81 FR 71513 - Agency Information Collection Activities; Proposed Collection; 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 81, Issue 200 (October 17, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 200 (October 17, 2016)
| Page Range | 71513-71514 | |
| FR Document | 2016-25003 |
[Federal Register Volume 81, Number 200 (Monday, October 17, 2016)] [Notices] [Pages 71513-71514] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-25003] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0598] Agency Information Collection Activities; Proposed Collection; 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) 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 recordkeeping requirements for manufacturers of Type A medicated articles. DATES: Submit either electronic or written comments on the collection of information by December 16, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand Delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. [FDA-2010-N-0598] for ``[Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Type A Medicated Articles].'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/ [[Page 71514]] regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]. 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 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 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. This information is needed so that FDA can monitor drug usage and possible misformulation of Type A medicated articles. The information could also prove useful to FDA in investigating product defects when a drug is recalled. In addition, FDA 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. 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 Total hours recordkeepers recordkeeper records recordkeeping ---------------------------------------------------------------------------------------------------------------- 226.42.................. 65 260 16,900 0.75 (45 minutes)..... 12,675 226.58.................. 65 260 16,900 1.75 (1 hour, 45 29,575 minutes). 226.80.................. 65 260 16,900 0.75 (45 minutes)..... 12,675 226.102................. 65 260 16,900 1.75 (1 hour, 45 29,575 minutes). 226.110................. 65 260 16,900 .025 (15 minutes)..... 4,225 226.115................. 65 10 650 .5 (30 minutes)....... 325 --------------- Total............... .............. .............. .............. ...................... 89,050 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. The estimate of time required for record preparation and maintenance is based on previous Agency communications with industry. Other information needed to calculate the total burden hours (i.e., manufacturing sites, number of Type A medicated articles being manufactured, etc.) are derived from Agency records and experience. Dated: October 11, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-25003 Filed 10-14-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 200 / Monday, October 17, 2016 / Notices 71513
draft guidance to provide clarifying and DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper
explanatory information that will assist HUMAN SERVICES Submissions’’ and ‘‘Instructions’’).
human generic drug manufacturers with Written/Paper Submissions
PAS submissions. Changes from the Food and Drug Administration
draft guidance include clarification on Submit written/paper submissions as
[Docket No. FDA–2010–N–0598]
the point at which a PAS is deemed follows:
• Mail/Hand Delivery/Courier (for
submitted to FDA and a description of Agency Information Collection
written/paper submissions): Division of
the process through which applicants Activities; Proposed Collection;
Dockets Management (HFA–305), Food
may request FDA reconsider its Comment Request; Current Good
and Drug Administration, 5630 Fishers
supplement reporting category Manufacturing Practice Regulations for
Lane, Rm. 1061, Rockville, MD 20852.
determination. The draft guidance and Type A Medicated Articles • For written/paper comments
related public comments are publicly AGENCY: Food and Drug Administration, submitted to the Division of Dockets
available in Docket No. FDA–2014–D– HHS. Management, FDA will post your
0901. ACTION: Notice. comment, as well as any attachments,
This guidance is being issued except for information submitted,
consistent with FDA’s good guidance SUMMARY: The Food and Drug marked and identified, as confidential,
practices regulation (21 CFR 10.115). Administration (FDA) is announcing an if submitted as detailed in
opportunity for public comment on the ‘‘Instructions.’’
The guidance represents the current
proposed collection of certain Instructions: All submissions received
thinking of FDA on ‘‘ANDA must include the Docket No. [FDA–
Submissions—Prior Approval information by the Agency. Under the
Paperwork Reduction Act of 1995 (the 2010–N–0598] for ‘‘[Agency Information
Supplements Under GDUFA.’’ It does Collection Activities; Proposed
not establish any rights for any person PRA), Federal Agencies are required to
publish notice in the Federal Register Collection; Comment Request; Current
and is not binding on FDA or the public. Good Manufacturing Practice
concerning each proposed collection of
You can use an alternative approach if Regulations for Type A Medicated
information, including each proposed
it satisfies the requirements of the extension of an existing collection of Articles].’’ Received comments will be
applicable statutes and regulations. information, and to allow 60 days for placed in the docket and, except for
public comment in response to the those submitted as ‘‘Confidential
II. Paperwork Reduction Act of 1995
notice. This notice solicits comments on Submissions,’’ publicly viewable at
This guidance refers to previously the recordkeeping requirements for http://www.regulations.gov or at the
approved collections of information manufacturers of Type A medicated Division of Dockets Management
found in FDA regulations. These articles. between 9 a.m. and 4 p.m., Monday
collections of information are subject to through Friday.
DATES: Submit either electronic or • Confidential Submissions—To
review by the Office of Management and written comments on the collection of submit a comment with confidential
Budget (OMB) under the Paperwork information by December 16, 2016. information that you do not wish to be
Reduction Act of 1995 (44 U.S.C. 3501– made publicly available, submit your
ADDRESSES: You may submit comments
3520). The collections of information for as follows: comments only as a written/paper
supplements and amendments in 21 submission. You should submit two
CFR part 314 have been approved under Electronic Submissions copies total. One copy will include the
OMB control number 0910–0001. The Submit electronic comments in the information you claim to be confidential
collection of information for following way: with a heading or cover note that states
manufacturer registration in 21 CFR part • Federal eRulemaking Portal: http:// ‘‘THIS DOCUMENT CONTAINS
207 has been approved under OMB www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
control number 0910–0045. The instructions for submitting comments. Agency will review this copy, including
collection of information for Comments submitted electronically, the claimed confidential information, in
manufacturer compliance with current including attachments, to http:// its consideration of comments. The
good manufacturing practices in 21 CFR www.regulations.gov will be posted to second copy, which will have the
part 211 has been approved under OMB the docket unchanged. Because your claimed confidential information
control number 0910–0139. comment will be made public, you are redacted/blacked out, will be available
solely responsible for ensuring that your for public viewing and posted on http://
III. Electronic Access comment does not include any www.regulations.gov. Submit both
confidential information that you or a copies to the Division of Dockets
Persons with access to the Internet
third party may not wish to be posted, Management. If you do not wish your
may obtain the guidance at either http://
such as medical information, your or name and contact information to be
www.fda.gov/Drugs/Guidance
anyone else’s Social Security number, or made publicly available, you can
ComplianceRegulatoryInformation/ confidential business information, such provide this information on the cover
Guidances/default.htm, http:// as a manufacturing process. Please note sheet and not in the body of your
www.fda.gov/BiologicsBloodVaccines/ that if you include your name, contact comments and you must identify this
GuidanceComplianceRegulatory information, or other information that information as ‘‘confidential.’’ Any
information/Guidances/default.htm, or identifies you in the body of your information marked as ‘‘confidential’’
jstallworth on DSK7TPTVN1PROD with NOTICES
http://www.regulations.gov. comments, that information will be will not be disclosed except in
Dated: October 11, 2016. posted on http://www.regulations.gov. accordance with 21 CFR 10.20 and other
Leslie Kux, • If you want to submit a comment applicable disclosure law. For more
with confidential information that you information about FDA’s posting of
Associate Commissioner for Policy.
do not wish to be made available to the comments to public dockets, see 80 FR
[FR Doc. 2016–25037 Filed 10–14–16; 8:45 am]
public, submit the comment as a 56469, September 18, 2015, or access
BILLING CODE 4164–01–P written/paper submission and in the the information at: http://www.fda.gov/
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![71514 Federal Register / Vol. 81, No. 200 / Monday, October 17, 2016 / Notices
regulatoryinformation/dockets/ With respect to the following codified in part 226 (21 CFR part 226).
default.htm. collection of information, FDA invites Type A medicated articles which are not
Docket: For access to the docket to comments on these topics: (1) Whether manufactured in accordance with these
read background documents or the the proposed collection of information regulations are considered adulterated
electronic and written/paper comments is necessary for the proper performance under section 501(a)(2)(B) of the FD&C
received, go to http:// of FDA’s functions, including whether Act (21 U.S.C. 351(a)(2)(B). Under part
www.regulations.gov and insert the the information will have practical 226, a manufacturer is required to
docket number, found in brackets in the utility; (2) the accuracy of FDA’s establish, maintain, and retain records
heading of this document, into the estimate of the burden of the proposed for Type A medicated articles, including
‘‘Search’’ box and follow the prompts collection of information, including the records to document procedures
and/or go to the Division of Dockets validity of the methodology and required under the manufacturing
Management, 5630 Fishers Lane, Rm. assumptions used; (3) ways to enhance process to assure that proper quality
1061, Rockville, MD 20852. the quality, utility, and clarity of the control is maintained. Such records
information to be collected; and (4) would, for example, contain information
FOR FURTHER INFORMATION CONTACT: FDA ways to minimize the burden of the concerning receipt and inventory of
PRA Staff, Office of Operations, Food collection of information on drug components, batch production,
and Drug Administration, Three White respondents, including through the use laboratory assay results (i.e., batch and
Flint North, 10A63, 11601 Landsdown of automated collection techniques, stability testing), and product
St., North Bethesda, MD 20852, when appropriate, and other forms of distribution.
PRAStaff@fda.hhs.gov. information technology. This information is needed so that
SUPPLEMENTARY INFORMATION: Under the Current Good Manufacturing Practice FDA can monitor drug usage and
PRA (44 U.S.C. 3501–3520), Federal Regulations for Type A Medicated possible misformulation of Type A
Agencies must obtain approval from the Articles—21 CFR Part 226 OMB Control medicated articles. The information
Office of Management and Budget Number 0910–0154—Extension could also prove useful to FDA in
(OMB) for each collection of Under section 501 of the Federal investigating product defects when a
information they conduct or sponsor. Food, Drug, and Cosmetic Act (the drug is recalled. In addition, FDA will
‘‘Collection of information’’ is defined FD&C Act), FDA has the statutory use the cGMP criteria in part 226 to
in 44 U.S.C. 3502(3) and 5 CFR authority to issue current good determine whether or not the systems
1320.3(c) and includes Agency requests manufacturing practice (cGMP) used by manufacturers of Type A
or requirements that members of the regulations for drugs, including Type A medicated articles are adequate to
public submit reports, keep records, or medicated articles. A Type A medicated assure that their medicated articles meet
provide information to a third party. article is a feed product containing a the requirements of the FD&C Act as to
Section 3506(c)(2)(A) of the PRA (44 concentrated drug diluted with a feed safety and also meet the article’s
U.S.C. 3506(c)(2)(A)) requires Federal carrier substance. A Type A medicated claimed identity, strength, quality, and
Agencies to provide a 60-day notice in article is intended solely for use in the purity, as required by section
the Federal Register concerning each manufacture of another Type A 501(a)(2)(B) of the FD&C Act. The
proposed collection of information, medicated article or a Type B or Type respondents for Type A medicated
including each proposed extension of an C medicated feed. Medicated feeds are articles are pharmaceutical firms that
existing collection of information, administered to animals for the manufacture both human and veterinary
before submitting the collection to OMB prevention, cure, mitigation, or drugs, those firms that produce only
for approval. To comply with this treatment of disease or for growth veterinary drugs, and commercial feed
requirement, FDA is publishing notice promotion and feed efficiency. mills.
of the proposed collection of Statutory requirements for cGMPs for FDA estimates the burden of this
information set forth in this document. Type A medicated articles have been collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
21 CFR Number of Total annual
records per Average burden per recordkeeping Total hours
section recordkeepers records
recordkeeper
226.42 ......... 65 260 16,900 0.75 (45 minutes) ................................................................... 12,675
226.58 ......... 65 260 16,900 1.75 (1 hour, 45 minutes) ...................................................... 29,575
226.80 ......... 65 260 16,900 0.75 (45 minutes) ................................................................... 12,675
226.102 ....... 65 260 16,900 1.75 (1 hour, 45 minutes) ...................................................... 29,575
226.110 ....... 65 260 16,900 .025 (15 minutes) ................................................................... 4,225
226.115 ....... 65 10 650 .5 (30 minutes) ....................................................................... 325
Total ..... ........................ ........................ ........................ ................................................................................................ 89,050
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
jstallworth on DSK7TPTVN1PROD with NOTICES
The estimate of time required for being manufactured, etc.) are derived Dated: October 11, 2016.
record preparation and maintenance is from Agency records and experience. Leslie Kux,
based on previous Agency Associate Commissioner for Policy.
communications with industry. Other [FR Doc. 2016–25003 Filed 10–14–16; 8:45 am]
information needed to calculate the total BILLING CODE 4164–01–P
burden hours (i.e., manufacturing sites,
number of Type A medicated articles
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Document Created: 2016-10-15 01:52:13
Document Modified: 2016-10-15 01:52:13
| 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 | Submit either electronic or written comments on the collection of information by December 16, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected] | |
| FR Citation | 81 FR 71513 |
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