82 FR 32834 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Type A Medicated Articles
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 136 (July 18, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 136 (July 18, 2017)
| Page Range | 32834-32835 | |
| FR Document | 2017-14996 |
[Federal Register Volume 82, Number 136 (Tuesday, July 18, 2017)] [Notices] [Pages 32834-32835] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-14996] ----------------------------------------------------------------------- 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: 202-395-7285, or emailed to [email protected]. 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. [[Page 32835]] 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, 301-796-7726, [email protected]. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. 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\ -------------------------------------------------------------------------------------------------------------------------------------------------------- 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 -------------------------------------------------------------------------------------------------------------------------------------------------------- \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
![32834 Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices
research before making important in each iteration in response to measures of their achievement in
decisions such as adopting new policies emerging and current events or issues. improving public health.
and allocating or redirecting significant In the next 3 years, we plan to field this Description of Respondents: The
resources to support these policies. survey two to three times. We will use respondents are adults, age 18 and
This survey has been repeated the information from the Health and
older, drawn from the 50 States and the
approximately every 3 to 5 years over Diet Survey to evaluate and develop
the course of the past 3 decades for the District of Columbia. Participation will
strategies and programs to encourage
purpose of tracking changes and trends and help consumers adopt healthy diets be voluntary.
in public opinions and consumer and lifestyles. The information will also FDA estimates the burden of this
behavior, with some new questions help FDA evaluate and track consumer collection of information as follows:
added or omitted or partially modified awareness and behavior as outcome
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response
Cognitive interview screener .................................... 100 1 100 0.08 (5 minutes) ........ 8
Cognitive interview ................................................... 18 1 18 1 ................................ 18
Pretest screener ....................................................... 2,000 1 2,000 0.033 (2 minutes) ...... 66
Pretest ...................................................................... 200 1 200 0.25 (15 minutes) ...... 50
Survey screener ....................................................... 40,000 1 40,000 0.033 (2 minutes) ...... 1,320
Survey ...................................................................... 4,000 1 4,000 0.25 (15 minutes) ...... 1,000
Total .................................................................. ........................ ........................ ........................ .................................... 2,462
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimate of the number respondent in each household reached DEPARTMENT OF HEALTH AND
of respondents and the average burden by landline telephone numbers to HUMAN SERVICES
per response on our experience with participate in the survey. A total of
previous Health and Diet Surveys and 40,000 individuals in the 50 states and Food and Drug Administration
we estimate that the burden for this the District of Columbia will be
information collection has increased by screened by telephone. We estimate that [Docket No. FDA–2010–N–0598]
580 hours (from 1,882 to 2,462 hours) it will take a respondent 2 minutes
since the last OMB approval. The (0.033 hours) to complete the screening, Agency Information Collection
increase is due to an expected increase for a total of 1,320 hours. We estimate Activities; Submission for Office of
in the number of participants Management and Budget Review;
that 4,000 eligible adults will participate
completing the survey screener (from Comment Request; Current Good
in the survey, each taking 15 minutes
30,000 to 40,000 participants) and Manufacturing Practice Regulations for
number of participants taking the survey (0.25 hours), for a total of 1,000 hours. Type A Medicated Articles
(from 3,000 to 4,000). We will use a Thus, the total estimated burden is
cognitive interview screener with 100 2,462 hours. AGENCY: Food and Drug Administration,
individuals to recruit prospective We are requesting this burden for HHS.
interview participants. We estimate that unplanned surveys so as not to restrict ACTION: Notice.
it will take a screener respondent our ability to gather information on
approximately 5 minutes (0.08 hours) to SUMMARY: The Food and Drug
consumer attitudes, awareness,
complete the cognitive interview Administration (FDA or we) is
knowledge, and behavior regarding announcing that a proposed collection
screener, for a total of 8 hours. We will various topics related to health,
conduct cognitive interviews with 18 of information has been submitted to the
nutrition, physical activity, and product Office of Management and Budget
participants. We estimate that it will labeling. This ability will help the
take a participant approximately 1 hour (OMB) for review and clearance under
Agency identify and respond to the Paperwork Reduction Act of 1995.
to complete the interview, for a total of emerging issues in a more timely
18 hours. Prior to the administration of DATES: Fax written comments on the
manner. collection of information by August 17,
the Health and Diet Survey, the Agency
plans to conduct a pretest to identify Dated: July 11, 2017. 2017.
and resolve potential survey Anna K. Abram, ADDRESSES: To ensure that comments on
administration problems. We will use a Deputy Commissioner for Policy, Planning, the information collection are received,
pretest screener with 2,000 individuals; Legislation, and Analysis. OMB recommends that written
we estimate that it will take a [FR Doc. 2017–15001 Filed 7–17–17; 8:45 am] comments be faxed to the Office of
respondent approximately 2 minutes BILLING CODE 4164–01–P
Information and Regulatory Affairs,
(0.033 hours) to complete the pretest OMB, Attn: FDA Desk Officer, FAX:
sradovich on DSK3GMQ082PROD with NOTICES
screener, for a total of 66 hours. The 202–395–7285, or emailed to oira_
pretest will be conducted with 200 submission@omb.eop.gov. All
participants; we estimate that it will comments should be identified with the
take a participant 15 minutes (0.25 OMB control number 0910–0154. Also
hours) to complete the pretest, for a total include the FDA docket number found
of 50 hours. We will use a survey in brackets in the heading of this
screener to select an eligible adult document.
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![Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices 32835
FOR FURTHER INFORMATION CONTACT: Ila treatment of disease or for growth working as planned. We review the
S. Mizrachi, Office of Operations, Food promotion and feed efficiency. records during the conduct of periodic
and Drug Administration, Three White Statutory requirements for cGMPs for plant inspections. This information is
Flint North, 10A63, 11601 Landsdown Type A medicated articles have been needed so that we can monitor drug
St., North Bethesda, MD 20852, 301– codified in part 226 (21 CFR part 226). usage and possible misformulation of
796–7726, PRAStaff@fda.hhs.gov. Type A medicated articles, which are Type A medicated articles. The
not manufactured in accordance with information could also prove useful to
SUPPLEMENTARY INFORMATION: In these regulations, are considered
compliance with 44 U.S.C. 3507, FDA us in investigating product defects when
adulterated under section 501(a)(2)(B) of a drug is recalled. In addition, we will
has submitted the following proposed the FD&C Act (21 U.S.C. 351(a)(2)(B)).
collection of information to OMB for use the cGMP criteria in part 226 to
Under part 226, a manufacturer is determine whether or not the systems
review and clearance. required to establish, maintain, and used by manufacturers of Type A
Current Good Manufacturing Practice retain records for Type A medicated medicated articles are adequate to
Regulations for Type A Medicated articles, including records to document assure that their medicated articles meet
Articles—21 CFR Part 226 OMB Control procedures required under the the requirements of the FD&C Act as to
Number 0910–0154—Extension manufacturing process to assure that safety and also meet the article’s
proper quality control is maintained. claimed identity, strength, quality, and
Under section 501 of the Federal Such records would, for example,
Food, Drug, and Cosmetic Act (the purity, as required by section
contain information concerning receipt 501(a)(2)(B) of the FD&C Act. The
FD&C Act), FDA has the statutory and inventory of drug components,
authority to issue current good respondents for Type A medicated
batch production, laboratory assay
manufacturing practice (cGMP) articles are pharmaceutical firms that
results (i.e., batch and stability testing),
regulations for drugs, including Type A manufacture both human and veterinary
and product distribution.
medicated articles. A Type A medicated The required records are used by both drugs, those firms that produce only
article is a feed product containing a the respondents and FDA. The records veterinary drugs, and commercial feed
concentrated drug diluted with a feed are used by manufacturers of Type A mills.
carrier substance. A Type A medicated medicated articles to verify that In the Federal Register of October 17,
article is intended solely for use in the appropriate control measures have been 2016 (81 FR 71513), FDA published a
manufacture of another Type A maintained, or that appropriate 60-day notice requesting public
medicated article or a Type B or Type corrective actions were taken if the comment on the proposed collection of
C medicated feed. Medicated feeds are control measures were not maintained. information. FDA received no comment.
administered to animals for the Such verification activities are essential FDA estimates the burden of this
prevention, cure, mitigation, or to ensure that the cGMP system is collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Noumber of
Number of Total annual Average burden per
21 CFR section records per Total hours
recordkeepers records recordkeeping
recordkeeper
226.42, requires records be prepared and main- 65 260 16,900 0.75 (45 minutes) ...... 12,675
tained for 2 years with respect to components
(drug and non-drug) used in the manufacture of
the medicated premixes.
226.58, requires recordkeeping for establishment 65 260 16,900 1.75 ........................... 29,575
of laboratory controls to ensure that adequate
specifications and test procedures for the drug
components and Type A medicated articles con-
form to appropriate standards of identity,
strength, quality, and purity.
226.80, requires maintenance of records for pack- 65 260 16,900 0.75 (45 minutes) ...... 12,675
aging and labeling of Type A medicated articles.
226.102, requires maintenance of master-formula 65 260 16,900 1.75 ........................... 29,575
and batch-production records for Type A medi-
cated articles.
226.110, requires maintenance of distribution 65 260 16,900 .25 (15 minutes) ........ 4,225
records (2 years) for each shipment of Type A
medicated articles for recall purposes.
226.115, requires maintenance of complaint files 65 10 650 .5 (30 minutes) .......... 325
for Type A medicated articles for 2 years.
Total .................................................................. ........................ ........................ ........................ .................................... 76, 375
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
sradovich on DSK3GMQ082PROD with NOTICES
We based our estimate of the time number of Type A medicated articles Dated: July 12, 2017.
required for record preparation and being manufactured, etc.) from our Anna K. Abram,
maintenance on our communications records and experience. The burden has Deputy Commissioner for Policy, Planning,
with industry. We derived additional not changed since the last OMB Legislation, and Analysis.
information needed to calculate the total approval. [FR Doc. 2017–14996 Filed 7–17–17; 8:45 am]
burden hours (i.e., manufacturing sites, BILLING CODE 4164–01–P
VerDate Sep<11>2014 17:47 Jul 17, 2017 Jkt 241001 PO 00000 Frm 00051 Fmt 4703 Sfmt 9990 E:\FR\FM\18JYN1.SGM 18JYN1](https://thefederalregister.org/doc/82_FR_32970/page/2.svg)
Document Created: 2018-10-24 11:24:46
Document Modified: 2018-10-24 11:24:46
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by August 17, 2017. | |
| Contact | Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected] | |
| FR Citation | 82 FR 32834 |
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