81 FR 71506 - Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Drug User Fee Act Waivers and Reductions
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 200 (October 17, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 200 (October 17, 2016)
| Page Range | 71506-71508 | |
| FR Document | 2016-25040 |
[Federal Register Volume 81, Number 200 (Monday, October 17, 2016)] [Notices] [Pages 71506-71508] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-25040] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-N-0037] Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Drug User Fee Act Waivers and Reductions AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the paperwork burden of requesting a waiver or reduction of fees under Animal Drug User Fee Act (ADUFA). [[Page 71507]] DATES: Submit either electronic or written comments on the collection of information by December 16, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2007-N-0037 for ``Animal Drug User Fee Act Waivers and Reductions.'' 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, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Animal Drug User Fees and Fee Waivers and Reductions OMB Control Number 0910-0540--Extension Enacted on November 18, 2003, the Animal Drug User Fee Act (Pub. L. 108-130) amended the Federal Food, Drug, and Cosmetic Act and requires FDA to assess and collect user fees for certain applications, products, establishments, and sponsors. It also requires the Agency to grant a waiver from, or a reduction of those fees in certain circumstances. Thus, to implement this statutory provision of ADUFA, FDA developed a guidance entitled ``Guidance for Industry: Animal Drug User Fees and Fee Waivers and Reductions.'' This document provides guidance on the types of fees FDA is authorized to collect under ADUFA, and how to request waivers and reductions from FDA's animal drug user fees. Further, this guidance also describes the types of fees and fee waivers and reductions; what information FDA recommends be submitted in support of a request for a fee waiver or reduction; how to submit such a request; and FDA's process for reviewing requests. Respondents to this collection of information are new animal drug sponsors. Requests for waivers or reductions may be submitted by a person paying any of the animal drug user fees assessed, including application fees, product fees, establishment fees, or sponsor fees. FDA estimates the burden for this collection of information as follows: [[Page 71508]] Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Number of responses per Total annual 21 CFR section; activity respondents respondent responses Average burden per response Total hours -------------------------------------------------------------------------------------------------------------------------------------------------------- 740(d)(1)(A); significant barrier to 55 1 time for each 55 2................................. 110 innovation. application. 740(d)(1)(B); fees exceed cost.......... 8 3.75...................... 30 0.5 (30 minutes).................. 15 740(d)(1)(C); free choice feeds......... 5 1 time for each 5 2................................. 10 application. 740(d)(1)(D); minor use or minor species 69 1 time for each 69 2................................. 138 application. 740(d)(1)(E); small business............ 1 1 time for each 1 2................................. 2 application. Request for reconsideration of a 1 1 time for each 1 2................................. 2 decision. application. Request for review (user fee appeal 0 1 time for each 0 0................................. 0 officer). application. --------------------------------------------------------------------------------------------------------------- Total............................... .............. .......................... .............. .................................. 277 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Based on FDA's database system, from fiscal year (FY) 2014 to 2016 there were an estimated 177 sponsors subject to ADUFA. However, not all sponsors will have any submissions in a given year and some may have multiple submissions. The total number of waiver requests is based on the average number of submission types received by FDA in FY 2014 to 2016. Dated: October 12, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-25040 Filed 10-14-16; 8:45 am] BILLING CODE 4164-01-P
![71506 Federal Register / Vol. 81, No. 200 / Monday, October 17, 2016 / Notices
pregnancy with the index child, (2) developmental evaluation, (4) maternal There are no costs to participants
parent-completed questionnaires about and child anthropometry measurements, other than their time. The total
parental and child health and child and (5) biosampling from biological estimated annual burden hours are
development, (3) in-person child parents and child. 7,118.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number
Number of burden per
Type of respondents Form name responses per
respondents response
respondent (in hours)
Mother All potential participants sent mailing ............... Invitation Packet/Response Card .... 1,718 1 10/60
Mother Potentially eligible with contact by study staff .. Invitation Call Script and Social 859 1 30/60
Communication Questionnaire.
Mother Eligible, consented, and enrolled; assigned to Enrollment Packet ............................ 469 1 20/60
the ASD workflow based on enrollment intake.
Mother Completed this study step ................................ Follow-up Phone Call Script and 422 1 15/60
Pregnancy Reference Form.
Maternal Interview Call .................... 422 1 1
Self-Administered Forms ................. 375 1 105/60
Follow-up Call 2 ............................... 375 1 20/60
Clinic/Home Visit—Developmental 328 1 225/60
Assessment.
Father Completed this study step ................................. Clinic/Home Visit—Saliva Collection 164 1 15/60
(optional—on own).
Child Completed this study step ................................... Clinic/Home Visit—Developmental 328 1 135/60
Assessment.
Mother All potential participants sent mailing ............... Invitation Packet/Response Card .... 1,466 1 10/60
Mother Potentially eligible with contact by study staff .. Invitation Call Script and Social 733 1 30/60
Communication Questionnaire.
Mother Eligible, consented, and enrolled; assigned to Enrollment Packet ............................ 334 1 20/60
the POP workflow based on enrollment intake.
Mother Completed this study step ................................ Follow-up Phone Call Script and 301 1 15/60
Pregnancy Reference Form.
Maternal Interview Call .................... 301 1 1
Self-Administered Forms ................. 267 1 105/60
Follow-up Call 2 ............................... 267 1 20/60
Clinic/Home Visit—Developmental 234 1 50/60
Assessment.
Father Completed this study step ................................. Clinic/Home Visit—Saliva Collection 117 1 15/60
(optional—on own).
Child Completed this study step ................................... Clinic/Home Visit—Developmental 234 1 90/60
Assessment.
Mother All potential participants sent mailing ............... Invitation Packet/Response Card .... 641 1 10/60
Mother Potentially eligible with contact by study staff .. Invitation Call Script and Social 321 1 30/60
Communication Questionnaire.
Mother Eligible, consented, and enrolled; assigned to Enrollment Packet ............................ 175 1 20/60
the DD workflow based on enrollment intake.
Mother Completed this study step ................................ Follow-up Phone Call Script and 158 1 15/60
Pregnancy Reference Form.
Maternal Interview Call .................... 158 1 1
Self-Administered Forms ................. 140 1 55/60
Follow-up Call 2 ............................... 140 1 20/60
Leroy A. Richardson, DEPARTMENT OF HEALTH AND opportunity for public comment on the
Chief, Information Collection Review Office, HUMAN SERVICES proposed collection of certain
Office of Scientific Integrity, Office of the information by the Agency. Under the
Associate Director for Science, Office of the Food and Drug Administration Paperwork Reduction Act of 1995 (the
Director, Centers for Disease Control and PRA), Federal Agencies are required to
Prevention. [Docket No. FDA–2007–N–0037] publish notice in the Federal Register
[FR Doc. 2016–25061 Filed 10–14–16; 8:45 am] concerning each proposed collection of
Agency Information Collection
BILLING CODE 4163–18–P
Activities; Proposed Collection; information, including each proposed
Comment Request; Animal Drug User extension of an existing collection of
jstallworth on DSK7TPTVN1PROD with NOTICES
Fee Act Waivers and Reductions information, and to allow 60 days for
public comment in response to the
AGENCY: Food and Drug Administration, notice. This notice solicits comments on
HHS. the paperwork burden of requesting a
ACTION: Notice. waiver or reduction of fees under
Animal Drug User Fee Act (ADUFA).
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
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![71508 Federal Register / Vol. 81, No. 200 / Monday, October 17, 2016 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Total Average
Number of Total
21 CFR section; activity responses per annual burden per
respondents hours
respondent responses response
740(d)(1)(A); significant barrier to innova- 55 1 time for each application 55 2 ............................ 110
tion.
740(d)(1)(B); fees exceed cost ................ 8 3.75 .................................... 30 0.5 (30 minutes) .... 15
740(d)(1)(C); free choice feeds ................ 5 1 time for each application 5 2 ............................ 10
740(d)(1)(D); minor use or minor species 69 1 time for each application 69 2 ............................ 138
740(d)(1)(E); small business .................... 1 1 time for each application 1 2 ............................ 2
Request for reconsideration of a decision 1 1 time for each application 1 2 ............................ 2
Request for review (user fee appeal offi- 0 1 time for each application 0 0 ............................ 0
cer).
Total .................................................. ........................ ............................................ ........................ ............................... 277
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on FDA’s database system, from DATES: Submit either electronic or except for information submitted,
fiscal year (FY) 2014 to 2016 there were written comments on the collection of marked and identified, as confidential,
an estimated 177 sponsors subject to information by December 16, 2016. if submitted as detailed in
ADUFA. However, not all sponsors will ADDRESSES: You may submit comments ‘‘Instructions.’’
have any submissions in a given year as follows: Instructions: All submissions received
and some may have multiple must include the Docket No. FDA–
submissions. The total number of Electronic Submissions 2010–N–0601 for ‘‘Agency Information
waiver requests is based on the average Submit electronic comments in the Collection Activities; Proposed
number of submission types received by following way: Collection; Comment Request; Current
FDA in FY 2014 to 2016. • Federal eRulemaking Portal: http:// Good Manufacturing Practice
www.regulations.gov. Follow the Regulations for Medicated Feeds.’’
Dated: October 12, 2016.
instructions for submitting comments. Received comments will be placed in
Leslie Kux,
Comments submitted electronically, the docket and, except for those
Associate Commissioner for Policy. submitted as ‘‘Confidential
including attachments, to http://
[FR Doc. 2016–25040 Filed 10–14–16; 8:45 am] Submissions,’’ publicly viewable at
www.regulations.gov will be posted to
BILLING CODE 4164–01–P
the docket unchanged. Because your http://www.regulations.gov or at the
comment will be made public, you are Division of Dockets Management
solely responsible for ensuring that your between 9 a.m. and 4 p.m., Monday
DEPARTMENT OF HEALTH AND through Friday.
comment does not include any
HUMAN SERVICES • Confidential Submissions—To
confidential information that you or a
third party may not wish to be posted, submit a comment with confidential
Food and Drug Administration
such as medical information, your or information that you do not wish to be
[Docket No. FDA–2010–N–0601] anyone else’s Social Security number, or made publicly available, submit your
confidential business information, such comments only as a written/paper
Agency Information Collection submission. You should submit two
as a manufacturing process. Please note
Activities; Proposed Collection; copies total. One copy will include the
that if you include your name, contact
Comment Request; Current Good information you claim to be confidential
information, or other information that
Manufacturing Practice Regulations for with a heading or cover note that states
identifies you in the body of your
Medicated Feeds ‘‘THIS DOCUMENT CONTAINS
comments, that information will be
AGENCY: Food and Drug Administration, posted on http://www.regulations.gov. CONFIDENTIAL INFORMATION.’’ The
HHS. • If you want to submit a comment Agency will review this copy, including
ACTION: Notice. with confidential information that you the claimed confidential information, in
do not wish to be made available to the its consideration of comments. The
SUMMARY: The Food and Drug public, submit the comment as a second copy, which will have the
Administration (FDA) is announcing an written/paper submission and in the claimed confidential information
opportunity for public comment on the manner detailed (see ‘‘Written/Paper redacted/blacked out, will be available
proposed collection of certain Submissions’’ and ‘‘Instructions’’). for public viewing and posted on http://
information by the Agency. Under the www.regulations.gov. Submit both
Paperwork Reduction Act of 1995 (the Written/Paper Submissions copies to the Division of Dockets
PRA), Federal Agencies are required to Submit written/paper submissions as Management. If you do not wish your
publish notice in the Federal Register follows: name and contact information to be
concerning each proposed collection of • Mail/Hand delivery/Courier (for made publicly available, you can
information, including each proposed written/paper submissions): Division of provide this information on the cover
jstallworth on DSK7TPTVN1PROD with NOTICES
extension of an existing collection of Dockets Management (HFA–305), Food sheet and not in the body of your
information, and to allow 60 days for and Drug Administration, 5630 Fishers comments and you must identify this
public comment in response to the Lane, Rm. 1061, Rockville, MD 20852. information as ‘‘confidential.’’ Any
notice. This notice solicits comments on • For written/paper comments information marked as ‘‘confidential’’
the recordkeeping requirements for submitted to the Division of Dockets will not be disclosed except in
manufacturers of medicated animal Management, FDA will post your accordance with 21 CFR 10.20 and other
feeds. comment, as well as any attachments, applicable disclosure law. For more
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Document Created: 2016-10-15 01:51:33
Document Modified: 2016-10-15 01:51:33
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit either electronic or written comments on the collection of information by December 16, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected] | |
| FR Citation | 81 FR 71506 |
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