Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Type A Medicated Articles, 32834-32835 [2017-14996]

Download as PDF 32834 Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices research before making important decisions such as adopting new policies and allocating or redirecting significant resources to support these policies. This survey has been repeated approximately every 3 to 5 years over the course of the past 3 decades for the purpose of tracking changes and trends in public opinions and consumer behavior, with some new questions added or omitted or partially modified in each iteration in response to emerging and current events or issues. In the next 3 years, we plan to field this survey two to three times. We will use the information from the Health and Diet Survey to evaluate and develop strategies and programs to encourage and help consumers adopt healthy diets and lifestyles. The information will also help FDA evaluate and track consumer awareness and behavior as outcome measures of their achievement in improving public health. Description of Respondents: The respondents are adults, age 18 and older, drawn from the 50 States and the District of Columbia. Participation will be voluntary. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Activity Number of responses per respondent Average burden per response Total annual responses Total hours Cognitive interview screener .................................... Cognitive interview ................................................... Pretest screener ....................................................... Pretest ...................................................................... Survey screener ....................................................... Survey ...................................................................... 100 18 2,000 200 40,000 4,000 1 1 1 1 1 1 100 18 2,000 200 40,000 4,000 0.08 (5 minutes) ........ 1 ................................ 0.033 (2 minutes) ...... 0.25 (15 minutes) ...... 0.033 (2 minutes) ...... 0.25 (15 minutes) ...... 8 18 66 50 1,320 1,000 Total .................................................................. ........................ ........................ ........................ .................................... 2,462 sradovich on DSK3GMQ082PROD with NOTICES 1 There are no capital costs or operating and maintenance costs associated with this collection of information. We base our estimate of the number of respondents and the average burden per response on our experience with previous Health and Diet Surveys and we estimate that the burden for this information collection has increased by 580 hours (from 1,882 to 2,462 hours) since the last OMB approval. The increase is due to an expected increase in the number of participants completing the survey screener (from 30,000 to 40,000 participants) and number of participants taking the survey (from 3,000 to 4,000). We will use a cognitive interview screener with 100 individuals to recruit prospective interview participants. We estimate that it will take a screener respondent approximately 5 minutes (0.08 hours) to complete the cognitive interview screener, for a total of 8 hours. We will conduct cognitive interviews with 18 participants. We estimate that it will take a participant approximately 1 hour to complete the interview, for a total of 18 hours. Prior to the administration of the Health and Diet Survey, the Agency plans to conduct a pretest to identify and resolve potential survey administration problems. We will use a pretest screener with 2,000 individuals; we estimate that it will take a respondent approximately 2 minutes (0.033 hours) to complete the pretest screener, for a total of 66 hours. The pretest will be conducted with 200 participants; we estimate that it will take a participant 15 minutes (0.25 hours) to complete the pretest, for a total of 50 hours. We will use a survey screener to select an eligible adult VerDate Sep<11>2014 17:47 Jul 17, 2017 Jkt 241001 respondent in each household reached by landline telephone numbers to participate in the survey. A total of 40,000 individuals in the 50 states and the District of Columbia will be screened by telephone. We estimate that it will take a respondent 2 minutes (0.033 hours) to complete the screening, for a total of 1,320 hours. We estimate that 4,000 eligible adults will participate in the survey, each taking 15 minutes (0.25 hours), for a total of 1,000 hours. Thus, the total estimated burden is 2,462 hours. We are requesting this burden for unplanned surveys so as not to restrict our ability to gather information on consumer attitudes, awareness, knowledge, and behavior regarding various topics related to health, nutrition, physical activity, and product labeling. This ability will help the Agency identify and respond to emerging issues in a more timely manner. Dated: July 11, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–15001 Filed 7–17–17; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 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. 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 oira_ submission@omb.eop.gov. 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. SUMMARY: E:\FR\FM\18JYN1.SGM 18JYN1 Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices 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, PRAStaff@fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: 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 32835 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 records per recordkeeper Number of recordkeepers 21 CFR section Total annual records Average burden per recordkeeping Total hours 226.42, requires records be prepared and 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 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 packaging and labeling of Type A medicated articles. 226.102, requires maintenance of master-formula and batch-production records for Type A medicated articles. 226.110, requires maintenance of distribution records (2 years) for each shipment of Type A medicated articles for recall purposes. 226.115, requires maintenance of complaint files for Type A medicated articles for 2 years. 65 260 16,900 0.75 (45 minutes) ...... 12,675 65 260 16,900 1.75 ........................... 29,575 65 260 16,900 0.75 (45 minutes) ...... 12,675 65 260 16,900 1.75 ........................... 29,575 65 260 16,900 .25 (15 minutes) ........ 4,225 65 10 650 .5 (30 minutes) .......... 325 Total .................................................................. ........................ ........................ ........................ .................................... 76, 375 sradovich on DSK3GMQ082PROD with NOTICES 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, VerDate Sep<11>2014 17:47 Jul 17, 2017 Jkt 241001 number of Type A medicated articles being manufactured, etc.) from our records and experience. The burden has not changed since the last OMB approval. PO 00000 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 Frm 00051 Fmt 4703 Sfmt 9990 E:\FR\FM\18JYN1.SGM 18JYN1

Agencies

[Federal Register Volume 82, Number 136 (Tuesday, July 18, 2017)]
[Notices]
[Pages 32834-32835]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: 202-395-7285, or emailed to oira_submission@omb.eop.gov. 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,
PRAStaff@fda.hhs.gov.

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

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