83 FR 24124 - Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 101 (May 24, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 101 (May 24, 2018)
| Page Range | 24124-24127 | |
| FR Document | 2018-11114 |
[Federal Register Volume 83, Number 101 (Thursday, May 24, 2018)] [Notices] [Pages 24124-24127] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-11114] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-1857] Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, [[Page 24125]] 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 information collection requirements associated with current good manufacturing practice, hazard analysis, and risk-based preventive controls for animal food. DATES: Submit either electronic or written comments on the collection of information by July 23, 2018. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before July 23, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of July 23, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, 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-2018-N-1857 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of 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 and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals--21 CFR Part 507 OMB Control Number 0910-0789--Extension The information collection supports FDA regulations. As amended by the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), the Federal Food, Drug, and Cosmetic Act (the FD&C Act) enables the Agency to better protect the public health by helping to ensure the safety and security of the food supply. It enables FDA to focus [[Page 24126]] more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. FSMA recognizes the important role industry plays in ensuring the safety of the food supply, including the adoption of modern systems of preventive controls in food production. Specifically, section 418 (21 U.S.C. 350g) of the FD&C Act sets forth requirements for hazard analysis and risk-based preventive controls for facilities that produce food for animals. To implement these provisions, regulations were codified under 21 CFR part 507-- Current Good Manufacturing Practice, Hazard Analysis, And Risk-Based Preventive Controls For Food For Animals. The regulations establish requirements for a written food safety plan; hazard analysis preventive controls; monitoring; corrective actions and corrections; verification; supply-chain program; recall plan; and associated records and became effective November 16, 2015. Currently, we continue to evaluate burden associated with the information collection requirements however, for purposes of extending the information collection we retain the currently approved figures as shown below. We estimate our burden of the information collection as follows: Table 1--Estimated Annual Reporting Burden for OMB Control No. 0910-0789 \1\ ---------------------------------------------------------------------------------------------------------------- Number of Number of responses Total Average burden per 21 CFR section; activity respondents per annual response Total hours respondent responses ---------------------------------------------------------------------------------------------------------------- 507.7 exemption: Submit attestation 1,120 0.5 560 0.5 (30 minutes)...... 280 of preventive controls or compliance with State and local laws (non-federal). 507.67, 507.69, and 507.71; 1 1 1 4..................... 4 submission of an appeal, including submission of a request for an informal hearing. 507.85(b); requests for 1 1 1 2..................... 2 reinstatement of exemption. --------------------------------------------------------------------------- Total........................... ........... ........... ........... ...................... 286 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Table 2--Estimated Annual Recordkeeping Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Number of responses Total Average burden per 21 CFR section; activity respondents per annual response Total hours respondent responses ---------------------------------------------------------------------------------------------------------------- Subpart A--General Provisions ---------------------------------------------------------------------------------------------------------------- 507.7(e); records attesting that the 1,120 0.5 560 0.1 (6 minutes)....... 56 facility is a ``qualified'' facility. 507.4(d); documentation of animal 7,469 0.75 5,579 0.05 (3 minutes)...... 279 food safety and hygiene training. ---------------------------------------------------------------------------------------------------------------- Subpart C--Hazard Analysis and Risk-Based Preventive Controls ---------------------------------------------------------------------------------------------------------------- 507.31 through 507.55; food safety 7,469 519 3,876,411 0.1 (6 minutes)....... 387,641 plan--including hazard analysis, preventive controls, monitoring, corrective actions, verification, validation reanalysis, modifications, and implementation records. ---------------------------------------------------------------------------------------------------------------- Subpart E--Supply-Chain Program ---------------------------------------------------------------------------------------------------------------- 507.105 through 507.175; written 7,469 519 3,876,411 0.1 (6 minutes)....... 387,641 supply-chain program--including records documenting program. ---------------------------------------------------------------------------------------------------------------- Subpart F--Requirements Applying to Records ---------------------------------------------------------------------------------------------------------------- 507.200 through 507.215; general 7,469 519 3,876,411 0.1 (6 minutes)....... 387,641 requirements, additional requirements applying to food safety plan, requirements for record retention, use of existing records, and special requirements applicable to written assurance. --------------------------------------------------------------------------- Totals.......................... ........... ........... 11,635,372 ...................... 1,163,258 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Table 3--Estimated Annual Third-Party Disclosure Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Number of responses Total Average burden per 21 CFR section; activity respondents per annual response Total hours respondent responses ---------------------------------------------------------------------------------------------------------------- 507.27(b); labeling for the animal 330 10 3,300 0.25 (15 minutes)..... 825 food product contains the specific information and instructions needed so the food can be safely used for the intended animal species. [[Page 24127]] 507.7(e)(1); change labels on 1,526 4 6,104 1..................... 6,104 products with labels. 507.7(e)(2); change address on 1,329 1 1,329 1..................... 1,329 labeling (sales documents) for qualified facilities. 507.25(a)(2); animal food, including 330 312 102,960 0.01 (36 seconds)..... 1,030 raw materials, other ingredients, and rework, is accurately identified. 507.28(b); holding and distribution 40,798 2 81,596 0.25 (15 minutes)..... 20,399 of human food byproducts for use as animal food. --------------------------------------------------------------------------- Total........................... ........... ........... ........... ...................... 29,687 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. These figures are based on our regulatory impact analysis in support of the final rule on Preventive Controls for Food for Animals, which published in the Federal Register of September 17, 2015 (80 FR 56170). Using Agency data we estimated the number of animal food facilities that we believe are subject to the regulations. We base our estimate of the time necessary for the individual reporting, recordkeeping, and third-party disclosure activities on our experience with similar information collections. Dated: May 18, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-11114 Filed 5-23-18; 8:45 am] BILLING CODE 4164-01-P
![24124 Federal Register / Vol. 83, No. 101 / Thursday, May 24, 2018 / Notices
enzootic status and genetic factors canine population. Determining a field studies where necropsy worm
affecting the disease in each location, population level endpoint would allow counts will not be performed.
thereby providing better inferential us to explore the suitability and 7. What are the most reliable ways of
value than the laboratory study. feasibility of alternative study designs properly classifying the outcome in a
Limitations of the field study are that for the evaluation of effectiveness for non-terminal study?
the exposure to infective D. immitis heartworm preventatives. Factors that 8. Are there critical pieces of
larvae is assumed, but uncertain, and, in may contribute to a heartworm information supporting substantial
cases of dogs with positive antigen tests, preventative’s effectiveness include the evidence of effectiveness that can only
the actual timing of the exposure is inherent potency of the drug, be gained from a well-controlled
unknown. Additionally, the relatively differences in heartworm susceptibility, laboratory study? Are there elements
short duration of the field study in and owner compliance. that could be added to a field study that
relationship to the heartworm life cycle 1. Assuming that a product was would partially address those data gaps?
and testing limitations may not administered according to labeled Other.
adequately evaluate the entire dosing directions, what would be an acceptable 9. Are there laboratory study designs
period of the investigational new animal rate of failure of an approved heartworm other than the traditional dose
drug. Assurance that individual dogs preventative in the overall United States confirmation study that provide
were exposed to D. immitis larvae canine population to which it is additional information or include a
during the critical first few months of administered? model that is more representative of real
the study is lacking, which complicates 2. What would be the maximum world exposure? For example, the use of
interpretation of a negative antigen test acceptable rate of failure in a high-risk live mosquitoes to induce infection
at the end of the study. If the study is population? rather than the mechanical injection of
started during a time of low 3. Alternatively, if you do not have a larvae.
transmission, such as in winter, numerical estimate, what 10. How might differences in the
exposure is even more uncertain. recommendations do you have for route of administration, dosing
Because of the delay in the ability to determining what an acceptable rate of frequency, or pharmacokinetic factors
detect an adult heartworm infection, it failure should be? impact effectiveness? How might
is impossible to tell with certainty if Exposure to infective D. immitis
studies be designed to incorporate these
infections detected between 4 and 8 larvae. For humane reasons, field
factors? For example, a drug that
months after study initiation were pre- studies are not conducted with a
demonstrates an early peak, with
existing infections or due to lack of negative control group that would
minimal to no drug levels in the dog for
effectiveness of the preventative. reflect the study population’s level of
the remainder of the dosing interval
Obtaining false negative and false exposure to heartworm infection.
versus a product with continuous drug
positive antigen test results are possible Therefore, it is necessary to have other
levels in the dog for the entire dosing
and, because worm counts are not measures to ensure that the level of
interval?
performed, the false results may result exposure to infective D. immitis larvae
in the misclassification of outcome for experienced in the study is sufficient to Dated: May 21, 2018.
individual dogs. adequately test the effectiveness of the Leslie Kux,
In recognition of the limitations of the investigational new animal drug. Please Associate Commissioner for Policy.
current recommended laboratory and provide comment on other methods that [FR Doc. 2018–11132 Filed 5–23–18; 8:45 am]
field effectiveness studies for heartworm could reliably be used to ensure BILLING CODE 4164–01–P
preventatives for use in dogs, we are adequate exposure of dogs enrolled in a
interested in evaluating alternative field study. Consider the following
approaches to these study designs that points: DEPARTMENT OF HEALTH AND
would mitigate the limitations of such 4. Can available tests be used to HUMAN SERVICES
studies while ensuring that the studies determine an individual dog’s exposure
generate data to support substantial to infective larvae? What are the Food and Drug Administration
evidence of effectiveness as defined in sensitivity and specificity of those tests [Docket No. FDA–2018–N–1857]
21 CFR 514.4. in this application? How would the
Currently, there are gaps in level of sensitivity and specificity of Agency Information Collection
knowledge and understanding that these tests impact the reliable Activities; Proposed Collection;
prevent us from fully evaluating assessment of rate of failure in the Comment Request; Current Good
alternative approaches to meeting the population? Manufacturing Practice, Hazard
substantial evidence of effectiveness 5. Does the use of a heartworm Analysis, and Risk-Based Preventive
standard. To address these gaps, we are preventative, even if only partially Controls for Food for Animals
seeking public comment regarding the effective, have an impact on the results
following questions: of these tests? AGENCY: Food and Drug Administration,
Population level effectiveness 6. Could methods that consider a HHS.
endpoint. The design and evaluation of wider area (as opposed to an individual ACTION: Notice.
effectiveness studies rely on an animal) such as mosquito testing,
understanding of the appropriate forecasting, or modeling be reliably used SUMMARY: The Food and Drug
outcome measure. In seeking to design to determine the likely exposure to Administration (FDA or Agency) is
alternative study approaches, we would announcing an opportunity for public
sradovich on DSK3GMQ082PROD with NOTICES
infective larvae of dogs at a specific
like to determine a population level study site? What information would be comment on the proposed collection of
effectiveness endpoint that could be needed to create the methods or to certain information by the Agency.
used to design future studies. Currently verify the validity of the methods? What Under the Paperwork Reduction Act of
we do not have a defined level of are the limitations to such an approach? 1995 (PRA), Federal Agencies are
performance that heartworm Outcome Assessment. Accurate required to publish notice in the
preventatives are expected to meet assessment of the outcome endpoint Federal Register concerning each
when applied to the entire United States (heartworm infection) is essential for proposed collection of information,
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![Federal Register / Vol. 83, No. 101 / Thursday, May 24, 2018 / Notices 24127
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Number of Average
Number of responses Total annual
21 CFR section; activity burden per Total hours
respondents per responses response
respondent
507.7(e)(1); change labels on products with labels ..................... 1,526 4 6,104 1 ............................ 6,104
507.7(e)(2); change address on labeling (sales documents) for 1,329 1 1,329 1 ............................ 1,329
qualified facilities.
507.25(a)(2); animal food, including raw materials, other ingredi- 330 312 102,960 0.01 (36 seconds) 1,030
ents, and rework, is accurately identified.
507.28(b); holding and distribution of human food byproducts for 40,798 2 81,596 0.25 (15 minutes) 20,399
use as animal food.
Total ....................................................................................... .................... .................... .................... ............................... 29,687
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
These figures are based on our OMB recommends that written prescription drug sample; (3) to limit
regulatory impact analysis in support of comments be faxed to the Office of the distribution of drug samples to
the final rule on Preventive Controls for Information and Regulatory Affairs, practitioners licensed or authorized to
Food for Animals, which published in OMB, Attn: FDA Desk Officer, Fax: 202– prescribe such drugs or to pharmacies of
the Federal Register of September 17, 395–7285, or emailed to oira_ hospitals or other healthcare entities at
2015 (80 FR 56170). Using Agency data submission@omb.eop.gov. All the request of a licensed or authorized
we estimated the number of animal food comments should be identified with the practitioner; (4) to require licensed or
facilities that we believe are subject to OMB control number 0910–0435. Also authorized practitioners to request
the regulations. We base our estimate of include the FDA docket number found prescription drug samples in writing; (5)
the time necessary for the individual in brackets in the heading of this to mandate storage, handling, and
reporting, recordkeeping, and third- document. recordkeeping requirements for
party disclosure activities on our FOR FURTHER INFORMATION CONTACT: prescription drug samples; (6) to
experience with similar information prohibit, with certain exceptions, the
Domini Bean, Office of Operations,
collections. sale, purchase, or trade, or the offer to
Food and Drug Administration, Three
Dated: May 18, 2018. White Flint North, 10A–12M, 11601 sell, purchase, or trade, of prescription
Leslie Kux, Landsdown St., North Bethesda, MD drugs that were purchased by hospitals
Associate Commissioner for Policy. 20852, 301–796–5733, PRAStaff@ or other healthcare entities or that were
[FR Doc. 2018–11114 Filed 5–23–18; 8:45 am] fda.hhs.gov. donated or supplied at a reduced price
to a charitable organization; and (7) to
BILLING CODE 4164–01–P SUPPLEMENTARY INFORMATION: In
require unauthorized wholesale
compliance with 44 U.S.C. 3507, FDA
distributors to provide, prior to the
has submitted the following proposed
DEPARTMENT OF HEALTH AND wholesale distribution of a prescription
collection of information to OMB for
HUMAN SERVICES drug to another wholesale distributor or
review and clearance.
retail pharmacy, a statement identifying
Food and Drug Administration Prescription Drug Marketing Act of each prior sale, purchase, or trade of the
[Docket No. FDA–2011–N–0279] 1987—Administrative Procedures, drug.
Policies, and Requirements In the Federal Register of December
Agency Information Collection OMB Control Number 0910–0435— 14, 2017 (82 FR 58808), we published a
Activities; Submission for Office of Extension notice soliciting public comment of the
Management and Budget Review; information collection. One caller
Comment Request; Prescription Drug This information collection supports
FDA regulations codified at part 203 (21 responded to the notice asking about the
Marketing; Administrative Procedures, impact the Drug Supply Chain Security
Policies, and Requirements CFR part 203) implementing the
Prescription Drug Marketing Act of 1987 Act (DSCSA) (Title II of the Drug
AGENCY: Food and Drug Administration, (PDMA). The PDMA was intended to Quality Security Act of 2013) has on the
HHS. ensure safe and effective drug products information collection. We note that the
ACTION: Notice. and to avoid an unacceptable risk that Agency is currently proposing to amend
counterfeit, adulterated, misbranded, its regulations at part 203 to reflect
SUMMARY: The Food and Drug subpotent, or expired drugs are sold to changes resulting from enactment of the
Administration (FDA) is announcing consumers. The reporting and DSCSA (RIN 0910–AH56). While we
that a proposed collection of recordkeeping requirements found in expect these changes will result in a
information has been submitted to the the regulations are intended to help reduction of burden associated with the
Office of Management and Budget achieve the following goals: (1) To ban information collection, current
(OMB) for review and clearance under regulations and associated information
sradovich on DSK3GMQ082PROD with NOTICES
the reimportation of prescription drugs
the Paperwork Reduction Act of 1995. produced in the United States, except collection requirements remain in effect.
DATES: Fax written comments on the when reimported by the manufacturer Upon finalization of rulemaking, we
collection of information by June 25, or under FDA authorization for will revise the information collection
2018. emergency medical care; (2) to ban the accordingly.
ADDRESSES: To ensure that comments on sale, purchase, or trade, or the offer to We therefore estimate the burden for
the information collection are received, sell, purchase, or trade, of any the information collection as follows:
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Document Created: 2018-05-24 00:05:40
Document Modified: 2018-05-24 00:05:40
| 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 July 23, 2018. | |
| Contact | Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected] | |
| FR Citation | 83 FR 24124 |
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