81 FR 71508 - Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds
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 | 71508-71510 | |
| FR Document | 2016-25041 |
[Federal Register Volume 81, Number 200 (Monday, October 17, 2016)] [Notices] [Pages 71508-71510] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-25041] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0601] Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds 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 medicated animal feeds. 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-0601 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds.'' 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 [[Page 71509]] 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/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 Medicated Feeds--21 CFR Part 225 OMB Control Number 0910-0152--Extension Under section 501 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 351), FDA has the statutory authority to issue current good manufacturing practice (cGMP) regulations for drugs, including medicated feeds. Medicated feeds are administered to animals for the prevention, cure, mitigation, or treatment of disease, or growth promotion and feed efficiency. Statutory requirements for cGMPs have been codified under part 225 (21 CFR part 225). Medicated feeds that are not manufactured in accordance with these regulations are considered adulterated under section 501(a)(2)(B) of the FD&C Act. Under part 225, a manufacturer is required to establish, maintain, and retain records for a medicated feed, including records to document procedures required during 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), labels, and product distribution. This information is needed so that FDA can monitor drug usage and possible misformulation of medicated feeds to investigate violative drug residues in products from treated animals and to investigate product defects when a drug is recalled. In addition, FDA will use the cGMP criteria in part 225 to determine whether or not the systems and procedures used by manufacturers of medicated feeds are adequate to assure that their feeds meet the requirements of the FD&C Act as to safety, and also that they meet their claimed identity, strength, quality, and purity, as required by section 501(a)(2)(B) of the FD&C Act. A license is required when the manufacturer of a medicated feed involves the use of a drug or drugs that FDA has determined requires more control because of the need for a withdrawal period before slaughter or because of carcinogenic concerns. Conversely, a license is not required and the recordkeeping requirements are less demanding for those medicated feeds for which FDA has determined that the drugs used in their manufacture need less control. Respondents to this collection of information are commercial feed mills and mixer-feeders. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Recordkeeping Burden [Registered licensed commercial feed mills] \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of 21 CFR Section Number of records per Total annual Average burden per recordkeeper Total hours recordkeepers recordkeeper records -------------------------------------------------------------------------------------------------------------------------------------------------------- 225.42(b)(5) through (b)(8)................... 877 260 228,020 1....................................... 228,020 225.28(c) and (d)............................. 877 45 39,465 0.50 (30 minutes)....................... 19,732.5 225.80(b)(2).................................. 877 1,600 1,403,200 0.12 (7 minutes)........................ 168,384 225.102(b)(1)................................. 877 7,800 6,840,600 0.08 (5 minutes)........................ 547,248 225.110(b)(1) and (b)(2)...................... 877 7,800 6,840,600 0.02 (1 minute)......................... 136,812 225.115(b)(1) and (b)(2)...................... 877 5 4,385 0.12 (7 minutes)........................ 526.2 --------------------------------------------------------------------------------------------------------- Total..................................... .............. .............. .............. ........................................ 1,100,722.7 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. [[Page 71510]] Table 2--Estimated Annual Recordkeeping Burden [Registered licensed mixer-feeders] \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of 21 CFR Section Number of records per Total annual Average burden per recordkeeper Total hours recordkeepers recordkeeper records -------------------------------------------------------------------------------------------------------------------------------------------------------- 225.42(b) through (b)(8)...................... 100 260 26,000 0.15 (9 minutes)........................ 3,900 225.58(c) through (d)......................... 100 36 3,600 0.50 (30 minutes)....................... 1,800 225.80(b) (2)................................. 100 48 4,800 0.12 (7 minutes)........................ 576 225.102(b)(1) through (b)(5).................. 100 260 26,000 0.40 (24 minutes)....................... 10,400 --------------------------------------------------------------------------------------------------------- Total..................................... .............. .............. .............. ........................................ 16,676 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Table 3--Estimated Annual Recordkeeping Burden [Nonregistered unlicensed commercial feed mills] \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of 21 CFR Section Number of records per Total annual Average burden per recordkeeper Total hours recordkeepers recordkeeper records -------------------------------------------------------------------------------------------------------------------------------------------------------- 225.142....................................... 4,186 4 16,744 1....................................... 16,744 225.158....................................... 4,186 1 4,186 4....................................... 16,744 225.180....................................... 4,186 96 401,856 0.12 (7 minutes)........................ 48,223 225.202....................................... 4,186 260 1,088,360 0.65 (39 minutes)....................... 707,434 --------------------------------------------------------------------------------------------------------- Total..................................... .............. .............. .............. ........................................ 789,145 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Table 4--Estimated Annual Recordkeeping Burden [Nonregistered unlicensed mixer-feeders] \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of 21 CFR Section Number of records per Total annual Average burden per recordkeeper Total hours recordkeepers recordkeeper records -------------------------------------------------------------------------------------------------------------------------------------------------------- 225.142....................................... 3,400 4 13,600 1....................................... 13,600 225.158....................................... 3,400 1 3,400 4....................................... 13,600 225.180....................................... 3,400 32 108,800 0.12 (7 minutes)........................ 13,056 225.202....................................... 3,400 260 884,000 0.33 (20 minutes)....................... 291,720 --------------------------------------------------------------------------------------------------------- Total..................................... .............. .............. .............. ........................................ 331,976 -------------------------------------------------------------------------------------------------------------------------------------------------------- \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 Agency communications with industry. Other information needed to finally calculate the total burden hours (i.e., number of recordkeepers, number of medicated feeds being manufactured, etc.) is derived from Agency records and experience. Dated: October 12, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-25041 Filed 10-14-16; 8:45 am] BILLING CODE 4164-01-P
![71508 Federal Register / Vol. 81, No. 200 / Monday, October 17, 2016 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Total Average
Number of Total
21 CFR section; activity responses per annual burden per
respondents hours
respondent responses response
740(d)(1)(A); significant barrier to innova- 55 1 time for each application 55 2 ............................ 110
tion.
740(d)(1)(B); fees exceed cost ................ 8 3.75 .................................... 30 0.5 (30 minutes) .... 15
740(d)(1)(C); free choice feeds ................ 5 1 time for each application 5 2 ............................ 10
740(d)(1)(D); minor use or minor species 69 1 time for each application 69 2 ............................ 138
740(d)(1)(E); small business .................... 1 1 time for each application 1 2 ............................ 2
Request for reconsideration of a decision 1 1 time for each application 1 2 ............................ 2
Request for review (user fee appeal offi- 0 1 time for each application 0 0 ............................ 0
cer).
Total .................................................. ........................ ............................................ ........................ ............................... 277
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on FDA’s database system, from DATES: Submit either electronic or except for information submitted,
fiscal year (FY) 2014 to 2016 there were written comments on the collection of marked and identified, as confidential,
an estimated 177 sponsors subject to information by December 16, 2016. if submitted as detailed in
ADUFA. However, not all sponsors will ADDRESSES: You may submit comments ‘‘Instructions.’’
have any submissions in a given year as follows: Instructions: All submissions received
and some may have multiple must include the Docket No. FDA–
submissions. The total number of Electronic Submissions 2010–N–0601 for ‘‘Agency Information
waiver requests is based on the average Submit electronic comments in the Collection Activities; Proposed
number of submission types received by following way: Collection; Comment Request; Current
FDA in FY 2014 to 2016. • Federal eRulemaking Portal: http:// Good Manufacturing Practice
www.regulations.gov. Follow the Regulations for Medicated Feeds.’’
Dated: October 12, 2016.
instructions for submitting comments. Received comments will be placed in
Leslie Kux,
Comments submitted electronically, the docket and, except for those
Associate Commissioner for Policy. submitted as ‘‘Confidential
including attachments, to http://
[FR Doc. 2016–25040 Filed 10–14–16; 8:45 am] Submissions,’’ publicly viewable at
www.regulations.gov will be posted to
BILLING CODE 4164–01–P
the docket unchanged. Because your http://www.regulations.gov or at the
comment will be made public, you are Division of Dockets Management
solely responsible for ensuring that your between 9 a.m. and 4 p.m., Monday
DEPARTMENT OF HEALTH AND through Friday.
comment does not include any
HUMAN SERVICES • Confidential Submissions—To
confidential information that you or a
third party may not wish to be posted, submit a comment with confidential
Food and Drug Administration
such as medical information, your or information that you do not wish to be
[Docket No. FDA–2010–N–0601] anyone else’s Social Security number, or made publicly available, submit your
confidential business information, such comments only as a written/paper
Agency Information Collection submission. You should submit two
as a manufacturing process. Please note
Activities; Proposed Collection; copies total. One copy will include the
that if you include your name, contact
Comment Request; Current Good information you claim to be confidential
information, or other information that
Manufacturing Practice Regulations for with a heading or cover note that states
identifies you in the body of your
Medicated Feeds ‘‘THIS DOCUMENT CONTAINS
comments, that information will be
AGENCY: Food and Drug Administration, posted on http://www.regulations.gov. CONFIDENTIAL INFORMATION.’’ The
HHS. • If you want to submit a comment Agency will review this copy, including
ACTION: Notice. with confidential information that you the claimed confidential information, in
do not wish to be made available to the its consideration of comments. The
SUMMARY: The Food and Drug public, submit the comment as a second copy, which will have the
Administration (FDA) is announcing an written/paper submission and in the claimed confidential information
opportunity for public comment on the manner detailed (see ‘‘Written/Paper redacted/blacked out, will be available
proposed collection of certain Submissions’’ and ‘‘Instructions’’). for public viewing and posted on http://
information by the Agency. Under the www.regulations.gov. Submit both
Paperwork Reduction Act of 1995 (the Written/Paper Submissions copies to the Division of Dockets
PRA), Federal Agencies are required to Submit written/paper submissions as Management. If you do not wish your
publish notice in the Federal Register follows: name and contact information to be
concerning each proposed collection of • Mail/Hand delivery/Courier (for made publicly available, you can
information, including each proposed written/paper submissions): Division of provide this information on the cover
jstallworth on DSK7TPTVN1PROD with NOTICES
extension of an existing collection of Dockets Management (HFA–305), Food sheet and not in the body of your
information, and to allow 60 days for and Drug Administration, 5630 Fishers comments and you must identify this
public comment in response to the Lane, Rm. 1061, Rockville, MD 20852. information as ‘‘confidential.’’ Any
notice. This notice solicits comments on • For written/paper comments information marked as ‘‘confidential’’
the recordkeeping requirements for submitted to the Division of Dockets will not be disclosed except in
manufacturers of medicated animal Management, FDA will post your accordance with 21 CFR 10.20 and other
feeds. comment, as well as any attachments, applicable disclosure law. For more
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![Federal Register / Vol. 81, No. 200 / Monday, October 17, 2016 / Notices 71509
information about FDA’s posting of With respect to the following including records to document
comments to public dockets, see 80 FR collection of information, FDA invites procedures required during the
56469, September 18, 2015, or access comments on these topics: (1) Whether manufacturing process to assure that
the information at: http://www.fda.gov/ the proposed collection of information proper quality control is maintained.
regulatoryinformation/dockets/ is necessary for the proper performance Such records would, for example,
default.htm. of FDA’s functions, including whether contain information concerning receipt
Docket: For access to the docket to the information will have practical and inventory of drug components,
read background documents or the utility; (2) the accuracy of FDA’s batch production, laboratory assay
electronic and written/paper comments estimate of the burden of the proposed results (i.e. batch and stability testing),
received, go to http:// collection of information, including the labels, and product distribution.
www.regulations.gov and insert the validity of the methodology and
docket number, found in brackets in the This information is needed so that
assumptions used; (3) ways to enhance
heading of this document, into the FDA can monitor drug usage and
the quality, utility, and clarity of the
‘‘Search’’ box and follow the prompts information to be collected; and (4) possible misformulation of medicated
and/or go to the Division of Dockets ways to minimize the burden of the feeds to investigate violative drug
Management, 5630 Fishers Lane, Rm. collection of information on residues in products from treated
1061, Rockville, MD 20852. respondents, including through the use animals and to investigate product
FOR FURTHER INFORMATION CONTACT: FDA of automated collection techniques, defects when a drug is recalled. In
PRA Staff, Office of Operations, Food when appropriate, and other forms of addition, FDA will use the cGMP
and Drug Administration, Three White information technology. criteria in part 225 to determine
Flint North, 10A63, 11601 Landsdown whether or not the systems and
St., North Bethesda, MD 20852, Current Good Manufacturing Practice procedures used by manufacturers of
PRAStaff@fda.hhs.gov. Regulations for Medicated Feeds—21 medicated feeds are adequate to assure
SUPPLEMENTARY INFORMATION: Under the
CFR Part 225 that their feeds meet the requirements of
PRA (44 U.S.C. 3501–3520), Federal OMB Control Number 0910–0152— the FD&C Act as to safety, and also that
Agencies must obtain approval from the Extension they meet their claimed identity,
Office of Management and Budget strength, quality, and purity, as required
(OMB) for each collection of Under section 501 of the Federal by section 501(a)(2)(B) of the FD&C Act.
information they conduct or sponsor. Food, Drug, and Cosmetic Act (the A license is required when the
‘‘Collection of information’’ is defined FD&C Act) (21 U.S.C. 351), FDA has the manufacturer of a medicated feed
in 44 U.S.C. 3502(3) and 5 CFR statutory authority to issue current good involves the use of a drug or drugs that
1320.3(c) and includes Agency requests manufacturing practice (cGMP) FDA has determined requires more
or requirements that members of the regulations for drugs, including control because of the need for a
public submit reports, keep records, or medicated feeds. Medicated feeds are withdrawal period before slaughter or
provide information to a third party. administered to animals for the
because of carcinogenic concerns.
Section 3506(c)(2)(A) of the PRA (44 prevention, cure, mitigation, or
Conversely, a license is not required and
U.S.C. 3506(c)(2)(A)) requires Federal treatment of disease, or growth
the recordkeeping requirements are less
Agencies to provide a 60-day notice in promotion and feed efficiency. Statutory
demanding for those medicated feeds
the Federal Register concerning each requirements for cGMPs have been
for which FDA has determined that the
proposed collection of information, codified under part 225 (21 CFR part
including each proposed extension of an 225). Medicated feeds that are not drugs used in their manufacture need
existing collection of information, manufactured in accordance with these less control. Respondents to this
before submitting the collection to OMB regulations are considered adulterated collection of information are
for approval. To comply with this under section 501(a)(2)(B) of the FD&C commercial feed mills and mixer-
requirement, FDA is publishing notice Act. Under part 225, a manufacturer is feeders.
of the proposed collection of required to establish, maintain, and FDA estimates the burden of this
information set forth in this document. retain records for a medicated feed, collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN
[Registered licensed commercial feed mills] 1
Number of Average
Number of Total annual
21 CFR Section records per burden per Total hours
recordkeepers records
recordkeeper recordkeeper
225.42(b)(5) through (b)(8) .......................................... 877 260 228,020 1 ............................ 228,020
225.28(c) and (d) .......................................................... 877 45 39,465 0.50 (30 minutes) .. 19,732.5
225.80(b)(2) .................................................................. 877 1,600 1,403,200 0.12 (7 minutes) .... 168,384
225.102(b)(1) ................................................................ 877 7,800 6,840,600 0.08 (5 minutes) .... 547,248
225.110(b)(1) and (b)(2) ............................................... 877 7,800 6,840,600 0.02 (1 minute) ..... 136,812
225.115(b)(1) and (b)(2) ............................................... 877 5 4,385 0.12 (7 minutes) .... 526.2
jstallworth on DSK7TPTVN1PROD with NOTICES
Total ...................................................................... ........................ ........................ ........................ ............................... 1,100,722.7
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
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![71510 Federal Register / Vol. 81, No. 200 / Monday, October 17, 2016 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN
[Registered licensed mixer-feeders] 1
Number of Average
Number of Total annual
21 CFR Section records per burden per Total hours
recordkeepers records
recordkeeper recordkeeper
225.42(b) through (b)(8) ............................................... 100 260 26,000 0.15 (9 minutes) .... 3,900
225.58(c) through (d) ................................................... 100 36 3,600 0.50 (30 minutes) .. 1,800
225.80(b) (2) ................................................................. 100 48 4,800 0.12 (7 minutes) .... 576
225.102(b)(1) through (b)(5) ........................................ 100 260 26,000 0.40 (24 minutes) .. 10,400
Total ...................................................................... ........................ ........................ ........................ ............................... 16,676
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL RECORDKEEPING BURDEN
[Nonregistered unlicensed commercial feed mills] 1
Number of Average
Number of Total annual
21 CFR Section records per burden per Total hours
recordkeepers records
recordkeeper recordkeeper
225.142 ......................................................................... 4,186 4 16,744 1 ............................ 16,744
225.158 ......................................................................... 4,186 1 4,186 4 ............................ 16,744
225.180 ......................................................................... 4,186 96 401,856 0.12 (7 minutes) .... 48,223
225.202 ......................................................................... 4,186 260 1,088,360 0.65 (39 minutes) .. 707,434
Total ...................................................................... ........................ ........................ ........................ ............................... 789,145
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 4—ESTIMATED ANNUAL RECORDKEEPING BURDEN
[Nonregistered unlicensed mixer-feeders] 1
Number of Average
Number of Total annual
21 CFR Section records per burden per Total hours
recordkeepers records
recordkeeper recordkeeper
225.142 ......................................................................... 3,400 4 13,600 1 ............................ 13,600
225.158 ......................................................................... 3,400 1 3,400 4 ............................ 13,600
225.180 ......................................................................... 3,400 32 108,800 0.12 (7 minutes) .... 13,056
225.202 ......................................................................... 3,400 260 884,000 0.33 (20 minutes) .. 291,720
Total ...................................................................... ........................ ........................ ........................ ............................... 331,976
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The estimate of time required for DEPARTMENT OF HEALTH AND postmarket generic drug research
record preparation and maintenance is HUMAN SERVICES activities, public perceptions of generic
based on Agency communications with drug quality and effectiveness, and
industry. Other information needed to Food and Drug Administration verification of therapeutic equivalence
finally calculate the total burden hours [Docket No. FDA–2016–N–0001] of generic drugs. This workshop will
(i.e., number of recordkeepers, number also give stakeholders, including
of medicated feeds being manufactured, Substitutability of Generic Drugs: scientists from government, academia,
etc.) is derived from Agency records and Perceptions and Reality; Public and industry, patient advocacy groups,
experience. Workshop clinicians, pharmacists, and the general
public an opportunity to provide their
Dated: October 12, 2016. AGENCY: Food and Drug Administration, insights on future research needs in
Leslie Kux, HHS. postmarket surveillance of generic
Associate Commissioner for Policy. ACTION: Notice of public workshop. drugs.
[FR Doc. 2016–25041 Filed 10–14–16; 8:45 am] SUMMARY: The Food and Drug DATES: The public workshop will be
BILLING CODE 4164–01–P Administration (FDA), in collaboration held on November 18, 2016, from 8:30
with the Johns Hopkins University a.m. to 4:30 p.m.
Center of Excellence in Regulatory ADDRESSES: The public workshop will
jstallworth on DSK7TPTVN1PROD with NOTICES
Science and Innovation, is announcing be held at FDA’s White Oak Campus,
a public workshop entitled 10903 New Hampshire Ave., Building
‘‘Substitutability of Generic Drugs: 31 Conference Center, the Great Room
Perceptions and Reality.’’ The objective (Rm. 1503), Silver Spring, MD 20993.
of this workshop is to discuss FDA and Entrance for the public meeting
industry practices related to postmarket participants (non-FDA employees) is
surveillance of generic drugs, through Building 1 where routine
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Document Created: 2016-10-15 01:52:15
Document Modified: 2016-10-15 01:52:15
| 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 71508 |
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