Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Veterinary Feed Directive, 77498-77500 [2014-30157]

Download as PDF 77498 Federal Register / Vol. 79, No. 247 / Wednesday, December 24, 2014 / Notices Dated: December 18, 2014. Martique Jones, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2014–30027 Filed 12–23–14; 8:45 am] Food and Drug Administration [Docket No. FDA–2014–D–1461] Rare Pediatric Disease Priority Review Vouchers; Extension of Comment Period Food and Drug Administration, HHS. Notice of availability; extension of comment period. ACTION: The Food and Drug Administration (FDA) is extending the comment period for the notice of availability (NOA) that appeared in the Federal Register of November 17, 2014. In the NOA, FDA requested comments on the Agency’s implementation of the Rare Pediatric Disease Priority Review Vouchers Program. This action will allow interested persons additional time to submit comments. DATES: FDA is extending the comment period on the NOA published November 17, 2014 (79 FR 68451). Submit either electronic or written comments by February 16, 2015. ADDRESSES: Submit written requests for single copies of the draft guidance to the Office of Communications, Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993–0002; or Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993–0002; or Office of Orphan Products Development, Office of Special Medical Programs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5295, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist the office that will be processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance to https:// www.regulations.gov. Submit written comments to the Division of Dockets mstockstill on DSK4VPTVN1PROD with NOTICES VerDate Sep<11>2014 16:34 Dec 23, 2014 Jkt 235001 Henry Startzman III, Office of Orphan Products Development, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5295, Silver Spring, MD 20993–0002, 301–796–8660. Food and Drug Administration [Docket No. FDA–2010–N–0155] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Veterinary Feed Directive I. Background DEPARTMENT OF HEALTH AND HUMAN SERVICES SUMMARY: FOR FURTHER INFORMATION CONTACT: DEPARTMENT OF HEALTH AND HUMAN SERVICES SUPPLEMENTARY INFORMATION: BILLING CODE 4120–01–P AGENCY: Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. AGENCY: In the Federal Register of November 17, 2014, FDA published a NOA with a 60-day comment period to request comments on FDA’s implementation of the Rare Pediatric Disease Priority Review Vouchers Draft Guidance. Comments on the draft guidance will inform FDA’s drafting of its final guidance for this program. The Agency has recognized a discrepancy between the 90-day comment period included in the draft guidance and the 60-day comment period written in the November 17, 2014, NOA. Thus, it is publishing this NOA to extend the comment period cited in the previous NOA by 30 days. The Agency believes that a 30-day extension allows adequate time for interested persons to submit comments without significantly delaying drafting of the final guidance on these important issues. ACTION: II. Request for Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. Dated: December 18, 2014. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2014–30154 Filed 12–23–14; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00058 Fmt 4703 Food and Drug Administration, HHS. Sfmt 4703 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 January 23, 2015. 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 0910–0363. 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. SUMMARY: Veterinary Feed Directive—21 CFR 558 (OMB Control Number 0910–0363)— (Extension) With the passage of the Animal Drug Availability Act of 1996 (Public Law 104–250), Congress enacted legislation establishing a new class of restricted feed use drugs, VFD drugs, which may be distributed without involving State pharmacy laws. Although controls on the distribution and use of VFD drugs are similar to those for prescription drugs regulated under section 503(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(f)), the implementing VFD regulation (21 CFR 558.6) was tailored to the unique circumstances E:\FR\FM\24DEN1.SGM 24DEN1 77499 Federal Register / Vol. 79, No. 247 / Wednesday, December 24, 2014 / Notices relating to the distribution of medicated feeds. All distributors of medicated feed containing VFD drugs must notify FDA of their intent to distribute such feed, and records must be maintained of the distribution and feeding (under the professional supervision of a licensed veterinarian) of all medicated feeds containing VFD drugs. The VFD regulation ensures the protection of public health while enabling animal producers to obtain and use needed drugs as efficiently and cost-effectively as possible. On December 12, 2013, FDA published a proposed rule in the Federal Register (78 FR 75515), intended to improve the efficiency of FDA’s VFD program. The provisions included in the proposed rule were based on stakeholder input received in response to solicitations for public comment, including an advance notice of proposed rulemaking on March 29, 2010 (75 FR 15387), and draft text of proposed amendments to the current VFD regulations on April 13, 2012 (77 FR 22247). In the Federal Register of September 25, 2014 (79 FR 57558), FDA published a 60-day notice requesting public comment on the proposed collection of information. One comment was received but it did not respond to any of the four collection of information topics solicited in the notice and therefore is not discussed in this document. At the same time, since publication of the 60day notice, the burden for this information collection has been revised to reflect an update in the number of veterinarians, producers, and distributors, as well as updated cost burden information. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of responses per respondent Number of respondents 21 CFR section Average burden per response Total annual responses Total hours 558.6(d)(1)(i) through (d)(1)(iii): A distributor must notify FDA prior to the first time it distributes a VFD drug. 558.6(d)(1)(iv): A distributor must notify FDA within 30 days of any change in ownership, business name, or business address. 514.1(b)(9): Sponsor submits 3 copies of VFD with new drug application. 300 1 300 .25 (15 minutes) ........... 75 20 1 20 .25 (15 minutes) ........... 5 1 1 1 3 .................................... 3 Total ............................................................... ........................ ........................ ........................ ....................................... 83 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 recordkeepers 21 CFR section Number of records per recordkeeper Average burden per recordkeeping Total annual records Total hours 558.6(c)(1) through (c)(4): Filing of VFD copies by veterinarians and producers 2. 558.6(e)(1) through (e)(4): Filing of VFD copies by distributors only 3. 13,050 114.9 1,500,000 .0167 (1 minute) ........... 25,050 1,376 545.1 750,000 .0167 (1 minute) ........... 12,525 Total ............................................................... 14,426 ........................ 2,250,000 ....................................... 37,575 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 The same recordkeeping requirement for distributors is listed in two separate sections of the codified; therefore, we have listed distributors separately (in reference to 558.6(e)(1) through (e)(4)) in order to avoid double counting their recordkeeping requirement. 3 Distributors may receive an acknowledgement letter in lieu of a VFD when consigning VFD feed to another distributor (please see table 3.). Such letters, like VFDs, are also subject to a 2-year record retention requirement. Thus, the recordkeeping burden for acknowledgement letters is included as a subset of the VFD recordkeeping burden. TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE 1 Number of respondents 21 CFR section Number of disclosures per respondent Average burden per disclosure Total annual disclosures Total hours mstockstill on DSK4VPTVN1PROD with NOTICES 558.6(a)(3) through (a)(5): Veterinarian issues VFD. 558.6(d)(2): Acknowledgement letter generation 2 3,050 246 750,000 0.125 (7 minutes) ......... 93,750 2 1,000 5 5,000 0.125 (7 minutes) ......... 625 Total ............................................................... ........................ ........................ ........................ ....................................... 94,375 1 There are no capital costs or operating and maintenance costs associated with this collection of information. VFD distributors (of the 1,376 total distributors) multiplied by 5 disclosures per distributor equals 5,000 annual acknowledgement letters, multiplied by 0.125 hours equals 625 hours annually. 2 1,000 The estimate of time required for record preparation and maintenance is VerDate Sep<11>2014 16:34 Dec 23, 2014 Jkt 235001 based on Agency communication with PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 industry and Agency records and experience. E:\FR\FM\24DEN1.SGM 24DEN1 77500 Federal Register / Vol. 79, No. 247 / Wednesday, December 24, 2014 / Notices Dated: December 18, 2014. Leslie Kux, Associate Commissioner for Policy. FOR FURTHER INFORMATION CONTACT: Luciana Borio, Assistant Commissioner for Counterterrorism Policy, Office of Counterterrorism and Emerging Threats, and Acting Deputy Chief Scientist, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4340, Silver Spring, MD 20993–0002, 301– 796–8510 (this is not a toll free number). SUPPLEMENTARY INFORMATION: [FR Doc. 2014–30157 Filed 12–23–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration I. Background [Docket No. FDA–2014–N–2104] Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Ebola Zaire Virus; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the issuance of two Emergency Use Authorizations (EUAs) (the Authorizations) for two in vitro diagnostic devices for detection of the Ebola Zaire virus. FDA is issuing these Authorizations under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by the Centers for Disease Control and Prevention (CDC). The Authorizations contain, among other things, conditions on the emergency use of the authorized in vitro diagnostic devices. The Authorizations follow the September 22, 2006, determination by then-Secretary of the Department of Homeland Security (DHS), Michael Chertoff, that the Ebola virus presents a material threat against the U.S. population sufficient to affect national security. On the basis of such determination, the Secretary of Health and Human Services (HHS) declared on August 5, 2014, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of Ebola virus subject to the terms of any authorization issued under the FD&C Act. The Authorizations, which include an explanation of the reasons for issuance, are reprinted in this document. DATES: The Authorizations are effective as of October 10, 2014. ADDRESSES: Submit written requests for single copies of the EUAs to the Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the Authorizations may be sent. See the SUPPLEMENTARY INFORMATION section for electronic access to the Authorizations. mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:34 Dec 23, 2014 Jkt 235001 Section 564 of the FD&C Act (21 U.S.C. 360bbb–3) as amended by the Project BioShield Act of 2004 (Pub. L. 108–276) and the Pandemic and AllHazards Preparedness Reauthorization Act of 2013 (Pub. L. 113–5) allows FDA to strengthen the public health protections against biological, chemical, nuclear, and radiological agents. Among other things, section 564 of the FD&C Act allows FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product in certain situations. With this EUA authority, FDA can help assure that medical countermeasures may be used in emergencies to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by biological, chemical, nuclear, or radiological agents when there are no adequate, approved, and available alternatives. Section 564(b)(1) of the FD&C Act provides that, before an EUA may be issued, the Secretary of HHS must declare that circumstances exist justifying the authorization based on one of the following grounds: (1) A determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a biological, chemical, radiological, or nuclear agent or agents; (2) a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to U.S. military forces of attack with a biological, chemical, radiological, or nuclear agent or agents; (3) a determination by the Secretary of HHS that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of U.S. citizens living abroad, and that involves a biological, chemical, radiological, or nuclear agent or agents, or a disease or condition that may be attributable to such agent or agents; or (4) the identification of a material threat by the Secretary of Homeland Security PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 under section 319F–2 of the Public Health Service (PHS) Act (42 U.S.C. 247d–6b) sufficient to affect national security or the health and security of U.S. citizens living abroad. Once the Secretary of HHS has declared that circumstances exist justifying an authorization under section 564 of the FD&C Act, FDA may authorize the emergency use of a drug, device, or biological product if the Agency concludes that the statutory criteria are satisfied. Under section 564(h)(1) of the FD&C Act, FDA is required to publish in the Federal Register a notice of each authorization, and each termination or revocation of an authorization, and an explanation of the reasons for the action. Section 564 of the FD&C Act permits FDA to authorize the introduction into interstate commerce of a drug, device, or biological product intended for use when the Secretary of HHS has declared that circumstances exist justifying the authorization of emergency use. Products appropriate for emergency use may include products and uses that are not approved, cleared, or licensed under sections 505, 510(k), or 515 of the FD&C Act (21 U.S.C. 355, 360(k), and 360e) or section 351 of the PHS Act (42 U.S.C. 262). FDA may issue an EUA only if, after consultation with the HHS Assistant Secretary for Preparedness and Response, the Director of the National Institutes of Health, and the Director of the CDC (to the extent feasible and appropriate given the applicable circumstances), FDA 1 concludes: (1) That an agent referred to in a declaration of emergency or threat can cause a serious or lifethreatening disease or condition; (2) that, based on the totality of scientific evidence available to FDA, including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that: (A) The product may be effective in diagnosing, treating, or preventing (i) such disease or condition; or (ii) a serious or lifethreatening disease or condition caused by a product authorized under section 564, approved or cleared under the FD&C Act, or licensed under section 351 of the PHS Act, for diagnosing, treating, or preventing such a disease or condition caused by such an agent; and (B) the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product, taking into consideration the material threat posed by the agent or agents identified 1 The Secretary of HHS has delegated the authority to issue an EUA under section 564 of the FD&C Act to the Commissioner of Food and Drugs. E:\FR\FM\24DEN1.SGM 24DEN1

Agencies

[Federal Register Volume 79, Number 247 (Wednesday, December 24, 2014)]
[Notices]
[Pages 77498-77500]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-30157]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0155]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Veterinary Feed
Directive

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 January
23, 2015.

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 0910-0363.
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.

Veterinary Feed Directive--21 CFR 558 (OMB Control Number 0910-0363)--
(Extension)

With the passage of the Animal Drug Availability Act of 1996
(Public Law 104-250), Congress enacted legislation establishing a new
class of restricted feed use drugs, VFD drugs, which may be distributed
without involving State pharmacy laws. Although controls on the
distribution and use of VFD drugs are similar to those for prescription
drugs regulated under section 503(f) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 353(f)), the implementing VFD regulation (21
CFR 558.6) was tailored to the unique circumstances

[[Page 77499]]

relating to the distribution of medicated feeds. All distributors of
medicated feed containing VFD drugs must notify FDA of their intent to
distribute such feed, and records must be maintained of the
distribution and feeding (under the professional supervision of a
licensed veterinarian) of all medicated feeds containing VFD drugs. The
VFD regulation ensures the protection of public health while enabling
animal producers to obtain and use needed drugs as efficiently and
cost-effectively as possible.
On December 12, 2013, FDA published a proposed rule in the Federal
Register (78 FR 75515), intended to improve the efficiency of FDA's VFD
program. The provisions included in the proposed rule were based on
stakeholder input received in response to solicitations for public
comment, including an advance notice of proposed rulemaking on March
29, 2010 (75 FR 15387), and draft text of proposed amendments to the
current VFD regulations on April 13, 2012 (77 FR 22247).
In the Federal Register of September 25, 2014 (79 FR 57558), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received but it did not
respond to any of the four collection of information topics solicited
in the notice and therefore is not discussed in this document. At the
same time, since publication of the 60-day notice, the burden for this
information collection has been revised to reflect an update in the
number of veterinarians, producers, and distributors, as well as
updated cost burden information.
FDA estimates the burden of this collection of information as
follows:

Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
558.6(d)(1)(i) through 300 1 300 .25 (15 minutes) 75
(d)(1)(iii): A distributor
must notify FDA prior to the
first time it distributes a
VFD drug.
558.6(d)(1)(iv): A distributor 20 1 20 .25 (15 minutes) 5
must notify FDA within 30
days of any change in
ownership, business name, or
business address.
514.1(b)(9): Sponsor submits 3 1 1 1 3............... 3
copies of VFD with new drug
application.
---------------------------------------------------------------------------------
Total..................... .............. .............. .............. ................ 83
----------------------------------------------------------------------------------------------------------------
\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 burden
21 CFR section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
558.6(c)(1) through (c)(4): 13,050 114.9 1,500,000 .0167 (1 minute) 25,050
Filing of VFD copies by
veterinarians and producers
\2\.
558.6(e)(1) through (e)(4): 1,376 545.1 750,000 .0167 (1 minute) 12,525
Filing of VFD copies by
distributors only \3\.
---------------------------------------------------------------------------------
Total..................... 14,426 .............. 2,250,000 ................ 37,575
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ The same recordkeeping requirement for distributors is listed in two separate sections of the codified;
therefore, we have listed distributors separately (in reference to 558.6(e)(1) through (e)(4)) in order to
avoid double counting their recordkeeping requirement.
\3\ Distributors may receive an acknowledgement letter in lieu of a VFD when consigning VFD feed to another
distributor (please see table 3.). Such letters, like VFDs, are also subject to a 2-year record retention
requirement. Thus, the recordkeeping burden for acknowledgement letters is included as a subset of the VFD
recordkeeping burden.

Table 3--Estimated Annual Third-Party Disclosure \1\
----------------------------------------------------------------------------------------------------------------
Number of
Number of disclosures Total annual Average burden
21 CFR section respondents per disclosures per disclosure Total hours
respondent
----------------------------------------------------------------------------------------------------------------
558.6(a)(3) through (a)(5): 3,050 246 750,000 0.125 (7 93,750
Veterinarian issues VFD. minutes).
558.6(d)(2): Acknowledgement \2\ 1,000 5 5,000 0.125 (7 625
letter generation \2\. minutes).
---------------------------------------------------------------------------------
Total..................... .............. .............. .............. ................ 94,375
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ 1,000 VFD distributors (of the 1,376 total distributors) multiplied by 5 disclosures per distributor equals
5,000 annual acknowledgement letters, multiplied by 0.125 hours equals 625 hours annually.

The estimate of time required for record preparation and
maintenance is based on Agency communication with industry and Agency
records and experience.

[[Page 77500]]

Dated: December 18, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-30157 Filed 12-23-14; 8:45 am]
BILLING CODE 4164-01-P

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