENERATING UNITS/NSPS SUBPART D.

	 	A	B	C	D	E	F

 	EPA hours per occurrence	Occurrences per plant/yr	EPA
hours/plant/yr     (A x B)	Plants/year	EPA           hours/year    (C x
D)	Total annual cost   (E x $38.30)

Report Review For Construction, Anticipated Startup, Actual Startup

Review Notification of Initial Test:

     Sulfur Dioxide

     Particulate Matter

     Nitrogen Oxides

Review Initial Test Results:

     Sulfur Dioxide

     Particulate Matter

     Nitrogen Oxides

Review Notification of CMS Demonstration:

     Sulfur Dioxide

     Particulate Matter

     Nitrogen Oxides

Review CMS Performance Demonstration:

     Sulfur Dioxide

     Particulate Matter

     Nitrogen Oxides

Review Excess Emission Reports (d)	1	2	2	460	920	$35,236

Review SO2 compliance Reports (d), (e)

     Coal-fired units	2	4	8	180	1,440	$55,152

     Oil-fired units	2	4	8	92	736	$28,189

TOTAL:	 	 	 	 	3,096	$118,577

Travel Expenses (d) (1 person x 15 plants/yr x  3 days/plant x $75 per
diem) + ($250 round trip/plant x 15 plants/yr) = 	 	 	 	 	 	$7,125

TOTAL ANNUAL COST	 	 	 	 	 	$125,702

	a) A X B = C

	b) C X D = E

	c) Assume an hourly wage of a GS12, Step 1 employee rate times a 1.6
benefits multiplication factor to account for government overhead
expenses for a total of $38.30. This amount was multiplied by the hours
in each line of Column E to estimate the total annual cost per year.

	d) Assume approximately 70% of the sources monitor via CEM.
Approximately 30% use fuel sampling and analysis.

	e) Units using fuel sampling and analysis submit these reports instead
of excess emission reports based on CEM data.  Figures used in this
category are based on research performed during regulation revision.

 PAGE   10

 PAGE   15


[Federal Register Volume 82, Number 136 (Tuesday, July 18, 2017)]
[Notices]
[Pages 32834-32835]
[FR Doc No: 2017-14996]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0598]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Current Good
Manufacturing Practice Regulations for Type A Medicated Articles

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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 August
17, 2017.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0154.
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, 10A63, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<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.

Current Good Manufacturing Practice Regulations for Type A Medicated
Articles--21 CFR Part 226 OMB Control Number 0910-0154--Extension

    Under section 501 of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act), FDA has the statutory authority to issue current good
manufacturing practice (cGMP) regulations for drugs, including Type A
medicated articles. A Type A medicated article is a feed product
containing a concentrated drug diluted with a feed carrier substance. A
Type A medicated article is intended solely for use in the manufacture
of another Type A medicated article or a Type B or Type C medicated
feed. Medicated feeds are administered to animals for the prevention,
cure, mitigation, or treatment of disease or for growth promotion and
feed efficiency.
    Statutory requirements for cGMPs for Type A medicated articles have
been codified in part 226 (21 CFR part 226). Type A medicated articles,
which are not manufactured in accordance with these regulations, are
considered adulterated under section 501(a)(2)(B) of the FD&C Act (21
U.S.C. 351(a)(2)(B)). Under part 226, a manufacturer is required to
establish, maintain, and retain records for Type A medicated articles,
including records to document procedures required under the
manufacturing process to assure that proper quality control is
maintained. Such records would, for example, contain information
concerning receipt and inventory of drug components, batch production,
laboratory assay results (i.e., batch and stability testing), and
product distribution.
    The required records are used by both the respondents and FDA. The
records are used by manufacturers of Type A medicated articles to
verify that appropriate control measures have been maintained, or that
appropriate corrective actions were taken if the control measures were
not maintained. Such verification activities are essential to ensure
that the cGMP system is working as planned. We review the records
during the conduct of periodic plant inspections. This information is
needed so that we can monitor drug usage and possible misformulation of
Type A medicated articles. The information could also prove useful to
us in investigating product defects when a drug is recalled. In
addition, we will use the cGMP criteria in part 226 to determine
whether or not the systems used by manufacturers of Type A medicated
articles are adequate to assure that their medicated articles meet the
requirements of the FD&C Act as to safety and also meet the article's
claimed identity, strength, quality, and purity, as required by section
501(a)(2)(B) of the FD&C Act. The respondents for Type A medicated
articles are pharmaceutical firms that manufacture both human and
veterinary drugs, those firms that produce only veterinary drugs, and
commercial feed mills.
    In the Federal Register of October 17, 2016 (81 FR 71513), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received no comment. FDA estimates the
burden of this collection of information as follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                                Noumber of
               21 CFR section                    Number of      records per    Total annual        Average burden per  recordkeeping        Total hours
                                               recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
226.42, requires records be prepared and                  65             260          16,900  0.75 (45 minutes).........................          12,675
 maintained for 2 years with respect to
 components (drug and non-drug) used in the
 manufacture of the medicated premixes.
226.58, requires recordkeeping for                        65             260          16,900  1.75......................................          29,575
 establishment of laboratory controls to
 ensure that adequate specifications and
 test procedures for the drug components and
 Type A medicated articles conform to
 appropriate standards of identity,
 strength, quality, and purity.
226.80, requires maintenance of records for               65             260          16,900  0.75 (45 minutes).........................          12,675
 packaging and labeling of Type A medicated
 articles.
226.102, requires maintenance of master-                  65             260          16,900  1.75......................................          29,575
 formula and batch-production records for
 Type A medicated articles.
226.110, requires maintenance of                          65             260          16,900  .25 (15 minutes)..........................           4,225
 distribution records (2 years) for each
 shipment of Type A medicated articles for
 recall purposes.
226.115, requires maintenance of complaint                65              10             650  .5 (30 minutes)...........................             325
 files for Type A medicated articles for 2
 years.
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................         76, 375
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We based our estimate of the time required for record preparation
and maintenance on our communications with industry. We derived
additional information needed to calculate the total burden hours
(i.e., manufacturing sites, number of Type A medicated articles being
manufactured, etc.) from our records and experience. The burden has not
changed since the last OMB approval.

    Dated: July 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-14996 Filed 7-17-17; 8:45 am]
 BILLING CODE 4164-01-P