81 FR 37602 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medicated Feed Mill License Application
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 112 (June 10, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 112 (June 10, 2016)
| Page Range | 37602-37603 | |
| FR Document | 2016-13790 |
[Federal Register Volume 81, Number 112 (Friday, June 10, 2016)] [Notices] [Pages 37602-37603] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-13790] ----------------------------------------------------------------------- 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 [email protected]. 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, [email protected]. 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
![37602 Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Notices
moderate to severe plaque psoriasis who http://www.fda.gov/ SUPPLEMENTARY INFORMATION: In
are candidates for systemic therapy or AdvisoryCommittees/ compliance with 44 U.S.C. 3507, FDA
phototherapy. AboutAdvisoryCommittees/ has submitted the following proposed
FDA intends to make background ucm111462.htm for procedures on collection of information to OMB for
material available to the public no later public conduct during advisory review and clearance.
than 2 business days before the meeting. committee meetings.
Medicated Feed Mill License
If FDA is unable to post the background Notice of this meeting is given under
Application—21 CFR Part 515—OMB
material on its Web site prior to the the Federal Advisory Committee Act (5
Control Number 0910–0337—Revision
meeting, the background material will U.S.C. app. 2).
be made publicly available at the Dated: June 6, 2016. Feed manufacturers that seek to
location of the advisory committee Jill Hartzler Warner, manufacture feed using Category II,
meeting, and the background material Type A medicated articles or
Associate Commissioner for Special Medical
will be posted on FDA’s Web site after Programs. manufacture certain liquid and free-
the meeting. Background material is choice feed, using Category I, Type A
[FR Doc. 2016–13709 Filed 6–9–16; 8:45 am]
available at http://www.fda.gov/ medicated articles that must follow
BILLING CODE 4164–01–P
AdvisoryCommittees/Calendar/ proprietary formulas or specifications
default.htm. Scroll down to the are required to obtain a facility license
appropriate advisory committee meeting DEPARTMENT OF HEALTH AND under section 512 of the Federal Food,
link. HUMAN SERVICES Drug, and Cosmetic Act (the FD&C Act)
Procedure: Interested persons may (21 U.S.C. 360b). Our regulations in part
present data, information, or views, Food and Drug Administration 515 (21 CFR part 515) establish the
orally or in writing, on issues pending procedures associated with applying for
before the committee. Written [Docket No. FDA–2009–N–0511]
a facility license. We require that a
submissions may be made to the contact manufacturer seeking a facility license
Agency Information Collection
person on or before June 28, 2016. Oral submit a completed medicated feed mill
Activities; Submission for Office of
presentations from the public will be license application using Form FDA
Management and Budget Review;
scheduled between approximately 1:30 3448 (21 CFR 515.10(b)). We use the
Comment Request; Medicated Feed
p.m. and 3 p.m. Those individuals information submitted to establish that
Mill License Application
interested in making formal oral the applicant has made the certifications
presentations should notify the contact AGENCY: Food and Drug Administration, required by section 512 of the FD&C
person and submit a brief statement of HHS. Act, to register the mill, and to schedule
the general nature of the evidence or ACTION: Notice. a pre-approval inspection. We have
arguments they wish to present, the made minor editorial revisions to Form
names and addresses of proposed SUMMARY: The Food and Drug FDA 3448, including the addition of a
participants, and an indication of the Administration (FDA) is announcing dedicated field for the submitter’s email
approximate time requested to make that a proposed collection of address in the contact information
their presentation on or before June 20, information has been submitted to the section. We estimate that the revisions
2016. Time allotted for each Office of Management and Budget will not change the amount of time
presentation may be limited. If the (OMB) for review and clearance under necessary to complete the form.
number of registrants requesting to the Paperwork Reduction Act of 1995.
We require the submission of a
speak is greater than can be reasonably DATES: Fax written comments on the supplemental medicated feed mill
accommodated during the scheduled collection of information by July 11, license application for a change in
open public hearing session, FDA may 2016. facility ownership or a change in facility
conduct a lottery to determine the address (§ 515.11(b)). If a licensed
ADDRESSES: To ensure that comments on
speakers for the scheduled open public facility is no longer manufacturing
the information collection are received,
hearing session. The contact person will medicated animal feed under § 515.23, a
OMB recommends that written
notify interested persons regarding their manufacturer may request voluntary
comments be faxed to the Office of
request to speak by June 21, 2016. revocation of a medicated feed mill
Persons attending FDA’s advisory Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX: license. An applicant also has the right
committee meetings are advised that the
202–395–7285, or emailed to oira_ to file a request for hearing under
Agency is not responsible for providing
submission@omb.eop.gov. All § 515.30(c) to give reasons why a
access to electrical outlets.
comments should be identified with the medicated feed mill license should not
FDA welcomes the attendance of the
OMB control number 0910–0337. Also be refused or revoked.
public at its advisory committee
meetings and will make every effort to include the FDA docket number found In the Federal Register of March 9,
accommodate persons with disabilities. in brackets in the heading of this 2016 (81 FR 12509), FDA published a
If you require accommodations due to a document. 60-day notice requesting public
disability, please contact Moon Hee FOR FURTHER INFORMATION CONTACT: FDA comment on the proposed collection of
Choi at least 7 days in advance of the PRA Staff, Office of Operations, Food information. FDA received one
meeting. and Drug Administration, 8455 comment, which was not responsive to
asabaliauskas on DSK3SPTVN1PROD with NOTICES
FDA is committed to the orderly Colesville Rd., COLE–14526, Silver the comment request.
conduct of its advisory committee Spring, MD 20993–0002, PRAStaff@ We estimate the burden of this
meetings. Please visit our Web site at fda.hhs.gov. collection of information as follows:
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![Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Notices 37603
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden per
21 CFR section and activity responses per Total hours
respondents responses response
respondent
Medicated Feed Mill License Application using 20 1 20 0.25 (15 minutes) ...... 5
Form FDA 3448 (515.10(b)).
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 Li- 40 1 40 0.25 (15 minutes) ...... 10
cense.
(515.23) ....................................................................
Filing a Request for a Hearing on Medicated Feed 1 1 1 4 ................................ 4
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
Number of Total annual Average burden per
21 CFR section and activity records per Total hours
recordkeepers records recordkeeping
recordkeeper
Maintenance of Records for Approved Labeling for 890 1 890 0.03 (2 minutes) ........ 27
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 the docket unchanged. Because your
experience with medicated feed mill Administration (FDA or Agency) is comment will be made public, you are
license applications. We estimate that announcing the availability of the draft solely responsible for ensuring that your
we will receive 20 medicated feed mill guidance entitled ‘‘Dissemination of comment does not include any
license applications, 40 supplemental Patient-Specific Information from confidential information that you or a
applications, 40 requests for voluntary Devices by Device Manufacturers.’’ The third party may not wish to be posted,
revocation, and that these submissions FDA developed this draft guidance to such as medical information, your or
will take approximately 15 minutes per facilitate the appropriate and anyone else’s Social Security number, or
response, as shown in table 1, rows 1 responsible dissemination of patient- confidential business information, such
through 3. We estimate that preparing a specific information recorded, stored, as a manufacturing process. Please note
request for a hearing under § 515.30(c) processed, retrieved, and/or derived that if you include your name, contact
takes approximately 4 hours, as shown from medical devices from information, or other information that
in table 1, row 4. In table 2, we estimate manufacturers to patients. This draft identifies you in the body of your
that 890 licensees will keep the records guidance provides recommendations to comments, that information will be
required by 21 CFR 510.305 expending industry, healthcare providers, and FDA posted on http://www.regulations.gov.
a total of 27 hours annually. staff about the mechanisms and • If you want to submit a comment
Dated: June 6, 2016. considerations for device manufacturers with confidential information that you
Leslie Kux,
sharing such information with patients. do not wish to be made available to the
This draft guidance is not final nor is it public, submit the comment as a
Associate Commissioner for Policy.
in effect at this time. written/paper submission and in the
[FR Doc. 2016–13790 Filed 6–9–16; 8:45 am]
DATES: Although you can comment on manner detailed (see ‘‘Written/Paper
BILLING CODE 4164–01–P
any guidance at any time (see 21 CFR Submissions’’ and ‘‘Instructions’’).
10.115(g)(5)), to ensure that the Agency
considers your comment of this draft Written/Paper Submissions
DEPARTMENT OF HEALTH AND
HUMAN SERVICES guidance before it begins work on the Submit written/paper submissions as
final version of the guidance, submit follows:
Food and Drug Administration either electronic or written comments
on the draft guidance by August 9, 2016. • Mail/Hand delivery/Courier (for
written/paper submissions): Division of
[Docket No. FDA–2016–D–1264] ADDRESSES: You may submit comments
Dockets Management (HFA–305), Food
as follows:
and Drug Administration, 5630 Fishers
Dissemination of Patient-Specific Electronic Submissions Lane, Rm. 1061, Rockville, MD 20852.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Information From Devices by Device
Manufacturers; Draft Guidance for Submit electronic comments in the • For written/paper comments
Industry and Food and Drug following way: submitted to the Division of Dockets
Administration Staff; Availability • Federal eRulemaking Portal: http:// Management, FDA will post your
www.regulations.gov. Follow the comment, as well as any attachments,
AGENCY: Food and Drug Administration, instructions for submitting comments. except for information submitted,
HHS. Comments submitted electronically, marked and identified, as confidential,
including attachments, to http:// if submitted as detailed in
ACTION: Notice of availability.
www.regulations.gov will be posted to ‘‘Instructions.’’
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Document Created: 2018-02-08 07:35:37
Document Modified: 2018-02-08 07:35:37
| 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 | Fax written comments on the collection of information by July 11, 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 37602 |
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