Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medicated Feed Mill License Application, 37602-37603 [2016-13790]

Download as PDF asabaliauskas on DSK3SPTVN1PROD with NOTICES 37602 Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Notices moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before June 28, 2016. Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 3 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before June 20, 2016. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by June 21, 2016. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Moon Hee Choi at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at VerDate Sep<11>2014 19:02 Jun 09, 2016 Jkt 238001 https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). SUPPLEMENTARY INFORMATION: Dated: June 6, 2016. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. Feed manufacturers that seek to manufacture feed using Category II, Type A medicated articles or manufacture certain liquid and freechoice 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 (§ 515.11(b)). If a licensed facility is no longer manufacturing medicated animal feed under § 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 § 515.30(c) to give reasons why a medicated feed mill license should not be refused or revoked. In the Federal Register of March 9, 2016 (81 FR 12509), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received one comment, which was not responsive to the comment request. We estimate the burden of this collection of information as follows: [FR Doc. 2016–13709 Filed 6–9–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0511] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medicated Feed Mill License Application AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by July 11, 2016. SUMMARY: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0337. Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Medicated Feed Mill License Application—21 CFR Part 515—OMB Control Number 0910–0337—Revision E:\FR\FM\10JNN1.SGM 10JNN1 Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Notices 37603 TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Medicated Feed Mill License Application using Form FDA 3448 (515.10(b)). Supplemental Feed Mill License Application using Form FDA 3448 (515.11(b)). Voluntary Revocation of Medicated Feed Mill License. (515.23) .................................................................... Filing a Request for a Hearing on Medicated Feed Mill License (515.30(c)). Total .................................................................. 1 There Number of responses per respondent Number of respondents 21 CFR section and activity Total annual responses Average burden per response Total hours 20 1 20 0.25 (15 minutes) ...... 5 40 1 40 0.25 (15 minutes) ...... 10 40 1 40 0.25 (15 minutes) ...... 10 1 1 1 4 ................................ 4 ........................ ........................ ........................ .................................... 29 are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers 21 CFR section and activity Maintenance of Records for Approved Labeling for Each ‘‘Type B’’ and ‘‘Type C’’ Feed (510.305). 1 There Dated: June 6, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–13790 Filed 6–9–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration asabaliauskas on DSK3SPTVN1PROD with NOTICES [Docket No. FDA–2016–D–1264] Dissemination of Patient-Specific Information From Devices by Device Manufacturers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Food and Drug Administration, HHS. ACTION: 890 Total annual records 1 890 Average burden per recordkeeping 0.03 (2 minutes) ........ Total hours 27 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 § 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 27 hours annually. AGENCY: Number of records per recordkeeper Notice of availability. VerDate Sep<11>2014 19:02 Jun 09, 2016 Jkt 238001 The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ‘‘Dissemination of Patient-Specific Information from Devices by Device Manufacturers.’’ The FDA developed this draft guidance to facilitate the appropriate and responsible dissemination of patientspecific information recorded, stored, processed, retrieved, and/or derived from medical devices from manufacturers to patients. This draft guidance provides recommendations to industry, healthcare providers, and FDA staff about the mechanisms and considerations for device manufacturers sharing such information with patients. This draft guidance is not final nor is it in effect at this time. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by August 9, 2016. ADDRESSES: You may submit comments as follows: SUMMARY: 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 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 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): 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.’’ E:\FR\FM\10JNN1.SGM 10JNN1

Agencies

[Federal Register Volume 81, Number 112 (Friday, June 10, 2016)]
[Notices]
[Pages 37602-37603]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13790]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0511]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medicated Feed Mill
License Application

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by July
11, 2016.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0337.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Medicated Feed Mill License Application--21 CFR Part 515--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 (Sec. 515.11(b)). If a licensed facility is no longer
manufacturing medicated animal feed under Sec. 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 Sec.
515.30(c) to give reasons why a medicated feed mill license should not
be refused or revoked.
In the Federal Register of March 9, 2016 (81 FR 12509), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received one comment, which was not
responsive to the comment request.
We estimate the burden of this collection of information as
follows:

[[Page 37603]]

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 20 1 20 0.25 (15 minutes)......................... 5
using Form FDA 3448 (515.10(b)).
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).......................... 27
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
Sec. 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 27 hours annually.

Dated: June 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-13790 Filed 6-9-16; 8:45 am]
BILLING CODE 4164-01-P

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