Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals, 66724-66728 [2014-26596]
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Federal Register / Vol. 79, No. 217 / Monday, November 10, 2014 / Notices
medicine, public health, biological and
physical sciences, epidemiology and
biostatistics, clinical trial design, health
care data management and analysis,
patient advocacy, health care
economics, medical ethics or other
relevant professions.
The MEDCAC works from an agenda
provided by the Designated Federal
Official. The MEDCAC reviews and
evaluates medical literature and
technology assessments, and hears
public testimony on the evidence
available to address the impact of
medical items and services on health
outcomes of Medicare beneficiaries. The
MEDCAC may also advise the Centers
for Medicare & Medicaid Services (CMS)
as part of Medicare’s ‘‘coverage with
evidence development’’ initiative.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
II. Provisions of the Notice
As of June 2015, there will be 16
membership terms expiring. Of the 16
memberships expiring, 2 are industry
representatives, 1 is a patient advocate,
and the remaining 13 membership
openings are for the at-large standing
MEDCAC membership.
We wish to ensure adequate
representation of the interests of both
women and men, members of all ethnic
groups and physically challenged
individuals. Therefore, we encourage
nominations of qualified candidates
from these groups.
All nominations must be
accompanied by curricula vitae.
Nomination packages should be sent to
Maria Ellis at the address listed in the
ADDRESSES section of this notice.
Nominees are selected based upon their
individual qualifications. Nominees for
membership must have expertise and
experience in one or more of the
following fields:
• Clinical medicine including
subspecialties
• Administrative medicine
• Public health
• Biological and physical sciences
• Epidemiology and biostatistics
• Clinical trial design
• Health care data management and
analysis
• Patient advocacy
• Health care economics
• Medical ethics
• Other relevant professions
We are looking particularly for
experts in a number of fields. These
include cancer screening, genetic
testing, clinical epidemiology,
psychopharmacology, screening and
diagnostic testing analysis, and vascular
surgery. We also need experts in
biostatistics in clinical settings,
dementia treatment, minority health,
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observational research design, stroke
epidemiology, and women’s health.
The nomination letter must include a
statement that the nominee is willing to
serve as a member of the MEDCAC and
appears to have no conflict of interest
that would preclude membership. We
are requesting that all curricula vitae
include the following:
•
•
•
•
•
•
•
•
•
Date of birth
Place of birth
Social security number
Title and current position
Professional affiliation
Home and business address
Telephone and fax numbers
Email address
List of areas of expertise
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Current Good
Manufacturing Practice Regulations for
Finished Pharmaceuticals
AGENCY:
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program.)
Fmt 4703
BILLING CODE 4120–01–P
[Docket No. FDA–2011–N–0362]
Authority: 5 U.S.C. App. 2, section 10(a)(1)
and (a)(2).
Frm 00042
[FR Doc. 2014–26699 Filed 11–7–14; 8:45 am]
Food and Drug Administration
In the nomination letter, we are
requesting that nominees specify
whether they are applying for a patient
advocate position, for an at-large
standing position, or as an industry
representative. Potential candidates will
be asked to provide detailed information
concerning such matters as financial
holdings, consultancies, and research
grants or contracts in order to permit
evaluation of possible sources of
financial conflict of interest. Department
policy prohibits multiple committee
memberships. A federal advisory
committee member may not serve on
more than one committee within an
agency at the same time.
Members are invited to serve for
overlapping 2-year terms. A member
may continue to serve after the
expiration of the member’s term until a
successor is named. Any interested
person may nominate one or more
qualified persons. Self-nominations are
also accepted. Individuals interested in
the representative positions must
include a letter of support from the
organization or interest group they
would represent. The current
Secretary’s Charter for the MEDCAC is
available on the CMS Web site at:
https://www.cms.hhs.gov/FACA/
Downloads/medcaccharter.pdf, or you
may obtain a copy of the charter by
submitting a request to the contact listed
in the FOR FURTHER INFORMATION
CONTACT section of this notice.
PO 00000
Dated: November 4, 2014.
Patrick Conway,
Deputy Administrator for Innovation and
Quality and CMS Chief Medical Officer,
Centers for Medicare & Medicaid Services.
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the current good manufacturing practice
(CGMP) regulations for finished
pharmaceuticals.
DATES: Submit either electronic or
written comments on the collection of
information by January 9, 2015.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA 305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
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, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
SUMMARY:
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Federal Register / Vol. 79, No. 217 / Monday, November 10, 2014 / Notices
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information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Current Good Manufacturing Practice
Regulations for Finished
Pharmaceuticals—21 CFR Parts 210
and 211 (OMB Control Number 0910–
0139)—Extension
Under section 501(a)(2)(B) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 351(a)(2)(B)),
a drug is adulterated if the methods
used in, or the facilities or controls used
for, its manufacture, processing,
packing, or holding do not conform to
or are not operated or administered in
conformity with CGMPs to ensure that
such drug meets the requirements of the
FD&C Act as to safety, and has the
identity and strength, and meets the
quality and purity characteristics, which
it purports or is represented to possess.
The FDA has the authority under
section 701(a) of the FD&C Act (21
U.S.C. 371(a)) to issue regulations for
the efficient enforcement of the FD&C
Act regarding CGMP procedures for
manufacturing, processing, and holding
drugs and drug products. The CGMP
regulations help ensure that drug
products meet the statutory
requirements for safety and have their
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purported or represented identity,
strength, quality, and purity
characteristics. The information
collection requirements in the CGMP
regulations provide FDA with the
necessary information to perform its
duty to protect public health and safety.
CGMP requirements establish
accountability in the manufacturing and
processing of drug products, provide for
meaningful FDA inspections, and
enable manufacturers to improve the
quality of drug products over time. The
CGMP recordkeeping requirements also
serve preventive and remedial purposes
and provide crucial information if it is
necessary to recall a drug product.
The general requirements for
recordkeeping under part 211 (21 CFR
part 211) are set forth in § 211.180. Any
production, control, or distribution
record associated with a batch and
required to be maintained in
compliance with part 211 must be
retained for at least 1 year after the
expiration date of the batch and, for
certain over-the-counter (OTC) drugs, 3
years after distribution of the batch
(§ 211.180(a)). Records for all
components, drug product containers,
closures, and labeling are required to be
maintained for at least 1 year after the
expiration date and 3 years for certain
OTC products (§ 211.180(b)).
All part 211 records must be readily
available for authorized inspections
during the retention period
(§ 211.180(c)), and such records may be
retained either as original records or as
true copies (§ 211.180(d)). In addition,
21 CFR 11.2(a) provides that ‘‘for
records required to be maintained but
not submitted to the Agency, persons
may use electronic records in lieu of
paper records or electronic signatures in
lieu of traditional signatures, in whole
or in part, provided that the
requirements of this part are met.’’ To
the extent this electronic option is used,
the burden of maintaining paper records
should be substantially reduced, as
should any review of such records.
In order to facilitate improvements
and corrective actions, records must be
maintained so that data can be used for
evaluating, at least annually, the quality
standards of each drug product to
determine the need for changes in drug
product specifications or manufacturing
or control procedures (§ 211.180(e)).
Written procedures for these evaluations
are to be established and include
provisions for a review of a
representative number of batches and,
where applicable, records associated
with the batch; provisions for a review
of complaints, recalls, returned, or
salvaged drug products; and
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Frm 00043
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investigations conducted under
§ 211.192 for each drug product.
The specific recordkeeping
requirements provided in table 1 are as
follows:
Section 211.34—Consultants advising
on the manufacture, processing,
packing, or holding of drug products
must have sufficient education, training,
and experience to advise on the subject
for which they are retained. Records
must be maintained stating the name,
address, and qualifications of any
consultants and the type of service they
provide.
Section 211.67(c)—Records must be
kept of maintenance, cleaning,
sanitizing, and inspection as specified
in §§ 211.180 and 211.182.
Section 211.68—Appropriate controls
must be exercised over computer or
related systems to assure that changes in
master production and control records
or other records are instituted only by
authorized personnel.
Section 211.68(a)—Records must be
maintained of calibration checks,
inspections, and computer or related
system programs for automatic,
mechanical, and electronic equipment.
Section 211.68(b)—All appropriate
controls must be exercised over all
computers or related systems and
control data systems to assure that
changes in master production and
control records or other records are
instituted only by authorized persons.
Section 211.72—Filters for liquid
filtration used in the manufacture,
processing, or packing of injectable drug
products intended for human use must
not release fibers into such products.
Section 211.80(d)—Each container or
grouping of containers for components
or drug product containers or closures
must be identified with a distinctive
code for each lot in each shipment
received. This code must be used in
recording the disposition of each lot.
Each lot must be appropriately
identified as to its status.
Section 211.100(b)—Written
production and process control
procedures must be followed in the
execution of the various production and
process control functions and must be
documented at the time of performance.
Any deviation from the written
procedures must be recorded and
justified.
Section 211.105(b)—Major equipment
must be identified by a distinctive
identification number or code that must
be recorded in the batch production
record to show the specific equipment
used in the manufacture of each batch
of a drug product. In cases where only
one of a particular type of equipment
exists in a manufacturing facility, the
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Federal Register / Vol. 79, No. 217 / Monday, November 10, 2014 / Notices
name of the equipment may be used in
lieu of a distinctive identification
number or code.
Section 211.122(c)—Records must be
maintained for each shipment received
of each different labeling and packaging
material indicating receipt,
examination, or testing.
Section 211.130(e)—Inspection of
packaging and labeling facilities must be
made immediately before use to assure
that all drug products have been
removed from previous operations.
Inspection must also be made to assure
that packaging and labeling materials
not suitable for subsequent operations
have been removed. Results of
inspection must be documented in the
batch production records.
Section 211.132(c)—Certain retail
packages of OTC drug products must
bear a statement that is prominently
placed so consumers are alerted to the
specific tamper-evident feature of the
package. The labeling statement is
required to be so placed that it will be
unaffected if the tamper-resistant feature
of the package is breached or missing.
If the tamper-evident feature chosen is
one that uses an identifying
characteristic, that characteristic is
required to be referred to in the labeling
statement.
Section 211.132(d)—A request for an
exemption from packaging and labeling
requirements by a manufacturer or
packer is required to be submitted in the
form of a citizen petition under 21 CFR
10.30.
Section 211.137—Requirements
regarding product expiration dating and
compliance with 21 CFR 201.17.
Section 211.160(a)—The
establishment of any specifications,
standards, sampling plans, test
procedures, or other laboratory control
mechanisms, including any change in
such specifications, standards, sampling
plans, test procedures, or other
laboratory control mechanisms, must be
drafted by the appropriate
organizational unit and reviewed and
approved by the quality control unit.
These requirements must be followed
and documented at the time of
performance. Any deviation from the
written specifications, standards,
sampling plans, test procedures, or
other laboratory control mechanisms
must be recorded and justified.
Section 211.165(e)—The accuracy,
sensitivity, specificity, and
reproducibility of test methods
employed by a firm must be established
and documented. Such validation and
documentation may be accomplished in
accordance with § 211.194(a)(2).
Section 211.166—Stability testing
program for drug products.
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Section 211.173—Animals used in
testing components, in-process
materials, or drug products for
compliance with established
specifications must be maintained and
controlled in a manner that assures their
suitability for their intended use. They
must be identified, and adequate
records must be maintained showing the
history of their use.
Section 211.180(e)—Written records
required by part 211 must be
maintained so that data can be used for
evaluating, at least annually, the quality
standards of each drug product to
determine the need for changes in drug
product specifications or manufacturing
or control procedures. Written
procedures must be established and
followed for such evaluations and must
include provisions for a representative
number of batches, whether approved or
unapproved or rejected, and a review of
complaints, recalls, returned, or
salvaged drug products, and
investigations conducted under
§ 211.192 for each drug product.
Section 211.180(f)—Procedures must
be established to assure that the
responsible officials of the firm, if they
are not personally involved in or
immediately aware of such actions, are
notified in writing of any investigations,
conducted under § 211.198, 211.204, or
211.208, any recalls, reports of
inspectional observations issued, or any
regulatory actions relating to good
manufacturing practices brought by
FDA.
Section 211.182—Specifies
requirements for equipment cleaning
records and the use log.
Section 211.184—Specifies
requirements for component, drug
product container, closure, and labeling
records.
Section 211.186—Specifies master
production and control records
requirements.
Section 211.188—Specifies batch
production and control records
requirement.
Section 211.192—Specifies the
information that must be maintained on
the investigation of discrepancies found
in the review of all drug product
production and control records by the
quality control staff.
Section 211.194—Explains and
describes laboratory records that must
be retained.
Section 211.196—Specifies the
information that must be included in
records on the distribution of the drug.
Section 211.198—Specifies and
describes the handling of all complaint
files received by the applicant.
Section 211.204—Specifies that
records be maintained of returned and
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Frm 00044
Fmt 4703
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salvaged drug products and describes
the procedures involved.
Written procedures, referred to here
as standard operating procedures
(SOPs), are required for many part 211
records. The current SOP requirements
were initially provided in a final rule
published in the Federal Register of
September 29, 1978 (43 FR 45014), and
are now an integral and familiar part of
the drug manufacturing process. The
major information collection impact of
SOPs results from their creation.
Thereafter, SOPs need to be periodically
updated. A combined estimate for
routine maintenance of SOPs is
provided in table 1. The 25 SOP
provisions under part 211 in the
combined maintenance estimate
include:
Section 211.22(d)—Responsibilities
and procedures of the quality control
unit;
Section 211.56(b)—Sanitation
procedures;
Section 211.56(c)—Use of suitable
rodenticides, insecticides, fungicides,
fumigating agents, and cleaning and
sanitizing agents;
Section 211.67(b)—Cleaning and
maintenance of equipment;
Section 211.68(a)—Proper
performance of automatic, mechanical,
and electronic equipment;
Section 211.80(a)—Receipt,
identification, storage, handling,
sampling, testing, and approval or
rejection of components and drug
product containers or closures;
Section 211.94(d)—Standards or
specifications, methods of testing, and
methods of cleaning, sterilizing, and
processing to remove pyrogenic
properties for drug product containers
and closures;
Section 211.100(a)—Production and
process control;
Section 211.110(a)—Sampling and
testing of in-process materials and drug
products;
Section 211.113(a)—Prevention of
objectionable microorganisms in drug
products not required to be sterile;
Section 211.113(b)—Prevention of
microbiological contamination of drug
products purporting to be sterile,
including validation of any sterilization
process;
Section 211.115(a)—System for
reprocessing batches that do not
conform to standards or specifications,
to insure that reprocessed batches
conform with all established standards,
specifications, and characteristics;
Section 211.122(a)—Receipt,
identification, storage, handling,
sampling, examination and/or testing of
labeling and packaging materials;
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Section 211.125(f)—Control
procedures for the issuance of labeling;
Section 211.130—Packaging and label
operations, prevention of mixup and
cross contamination, identification and
handling of filed drug product
containers that are set aside and held in
unlabeled condition, and identification
of the drug product with a lot or control
number that permits determination of
the history of the manufacture and
control of the batch;
Section 211.142—Warehousing;
Section 211.150—Distribution of drug
products;
Section 211.160—Laboratory controls;
Section 211.165(c)—Testing and
release for distribution;
Section 211.166(a)—Stability testing;
Section 211.167—Special testing
requirements;
Section 211.180(f)—Notification of
responsible officials of investigations,
recalls, reports of inspectional
observations, and any regulatory actions
relating to good manufacturing practice;
Section 211.198(a)—Written and oral
complaint procedures, including quality
control unit review of any complaint
involving specifications failures, and
serious and unexpected adverse drug
experiences;
Section 211.204—Holding, testing,
and reprocessing of returned drug
products; and
Section 211.208—Drug product
salvaging.
In addition, the following regulations
in parts 610 and 680 (21 CFR parts 610
and 680) reference certain CGMP
regulations in part 211: §§ 610.12(g),
610.13(a)(2), 610.18(d), 680.2(f), and
66727
680.3(f). In table 1, the burden
associated with the information
collection requirements in these
regulations is included in the burden
estimates under §§ 211.165, 211.167,
211.188, and 211.194, as appropriate.
Although most of the CGMP
provisions covered in this document
were created many years ago, there will
be some existing firms expanding into
new manufacturing areas and startup
firms that will need to create SOPs. As
provided in table 1, FDA is assuming
that approximately 100 firms will have
to create up to 25 SOPs for a total of
2,500 records, and the Agency estimates
that it will take 20 hours per
recordkeeper to create 25 new SOPs for
a total of 50,000 hours.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
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SOP Maintenance .....................................................
New startup SOPs .....................................................
211.34—Consultants .................................................
211.67(c)—Equipment cleaning and maintenance ...
211.68—Changes in master production and control
records or other records.
211.68(a)—Automatic, mechanical, and electronic
equipment.
211.68(b)—Computer or related systems .................
211.72—Filters ..........................................................
211.80(d)—Components and drug product containers or closures.
211.100(b)—Production and process controls ..........
211.105(b)—Equipment identification .......................
211.122(c)—Labeling and packaging material ..........
211.130(e)—Labeling and packaging facilities .........
211.132(c)—Tamper-evident packaging ...................
211.132(d)—Tamper-evident packaging ...................
211.137—Expiration dating .......................................
211.160(a)—Laboratory controls ...............................
211.165(e)—Test methodology .................................
211.166—Stability testing ..........................................
211.173—Laboratory animals ...................................
211.180(e)—Production, control, and distribution
records.
211.180(f)—Procedures for notification of regulatory
actions.
211.182—Equipment cleaning and use log ..............
211.184—Component, drug product container, closure, and labeling records.
211.186—Master production and control records .....
211.188—Batch production and control records .......
211.192—Discrepancies in drug product production
and control records.
211.194—Laboratory records ....................................
211.196—Distribution records ...................................
211.198—Compliant files ..........................................
211.204—Returned drug products ............................
Total ....................................................................
1 There
Number of
records per
recordkeeper
Number of
recordkeepers
21 CFR Section
4,360
100
4,360
4,360
4,360
1
25
Total
annual
records
Average
burden per
recordkeeping
50
2
4,360
2500
1,090
218,000
8,720
25 ...........................
20 ...........................
0.50 (30 minutes) ..
.25 (15 minutes) .....
1 .............................
109,000
50,000
545
54,500
8,720
4,360
10
43,600
.50 (30 minutes) .....
21,800
4,360
4,360
4,360
5
21,800
1,090
1,090
.25 (15 minutes) .....
1 .............................
.10 (6 minutes) ......
5,450
1,090
109
4,360
4,360
4,360
4,360
1,769
1,769
4,360
4,360
4,360
4,360
1,077
4,360
3
50
50
20
.2
5
2
1
2
1
.2
13,080
1,090
218,000
218,000
35,380
354
21,800
8,720
4,360
8,720
1,077
872
2 .............................
.25 (15 minutes) .....
.25 (15 minutes) .....
.25 (15 minutes) .....
.50 (30 minutes) .....
.50 (30 minutes) .....
.50 (30 minutes) .....
1 .............................
1 .............................
.50 (30 minutes) .....
.25 (15 minutes) .....
.25 (15 minutes) .....
26,160
273
54,500
54,500
17,690
177
10,900
8,720
4,360
4,360
269
218
4,360
.2
872
1 .............................
872
.25
.25
.25
.25
4,360
4,360
2
3
8,720
13,080
.25 (15 minutes) .....
.50 (30 minutes) .....
2,180
6,540
4,360
4,360
4,360
10
25
2
43,600
109,000
8,720
2 .............................
2 .............................
1 .............................
87,200
218,000
8,720
4,360
4,360
4,360
4,360
25
25
5
10
109,000
109,000
21,800
43,600
.50 (30 minutes) .....
.25 (15 minutes) .....
1 .............................
.50 (30 minutes) .....
54,500
27,250
21,800
21,800
........................
................................
882,203
........................
..........................
are no capital costs or operating and maintenance costs associated with this collection of information.
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Total hours
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Dated: November 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–26596 Filed 11–7–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1106]
Armando Santos: Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) debarring
Armando Santos from providing
services in any capacity to a person that
has an approved or pending drug
product application for a period of 12
years. FDA bases this order on a finding
that Mr. Santos was convicted of seven
felony counts under Federal law for
conduct involving health care fraud,
conspiracy to commit health care fraud,
and false statements related to health
care matters and that this pattern of
conduct is sufficient to find that there
is reason to believe he may violate
requirements under the FD&C Act
relating to drug products. Mr. Santos
was given notice of the proposed
debarment and an opportunity to
request a hearing within the timeframe
prescribed by regulation. Mr. Santos
failed to respond. Mr. Santos’s failure to
respond constitutes a waiver of his right
to a hearing concerning this action.
DATES: This order is effective November
10, 2014.
SUMMARY:
Submit applications for
termination of debarment to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Kenny Shade, Division of Enforcement,
Office of Enforcement and Import
Operations, Office of Regulatory Affairs,
Food and Drug Administration, 12420
Parklawn Dr., Element Bldg., Rm. 4144,
Rockville, MD 20857, 301–796–4640.
SUPPLEMENTARY INFORMATION:
asabaliauskas on DSK5VPTVN1PROD with NOTICES
ADDRESSES:
I. Background
Section 306(b)(2)(B)(ii)(I) of the FD&C
Act (21 U.S.C. 335a(b)(2)(B)(ii)(I))
permits debarment of an individual if
FDA finds that the individual has been
convicted of a felony under Federal law
VerDate Sep<11>2014
18:25 Nov 07, 2014
Jkt 235001
for conduct that involves bribery,
payment of illegal gratuities, fraud,
perjury, false statement, racketeering,
blackmail, extortion, falsification or
destruction of records, or interference
with, obstruction of an investigation
into, or prosecution of any criminal
offense, and it finds, on the basis of the
conviction and other information, that
such individual has demonstrated a
pattern of conduct sufficient to find that
there is reason to believe the individual
may violate requirements under the
FD&C Act relating to drug products.
On August 15, 2011, the U.S. District
Court for the Southern District of
Florida entered judgment against Mr.
Santos after a jury found him guilty of
four counts of health care fraud in
violation of 18 U.S.C. 1347, one count
of conspiracy to commit health care
fraud in violation of 18 U.S.C. 1349, and
two counts of false statements related to
health care matters in violation of 18
U.S.C. 1035(a)(2).
The FDA’s finding that debarment is
appropriate is based on the felony
convictions referenced herein. The
factual basis for these convictions is as
follows: Mr. Santos was a registered
nurse working for a home health agency
located in the Southern District of
Florida. As a registered nurse in the
home health field, it was Mr. Santos’s
duty to provide skilled nursing services
to patients and maintain proper
documentation of all treatments
provided to patients.
From on or about June 29, 2007,
through on or about March 13, 2009, Mr.
Santos conspired with others to defraud
Medicare. Mr. Santos and his
coconspirators, among other things,
submitted and caused the submission of
false and fraudulent claims to Medicare,
and paid kickbacks and bribes to
Medicare beneficiaries in exchange for
the use of their Medicare beneficiary
numbers as the bases of claims filed for
home health care. Mr. Santos and his
co-conspirators signed patient
assessment forms falsely certifying that
Medicare beneficiaries were in need of
home health services that were
medically unnecessary.
Mr. Santos created false weekly visit/
time records in which he claimed to be
providing skilled nursing services to
two separate Medicare beneficiaries at
the same time. On four separate
occasions, Mr. Santos submitted and
caused the submission of false and
fraudulent claims to Medicare,
representing that he had provided
various home health services to
beneficiaries pursuant to physicians’
plans of care. He caused a home health
agency to submit approximately
$230,315 in false and fraudulent claims
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
to Medicare for home health services
allegedly rendered to Medicare
beneficiaries, when such home health
services were not medically necessary
and had not been provided. As a result
of these fraudulent claims, Mr. Santos
caused Medicare to make payments of
approximately $152,664 to a MiamiDade County home health agency.
In addition, Mr. Santos knowingly
and willfully made materially false
statements and representations, in
connection with the delivery of and
payment for health care benefits, items,
and services. Specifically, Mr. Santos
prepared documents entitled ‘‘Skilled
Nursing Progress Note[s]’’ which falsely
stated that he had injected Medicare
beneficiaries with insulin on two
occasions, when he knew he had not
performed these services.
As a result of his convictions, on
April 9, 2014, FDA sent Mr. Santos a
notice by certified mail proposing to
debar him for 12 years from providing
services in any capacity to a person that
has an approved or pending drug
product application. The proposal was
based on the finding, under section
306(b)(2)(B)(ii)(I) of the FD&C Act, that
Mr. Santos was convicted of seven
felonies under Federal law for conduct
involving health care fraud, conspiracy
to commit health care fraud, and false
statements related to health care
matters, and that the Agency found, on
the basis of these convictions and other
information, that Mr. Santos had
demonstrated a pattern of conduct
sufficient to find that there is reason to
believe he may violate requirements
under the FD&C Act relating to drug
products. This conclusion was based on
the fact that Mr. Santos had legal and
professional obligations to ensure that
he kept accurate medical records for
each patient and that he submitted
accurate medical claims for services he
provided. Instead, Mr. Santos signed
patient assessment forms falsely
certifying that Medicare beneficiaries
were in need of home health services
that were medically unnecessary, and
he submitted false weekly visit/time
records. Mr. Santos additionally
prepared false ‘‘Skilled Nursing Progress
Note[s]’’ stating that he had injected two
Medicare beneficiaries with insulin
when he had not done so. He submitted
and caused the submission of false and
fraudulent claims to Medicare. He
engaged in this conduct repeatedly over
a period of almost 2 years. His
convictions indicate that he knowingly
and willfully disregarded his legal and
professional obligations to keep accurate
medical records and to submit accurate
claims for the services he provided.
E:\FR\FM\10NON1.SGM
10NON1
]]>Agencies
[Federal Register Volume 79, Number 217 (Monday, November 10, 2014)]
[Notices]
[Pages 66724-66728]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-26596]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0362]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Current Good Manufacturing Practice Regulations for
Finished Pharmaceuticals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the current good manufacturing
practice (CGMP) regulations for finished pharmaceuticals.
DATES: Submit either electronic or written comments on the collection
of information by January 9, 2015.
ADDRESSES: Submit electronic comments on the collection of information
to: https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the 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, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of
[[Page 66725]]
information they conduct or sponsor. ``Collection of information'' is
defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency
requests or requirements that members of the public submit reports,
keep records, or provide information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in the Federal Register concerning
each proposed collection of information, including each proposed
extension of an existing collection of information, before submitting
the collection to OMB for approval. To comply with this requirement,
FDA is publishing notice of the proposed collection of information set
forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Current Good Manufacturing Practice Regulations for Finished
Pharmaceuticals--21 CFR Parts 210 and 211 (OMB Control Number 0910-
0139)--Extension
Under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 351(a)(2)(B)), a drug is adulterated if
the methods used in, or the facilities or controls used for, its
manufacture, processing, packing, or holding do not conform to or are
not operated or administered in conformity with CGMPs to ensure that
such drug meets the requirements of the FD&C Act as to safety, and has
the identity and strength, and meets the quality and purity
characteristics, which it purports or is represented to possess.
The FDA has the authority under section 701(a) of the FD&C Act (21
U.S.C. 371(a)) to issue regulations for the efficient enforcement of
the FD&C Act regarding CGMP procedures for manufacturing, processing,
and holding drugs and drug products. The CGMP regulations help ensure
that drug products meet the statutory requirements for safety and have
their purported or represented identity, strength, quality, and purity
characteristics. The information collection requirements in the CGMP
regulations provide FDA with the necessary information to perform its
duty to protect public health and safety. CGMP requirements establish
accountability in the manufacturing and processing of drug products,
provide for meaningful FDA inspections, and enable manufacturers to
improve the quality of drug products over time. The CGMP recordkeeping
requirements also serve preventive and remedial purposes and provide
crucial information if it is necessary to recall a drug product.
The general requirements for recordkeeping under part 211 (21 CFR
part 211) are set forth in Sec. 211.180. Any production, control, or
distribution record associated with a batch and required to be
maintained in compliance with part 211 must be retained for at least 1
year after the expiration date of the batch and, for certain over-the-
counter (OTC) drugs, 3 years after distribution of the batch (Sec.
211.180(a)). Records for all components, drug product containers,
closures, and labeling are required to be maintained for at least 1
year after the expiration date and 3 years for certain OTC products
(Sec. 211.180(b)).
All part 211 records must be readily available for authorized
inspections during the retention period (Sec. 211.180(c)), and such
records may be retained either as original records or as true copies
(Sec. 211.180(d)). In addition, 21 CFR 11.2(a) provides that ``for
records required to be maintained but not submitted to the Agency,
persons may use electronic records in lieu of paper records or
electronic signatures in lieu of traditional signatures, in whole or in
part, provided that the requirements of this part are met.'' To the
extent this electronic option is used, the burden of maintaining paper
records should be substantially reduced, as should any review of such
records.
In order to facilitate improvements and corrective actions, records
must be maintained so that data can be used for evaluating, at least
annually, the quality standards of each drug product to determine the
need for changes in drug product specifications or manufacturing or
control procedures (Sec. 211.180(e)). Written procedures for these
evaluations are to be established and include provisions for a review
of a representative number of batches and, where applicable, records
associated with the batch; provisions for a review of complaints,
recalls, returned, or salvaged drug products; and investigations
conducted under Sec. 211.192 for each drug product.
The specific recordkeeping requirements provided in table 1 are as
follows:
Section 211.34--Consultants advising on the manufacture,
processing, packing, or holding of drug products must have sufficient
education, training, and experience to advise on the subject for which
they are retained. Records must be maintained stating the name,
address, and qualifications of any consultants and the type of service
they provide.
Section 211.67(c)--Records must be kept of maintenance, cleaning,
sanitizing, and inspection as specified in Sec. Sec. 211.180 and
211.182.
Section 211.68--Appropriate controls must be exercised over
computer or related systems to assure that changes in master production
and control records or other records are instituted only by authorized
personnel.
Section 211.68(a)--Records must be maintained of calibration
checks, inspections, and computer or related system programs for
automatic, mechanical, and electronic equipment.
Section 211.68(b)--All appropriate controls must be exercised over
all computers or related systems and control data systems to assure
that changes in master production and control records or other records
are instituted only by authorized persons.
Section 211.72--Filters for liquid filtration used in the
manufacture, processing, or packing of injectable drug products
intended for human use must not release fibers into such products.
Section 211.80(d)--Each container or grouping of containers for
components or drug product containers or closures must be identified
with a distinctive code for each lot in each shipment received. This
code must be used in recording the disposition of each lot. Each lot
must be appropriately identified as to its status.
Section 211.100(b)--Written production and process control
procedures must be followed in the execution of the various production
and process control functions and must be documented at the time of
performance. Any deviation from the written procedures must be recorded
and justified.
Section 211.105(b)--Major equipment must be identified by a
distinctive identification number or code that must be recorded in the
batch production record to show the specific equipment used in the
manufacture of each batch of a drug product. In cases where only one of
a particular type of equipment exists in a manufacturing facility, the
[[Page 66726]]
name of the equipment may be used in lieu of a distinctive
identification number or code.
Section 211.122(c)--Records must be maintained for each shipment
received of each different labeling and packaging material indicating
receipt, examination, or testing.
Section 211.130(e)--Inspection of packaging and labeling facilities
must be made immediately before use to assure that all drug products
have been removed from previous operations. Inspection must also be
made to assure that packaging and labeling materials not suitable for
subsequent operations have been removed. Results of inspection must be
documented in the batch production records.
Section 211.132(c)--Certain retail packages of OTC drug products
must bear a statement that is prominently placed so consumers are
alerted to the specific tamper-evident feature of the package. The
labeling statement is required to be so placed that it will be
unaffected if the tamper-resistant feature of the package is breached
or missing. If the tamper-evident feature chosen is one that uses an
identifying characteristic, that characteristic is required to be
referred to in the labeling statement.
Section 211.132(d)--A request for an exemption from packaging and
labeling requirements by a manufacturer or packer is required to be
submitted in the form of a citizen petition under 21 CFR 10.30.
Section 211.137--Requirements regarding product expiration dating
and compliance with 21 CFR 201.17.
Section 211.160(a)--The establishment of any specifications,
standards, sampling plans, test procedures, or other laboratory control
mechanisms, including any change in such specifications, standards,
sampling plans, test procedures, or other laboratory control
mechanisms, must be drafted by the appropriate organizational unit and
reviewed and approved by the quality control unit. These requirements
must be followed and documented at the time of performance. Any
deviation from the written specifications, standards, sampling plans,
test procedures, or other laboratory control mechanisms must be
recorded and justified.
Section 211.165(e)--The accuracy, sensitivity, specificity, and
reproducibility of test methods employed by a firm must be established
and documented. Such validation and documentation may be accomplished
in accordance with Sec. 211.194(a)(2).
Section 211.166--Stability testing program for drug products.
Section 211.173--Animals used in testing components, in-process
materials, or drug products for compliance with established
specifications must be maintained and controlled in a manner that
assures their suitability for their intended use. They must be
identified, and adequate records must be maintained showing the history
of their use.
Section 211.180(e)--Written records required by part 211 must be
maintained so that data can be used for evaluating, at least annually,
the quality standards of each drug product to determine the need for
changes in drug product specifications or manufacturing or control
procedures. Written procedures must be established and followed for
such evaluations and must include provisions for a representative
number of batches, whether approved or unapproved or rejected, and a
review of complaints, recalls, returned, or salvaged drug products, and
investigations conducted under Sec. 211.192 for each drug product.
Section 211.180(f)--Procedures must be established to assure that
the responsible officials of the firm, if they are not personally
involved in or immediately aware of such actions, are notified in
writing of any investigations, conducted under Sec. 211.198, 211.204,
or 211.208, any recalls, reports of inspectional observations issued,
or any regulatory actions relating to good manufacturing practices
brought by FDA.
Section 211.182--Specifies requirements for equipment cleaning
records and the use log.
Section 211.184--Specifies requirements for component, drug product
container, closure, and labeling records.
Section 211.186--Specifies master production and control records
requirements.
Section 211.188--Specifies batch production and control records
requirement.
Section 211.192--Specifies the information that must be maintained
on the investigation of discrepancies found in the review of all drug
product production and control records by the quality control staff.
Section 211.194--Explains and describes laboratory records that
must be retained.
Section 211.196--Specifies the information that must be included in
records on the distribution of the drug.
Section 211.198--Specifies and describes the handling of all
complaint files received by the applicant.
Section 211.204--Specifies that records be maintained of returned
and salvaged drug products and describes the procedures involved.
Written procedures, referred to here as standard operating
procedures (SOPs), are required for many part 211 records. The current
SOP requirements were initially provided in a final rule published in
the Federal Register of September 29, 1978 (43 FR 45014), and are now
an integral and familiar part of the drug manufacturing process. The
major information collection impact of SOPs results from their
creation. Thereafter, SOPs need to be periodically updated. A combined
estimate for routine maintenance of SOPs is provided in table 1. The 25
SOP provisions under part 211 in the combined maintenance estimate
include:
Section 211.22(d)--Responsibilities and procedures of the quality
control unit;
Section 211.56(b)--Sanitation procedures;
Section 211.56(c)--Use of suitable rodenticides, insecticides,
fungicides, fumigating agents, and cleaning and sanitizing agents;
Section 211.67(b)--Cleaning and maintenance of equipment;
Section 211.68(a)--Proper performance of automatic, mechanical, and
electronic equipment;
Section 211.80(a)--Receipt, identification, storage, handling,
sampling, testing, and approval or rejection of components and drug
product containers or closures;
Section 211.94(d)--Standards or specifications, methods of testing,
and methods of cleaning, sterilizing, and processing to remove
pyrogenic properties for drug product containers and closures;
Section 211.100(a)--Production and process control;
Section 211.110(a)--Sampling and testing of in-process materials
and drug products;
Section 211.113(a)--Prevention of objectionable microorganisms in
drug products not required to be sterile;
Section 211.113(b)--Prevention of microbiological contamination of
drug products purporting to be sterile, including validation of any
sterilization process;
Section 211.115(a)--System for reprocessing batches that do not
conform to standards or specifications, to insure that reprocessed
batches conform with all established standards, specifications, and
characteristics;
Section 211.122(a)--Receipt, identification, storage, handling,
sampling, examination and/or testing of labeling and packaging
materials;
[[Page 66727]]
Section 211.125(f)--Control procedures for the issuance of
labeling;
Section 211.130--Packaging and label operations, prevention of
mixup and cross contamination, identification and handling of filed
drug product containers that are set aside and held in unlabeled
condition, and identification of the drug product with a lot or control
number that permits determination of the history of the manufacture and
control of the batch;
Section 211.142--Warehousing;
Section 211.150--Distribution of drug products;
Section 211.160--Laboratory controls;
Section 211.165(c)--Testing and release for distribution;
Section 211.166(a)--Stability testing;
Section 211.167--Special testing requirements;
Section 211.180(f)--Notification of responsible officials of
investigations, recalls, reports of inspectional observations, and any
regulatory actions relating to good manufacturing practice;
Section 211.198(a)--Written and oral complaint procedures,
including quality control unit review of any complaint involving
specifications failures, and serious and unexpected adverse drug
experiences;
Section 211.204--Holding, testing, and reprocessing of returned
drug products; and
Section 211.208--Drug product salvaging.
In addition, the following regulations in parts 610 and 680 (21 CFR
parts 610 and 680) reference certain CGMP regulations in part 211:
Sec. Sec. 610.12(g), 610.13(a)(2), 610.18(d), 680.2(f), and 680.3(f).
In table 1, the burden associated with the information collection
requirements in these regulations is included in the burden estimates
under Sec. Sec. 211.165, 211.167, 211.188, and 211.194, as
appropriate.
Although most of the CGMP provisions covered in this document were
created many years ago, there will be some existing firms expanding
into new manufacturing areas and startup firms that will need to create
SOPs. As provided in table 1, FDA is assuming that approximately 100
firms will have to create up to 25 SOPs for a total of 2,500 records,
and the Agency estimates that it will take 20 hours per recordkeeper to
create 25 new SOPs for a total of 50,000 hours.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
SOP Maintenance.............................. 4,360 1 4,360 25....................................... 109,000
New startup SOPs............................. 100 25 2500 20....................................... 50,000
211.34--Consultants.......................... 4,360 .25 1,090 0.50 (30 minutes)........................ 545
211.67(c)--Equipment cleaning and maintenance 4,360 50 218,000 .25 (15 minutes)......................... 54,500
211.68--Changes in master production and 4,360 2 8,720 1........................................ 8,720
control records or other records.
211.68(a)--Automatic, mechanical, and 4,360 10 43,600 .50 (30 minutes)......................... 21,800
electronic equipment.
211.68(b)--Computer or related systems....... 4,360 5 21,800 .25 (15 minutes)......................... 5,450
211.72--Filters.............................. 4,360 .25 1,090 1........................................ 1,090
211.80(d)--Components and drug product 4,360 .25 1,090 .10 (6 minutes).......................... 109
containers or closures.
211.100(b)--Production and process controls.. 4,360 3 13,080 2........................................ 26,160
211.105(b)--Equipment identification......... 4,360 .25 1,090 .25 (15 minutes)......................... 273
211.122(c)--Labeling and packaging material.. 4,360 50 218,000 .25 (15 minutes)......................... 54,500
211.130(e)--Labeling and packaging facilities 4,360 50 218,000 .25 (15 minutes)......................... 54,500
211.132(c)--Tamper-evident packaging......... 1,769 20 35,380 .50 (30 minutes)......................... 17,690
211.132(d)--Tamper-evident packaging......... 1,769 .2 354 .50 (30 minutes)......................... 177
211.137--Expiration dating................... 4,360 5 21,800 .50 (30 minutes)......................... 10,900
211.160(a)--Laboratory controls.............. 4,360 2 8,720 1........................................ 8,720
211.165(e)--Test methodology................. 4,360 1 4,360 1........................................ 4,360
211.166--Stability testing................... 4,360 2 8,720 .50 (30 minutes)......................... 4,360
211.173--Laboratory animals.................. 1,077 1 1,077 .25 (15 minutes)......................... 269
211.180(e)--Production, control, and 4,360 .2 872 .25 (15 minutes)......................... 218
distribution records.
211.180(f)--Procedures for notification of 4,360 .2 872 1........................................ 872
regulatory actions.
211.182--Equipment cleaning and use log...... 4,360 2 8,720 .25 (15 minutes)......................... 2,180
211.184--Component, drug product container, 4,360 3 13,080 .50 (30 minutes)......................... 6,540
closure, and labeling records.
211.186--Master production and control 4,360 10 43,600 2........................................ 87,200
records.
211.188--Batch production and control records 4,360 25 109,000 2........................................ 218,000
211.192--Discrepancies in drug product 4,360 2 8,720 1........................................ 8,720
production and control records.
211.194--Laboratory records.................. 4,360 25 109,000 .50 (30 minutes)......................... 54,500
211.196--Distribution records................ 4,360 25 109,000 .25 (15 minutes)......................... 27,250
211.198--Compliant files..................... 4,360 5 21,800 1........................................ 21,800
211.204--Returned drug products.............. 4,360 10 43,600 .50 (30 minutes)......................... 21,800
------------------------------------------------ ---------------
Total.................................... .............. .............. .............. ......................................... 882,203
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 66728]]
Dated: November 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-26596 Filed 11-7-14; 8:45 am]
BILLING CODE 4164-01-P
