81 FR 12509 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medicated Feed Mill License Application
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 46 (March 9, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 46 (March 9, 2016)
| Page Range | 12509-12511 | |
| FR Document | 2016-05214 |
[Federal Register Volume 81, Number 46 (Wednesday, March 9, 2016)] [Notices] [Pages 12509-12511] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-05214] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0511] Agency Information Collection Activities; Proposed Collection; Comment Request; Medicated Feed Mill License Application AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, we) 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 collection of information associated with Medicated Feed Mill License Applications. DATES: Submit either electronic or written comments on the collection of information by May 9, 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''). [[Page 12510]] 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-2009-N-0511 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Medicated Feed Mill License Application.'' 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/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, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [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. Medicated Feed Mill License Application--21 CFR Part 5157--OMB Control Number 0910-0337--Revision Feed manufacturers that seek to manufacture feed using Category II, Type A medicated articles or manufacture certain liquid and free-choice feed, using Category I, Type A medicated articles that must follow proprietary formulas or specifications are required to obtain a facility license under section 512 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360b). Our regulations in part 515 (21 CFR part 515) establish the procedures associated with applying for a facility license. We require that a manufacturer seeking a facility license submit a completed medicated feed mill license application using Form FDA 3448 (21 CFR 515.10(b)). We use the information submitted to establish that the applicant has made the certifications required by section 512 of the FD&C Act, to register the mill, and to schedule a pre-approval inspection. We have made minor editorial revisions to Form FDA 3448, including the addition of a dedicated field for the submitter's email address in the contact information section. We estimate that the revisions will not change the amount of time necessary to complete the form. We require the submission of a supplemental medicated feed mill license application for a change in facility ownership or a change in facility address (21 CFR 515.11(b)). If a licensed facility is no longer manufacturing medicated animal feed under 21 CFR 515.23, a manufacturer may request voluntary revocation of a medicated feed mill license. An applicant also has the right to file a request for hearing under 21 CFR 515.30(c) to give reasons why a medicated feed mill license should not be refused or revoked. We estimate the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of 21 CFR section and activity Number of responses per Total annual Average burden per response Total hours respondents respondent responses -------------------------------------------------------------------------------------------------------------------------------------------------------- Medicated Feed Mill License Application Using 20 1 20 0.25 (15 minutes)...................... 5 Form FDA 3448 (515.10(b)). [[Page 12511]] Supplemental Feed Mill License Application 40 1 40 0.25 (15 minutes)...................... 10 Using Form FDA 3448 (515.11(b)). Voluntary Revocation of Medicated Feed Mill 40 1 40 0.25 (15 minutes)...................... 10 License (515.23). Filing a Request for a Hearing on Medicated 1 1 1 4...................................... 4 Feed Mill License (515.30(c)). -------------------------------------------------------------------------------------------------------- Total...................................... .............. .............. .............. ....................................... 29 -------------------------------------------------------------------------------------------------------------------------------------------------------- \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 21 CFR section and activity Number of records per Total annual Average burden per recordkeeping Total hours recordkeepers recordkeeper records -------------------------------------------------------------------------------------------------------------------------------------------------------- Maintenance of Records for Approved Labeling 890 1 890 0.03 (2 minutes)....................... 26.7 for Each ``Type B'' and ``Type C'' Feed (510.305). -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. These estimates are based on our experience with medicated feed mill license applications. We estimate that we will receive 20 medicated feed mill license applications, 40 supplemental applications, 40 requests for voluntary revocation, and that these submissions will take approximately 15 minutes per response, as shown in table 1, rows 1 through 3. We estimate that preparing a request for a hearing under 21 CFR 515.30(c) takes approximately 4 hours, as shown in table 1, row 4. In table 2, we estimate that 890 licensees will keep the records required by 21 CFR 510.305 expending a total of 26.7 hours annually. Dated: March 2, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-05214 Filed 3-8-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 46 / Wednesday, March 9, 2016 / Notices 12509
Send one self-addressed adhesive label person and is not binding on FDA or the DEPARTMENT OF HEALTH AND
to assist that office in processing your public. You can use an alternative HUMAN SERVICES
requests. See the SUPPLEMENTARY approach if it satisfies the requirements
INFORMATION section for electronic of the applicable statutes and Food and Drug Administration
access to the draft guidance document. regulations. [Docket No. FDA–2009–N–0511]
FOR FURTHER INFORMATION CONTACT:
Rosemary Addy, Center for Drug II. The Paperwork Reduction Act of Agency Information Collection
Evaluation and Research, Food and 1995 Activities; Proposed Collection;
Drug Administration, 10903 New This draft guidance includes Comment Request; Medicated Feed
Hampshire Ave., Bldg. 22, Rm. 6430, Mill License Application
information collection provisions that
Silver Spring, MD 20993–0002, 301– are subject to review by the Office of AGENCY: Food and Drug Administration,
796–1640; or Stephen Ripley, Center for Management and Budget (OMB) under HHS.
Biologics Evaluation and Research,
the Paperwork Reduction Act of 1995 ACTION: Notice.
Food and Drug Administration, 10903
(44 U.S.C. 3501–3520). The collections
New Hampshire Ave., Bldg. 71, Rm. SUMMARY: The Food and Drug
7301, Silver Spring, MD 20993–0002, of information referenced in this draft
Administration (FDA, we) is
240–402–7911. guidance that are related to the burden
announcing an opportunity for public
on the submission of investigational
SUPPLEMENTARY INFORMATION: comment on the proposed collection of
new drug applications are covered
certain information by the Agency.
I. Background under 21 CFR part 312, including plans Under the Paperwork Reduction Act of
FDA is announcing the availability of for pediatric studies under 21 CFR 1995 (the PRA), Federal Agencies are
a draft guidance for industry entitled 312.47(b)(1)(iv) and waiver requests required to publish notice in the
‘‘Pediatric Study Plans: Content of and under 21 CFR 312.10, and have been Federal Register concerning each
Process for Submitting Initial Pediatric approved under OMB control number proposed collection of information,
Study Plans and Amended Initial 0910–0014. The collections of including each proposed extension of an
Pediatric Study Plans.’’ The purpose of information referenced in this draft existing collection of information, and
this draft guidance is to assist sponsors guidance that are related to the burden to allow 60 days for public comment in
in the submission of an iPSP and any on the submission of new drug response to the notice. This notice
amendments to an iPSP. Specifically, applications are covered under 21 CFR solicits comments on the collection of
this guidance addresses FDA’s current part 314, including pediatric use information associated with Medicated
thinking regarding the requirement for information under 21 CFR 314.50(d)(7) Feed Mill License Applications.
sponsors to submit an iPSP under and waiver requests under 21 CFR DATES: Submit either electronic or
section 505B of the FD&C Act (21 U.S.C. 314.90, and have been approved under written comments on the collection of
355c) as amended by FDASIA. OMB control number 0910–0001. The information by May 9, 2016.
This guidance revises the draft collections of information referenced in ADDRESSES: You may submit comments
guidance entitled ‘‘Pediatric Study this draft guidance that are related to the as follows:
Plans: Content of and Process for burden on the submission of biologics
Submitting Initial Pediatric Study Plans Electronic Submissions
license applications are covered under
and Amended Pediatric Study Plans’’ 21 CFR part 601, including pediatric use Submit electronic comments in the
issued July 15, 2013 (78 FR 42085). following way:
information and waiver requests under
Changes made in this draft guidance
21 CFR 601.27, and have been approved • Federal eRulemaking Portal: http://
were based largely on public comments www.regulations.gov. Follow the
under OMB control number 0910–0338.
received by FDA on the 2013 draft instructions for submitting comments.
guidance. III. Electronic Access Comments submitted electronically,
The following topics are addressed in including attachments, to http://
this draft guidance: (1) Who must Persons with access to the Internet www.regulations.gov will be posted to
submit an iPSP; (2) when an iPSP must may obtain the draft guidance at http:// the docket unchanged. Because your
be submitted; (3) what should be www.fda.gov/Drugs/Guidance comment will be made public, you are
included in an iPSP; (4) what should be ComplianceRegulatoryInformation/ solely responsible for ensuring that your
included in a requested amendment to Guidances/default.htm, http:// comment does not include any
an iPSP; (5) the relationship of an www.fda.gov/BiologicsBloodVaccines/ confidential information that you or a
agreed iPSP to the requirement to GuidanceComplianceRegulatory third party may not wish to be posted,
submit a pediatric study plan with a Information/default.htm, or http:// such as medical information, your or
marketing application; (6) what is meant www.regulations.gov. anyone else’s Social Security number, or
by a non-agreed iPSP; and (7) processes confidential business information, such
Dated: March 2, 2016.
for reaching agreement with FDA on a as a manufacturing process. Please note
non-agreed iPSP. This draft guidance Leslie Kux, that if you include your name, contact
also includes a revised template that Associate Commissioner for Policy. information, or other information that
should be used for submission of an [FR Doc. 2016–05223 Filed 3–8–16; 8:45 am] identifies you in the body of your
iPSP. BILLING CODE 4164–01–P comments, that information will be
This draft guidance is being issued posted on http://www.regulations.gov.
Lhorne on DSK5TPTVN1PROD with NOTICES
consistent with FDA’s good guidance • If you want to submit a comment
practices regulation (21 CFR 10.115). with confidential information that you
The draft guidance, when finalized, will do not wish to be made available to the
represent the current thinking of FDA public, submit the comment as a
on the content of and process for written/paper submission and in the
submitting iPSPs and amended iPSPs. It manner detailed (see ‘‘Written/Paper
does not establish any rights for any Submissions’’ and ‘‘Instructions’’).
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TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
Number of Total annual Average burden
21 CFR section and activity responses per Total hours
respondents responses per response
respondent
Supplemental Feed Mill License Application Using 40 1 40 0.25 (15 minutes) 10
Form FDA 3448 (515.11(b)).
Voluntary Revocation of Medicated Feed Mill License 40 1 40 0.25 (15 minutes) 10
(515.23).
Filing a Request for a Hearing on Medicated Feed Mill 1 1 1 4 ......................... 4
License (515.30(c)).
Total ......................................................................... ........................ ........................ ........................ ............................ 29
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 Average
Number of Total annual
21 CFR section and activity records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping
Maintenance of Records for Approved Labeling for 890 1 890 0.03 (2 minutes) 26.7
Each ‘‘Type B’’ and ‘‘Type C’’ Feed (510.305).
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
These estimates are based on our SUMMARY: The Food and Drug • Federal eRulemaking Portal: http://
experience with medicated feed mill Administration (FDA) is announcing the www.regulations.gov. Follow the
license applications. We estimate that following public workshop entitled instructions for submitting comments.
we will receive 20 medicated feed mill ‘‘Mass Spectrometry in the Clinic: Comments submitted electronically,
license applications, 40 supplemental Regulatory Considerations Surrounding including attachments, to http://
applications, 40 requests for voluntary Validation of Liquid Chromatography- www.regulations.gov will be posted to
revocation, and that these submissions Mass Spectrometry Based Devices.’’ The the docket unchanged. Because your
will take approximately 15 minutes per topics to be discussed are the specific comment will be made public, you are
response, as shown in table 1, rows 1 analytical and clinical study designs solely responsible for ensuring that your
through 3. We estimate that preparing a and considerations for validation and comment does not include any
request for a hearing under 21 CFR use of liquid chromatography/mass- confidential information that you or a
515.30(c) takes approximately 4 hours, spectrometry (LC/MS)-based in vitro third party may not wish to be posted,
as shown in table 1, row 4. In table 2, diagnostic devices (IVDs) in the clinical such as medical information, your or
we estimate that 890 licensees will keep laboratory. The primary focus will be on anyone else’s Social Security number, or
the records required by 21 CFR 510.305 the validation considerations with confidential business information, such
expending a total of 26.7 hours protein- and peptide-based LC/MS as a manufacturing process. Please note
annually. devices. that if you include your name, contact
Dated: March 2, 2016. information, or other information that
DATES: The public workshop will be
identifies you in the body of your
Leslie Kux, held on May 2, 2016, from 8:30 a.m. to
comments, that information will be
Associate Commissioner for Policy. 5 p.m. Submit either electronic or
posted on http://www.regulations.gov.
written comments on the public
[FR Doc. 2016–05214 Filed 3–8–16; 8:45 am]
• If you want to submit a comment
BILLING CODE 4164–01–P workshop by April 20, 2016.
with confidential information that you
ADDRESSES: The public workshop will do not wish to be made available to the
be held at FDA’s White Oak Campus, public, submit the comment as a
DEPARTMENT OF HEALTH AND 10903 New Hampshire Ave., Bldg. 31, written/paper submission and in the
HUMAN SERVICES Rm. 1503 (The Great Room), Silver manner detailed (see ‘‘Written/Paper
Spring, MD 20993. Entrance for the Submissions’’ and ‘‘Instructions’’).
Food and Drug Administration public meeting participants (non-FDA
employees) is through Building 1, where Written/Paper Submissions
[Docket No. FDA–2016–N–0610] routine security check procedures will Submit written/paper submissions as
be performed. For parking and security follows:
Mass Spectrometry in the Clinic: information, please refer to http:// • Mail/Hand delivery/Courier (for
Regulatory Considerations www.fda.gov/AboutFDA/ written/paper submissions): Division of
Surrounding Validation of Liquid WorkingatFDA/BuildingsandFacilities/ Dockets Management (HFA–305), Food
Chromatography-Mass Spectrometry WhiteOakCampusInformation/ and Drug Administration, 5630 Fishers
Based Devices; Public Workshop;
Lhorne on DSK5TPTVN1PROD with NOTICES
ucm241740.htm. Lane, Rm. 1061, Rockville, MD 20852.
Request for Comments You may submit comments as • For written/paper comments
AGENCY: Food and Drug Administration, follows: submitted to the Division of Dockets
HHS. Management, FDA will post your
Electronic Submissions
comment, as well as any attachments,
ACTION: Notice of public workshop;
Submit electronic comments in the except for information submitted,
request for comments.
following way: marked and identified, as confidential,
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Document Created: 2016-03-09 00:13:43
Document Modified: 2016-03-09 00:13:43
| 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 May 9, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 81 FR 12509 |
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