Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Practices and Procedures; Formal Evidentiary Public Hearing, 73320-73322 [2014-28825]

Download as PDF 73320 Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Notices respondents’ current location and follow-up with respondents in the future. The Head Start Impact Study is a longitudinal study involving 4,667 firsttime enrolled three- and four-year-old preschool children across 84 nationally representative grantee/delegate agencies (in communities where there were more eligible children and families than can be served by the program). Participants were randomly assigned to either a Head Start group (that could enroll in Head Start services) or a control group (that could not enroll in Head services) or a control group (that could not enroll in Head Start services but could enroll in other available services selected by their parents). Data collection for the study began in fall of 2002 and has continued through late spring 2008 to include the participants’ 3rd grade year. Location and contact information for participants has continued every spring beginning in 2009 and continued through spring 2014. ACF will continue to collect a small amount of information for the sample through the spring of the participant’s 12th grade year. To maintain adequate sample size, telephone interviews (with in-person follow-up as necessary) will be conducted in order to update the children’s status and their location and contact information. Additionally, the parent interview will include a small set of items on children’s special education needs, grade retention, school safety, school engagement, and parental monitoring to provide information on factors during adolescence that may influence long-term impacts of Head Start examined in a potential follow-up study. This information will be collected from parents or guardians in the spring of 2015 and 2016. Updates will take about 20 minutes to complete. Respondents: The original sample of 4,667 treatment and control group members in the Head Start Impact Study, less 432 families that have given a ‘‘hard’’ refusal to participate in the study (e.g., refused to participate if they were contacted again). The number of respondents for this requested data collection is 4,235. ANNUAL BURDEN ESTIMATES Instrument Total number of respondents Annual number of respondents Number of responses per respondent Average burden hours per response Annual burden hours Parent Interview ................................................................... 8470 4235 1 1/3 1412 mstockstill on DSK4VPTVN1PROD with NOTICES Estimated Total Annual Burden Hours: 1412. Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L’Enfant Promenade SW., Washington, DC 20447, Attn: OPRE Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: OPREinfocollection@acf.hhs.gov. OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Email: OIRA_ SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the Administration, for Children and Families. Naomi Goldstein, Director, Office of Planning, Research and Evaluation; Administration for Children and Families. [FR Doc. 2014–28843 Filed 12–9–14; 8:45 am] BILLING CODE 4184–22–P VerDate Sep<11>2014 17:48 Dec 09, 2014 Jkt 235001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–2029] Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Practices and Procedures; Formal Evidentiary Public Hearing AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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 reporting requirements contained in current FDA regulations: Administrative Practices and Procedures; Formal Evidentiary Public Hearing. DATES: Submit either electronic or written comments on the collection of information by February 9, 2015. ADDRESSES: Submit electronic comments on the collection of information to https:// SUMMARY: PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. 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: 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. SUPPLEMENTARY INFORMATION: E:\FR\FM\10DEN1.SGM 10DEN1 Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Notices mstockstill on DSK4VPTVN1PROD with NOTICES 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. Administrative Practices and Procedures (21 CFR 10.30, 10.33, 10.35, 10.85); Formal Evidentiary Public Hearing (21 CFR 12.22, 12.45) (OMB Control Number 0910–0191)—Extension The Administrative Procedures Act (5 U.S.C. 553(e)) provides that every Agency shall give an interested person the right to petition for issuance, amendment, or repeal of a rule. Section 10.30 (21 CFR 10.30) sets forth the format and procedures by which an interested person may submit to FDA, in accordance with § 10.20 (21 CFR 10.20) (Submission of documents to Division of Dockets Management), a citizen petition requesting the Commissioner to issue, amend, or revoke a regulation or order, or to take or refrain from taking any other form of administrative action. The Commissioner may grant or deny such a petition, in whole or in part, and may grant such other relief or take other action as the petition warrants. Respondents are individuals or households, State or local governments, and not-for profit institutions or groups. Section 10.33 (21 CFR 10.33), issued under section 701(a) of the Federal, Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 371(a)), sets forth the format and procedures by which an interested person may request reconsideration of part or all of a decision of the Commissioner on a petition submitted under 21 CFR 10.25 (Initiation of administrative proceedings). A petition for reconsideration must contain a full statement in a well-organized format of the factual and legal grounds upon which the petition relies. The grounds must demonstrate that relevant information and views contained in the administrative record were not previously or not adequately considered by the Commissioner. The respondent must submit a petition no later than 30 VerDate Sep<11>2014 17:48 Dec 09, 2014 Jkt 235001 days after the decision involved. However, the Commissioner may, for good cause, permit a petition to be filed after 30 days. An interested person who wishes to rely on information or views not included in the administrative record shall submit them with a new petition to modify the decision. FDA uses the information provided in the request to determine whether to grant the petition for reconsideration. Respondents to this collection of information are individuals of households, State or local governments, not-for-profit institutions, and businesses or other for-profit institutions who are requesting from the Commissioner of FDA a reconsideration of a matter. Section 10.35 (21 CFR 10.35), issued under section 701(a) of the FD&C Act, sets forth the format and procedures by which an interested person may request, in accordance with § 10.20 (Submission of documents to Division of Dockets Management), the Commissioner to stay the effective date of any administrative action. Such a petition must do the following: (1) Identify the decision involved; (2) state the action requested, including the length of time for which a stay is requested; and (3) include a statement of the factual and legal grounds on which the interested person relies in seeking the stay. FDA uses the information provided in the request to determine whether to grant the petition for stay of action. Respondents to this information collection are interested persons who choose to file a petition for an administrative stay of action. Section 10.85 (21 CFR 10.85), issued under section 701(a) of the FD&C Act, sets forth the format and procedures by which an interested person may request, in accordance with § 10.20 (Submission of documents to Division of Dockets Management), an advisory opinion from the Commissioner on a matter of general applicability. An advisory opinion represents the formal position of FDA on a matter of general applicability. When making a request, the petitioner must provide a concise statement of the issues and questions on which an opinion is requested, and a full statement of the facts and legal points relevant to the request. Respondents to this collection of information are interested persons seeking an advisory opinion from the Commissioner on the Agency’s formal position for matters of general applicability. FDA has developed a method for electronic submission of citizen petitions. The Agency still allows for non-electronic submissions; however, PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 73321 electronic submissions of a citizen petition to a specific electronic docket presents a simpler and more straightforward approach. FDA has created a single docket on https:// www.regulations.gov, the U.S. Government’s consolidated docket Web site for Federal Agencies, for the initial electronic submission of all citizen petitions. The advantage to this change is that it ensures efficiency and ease in communication, quicker interaction between citizen petitioners and FDA, and easier access to FDA to seek input through the citizen petition process. The regulations in 21 CFR 12.22, issued under section 701(e)(2) of the FD&C Act (21 U.S.C. 371(e)(2)), set forth the instructions for filing objections and requests for a hearing on a regulation or order under § 12.20(d) (21 CFR 12.20(d)). Objections and requests must be submitted within the time specified in § 12.20(e). Each objection, for which a hearing has been requested, must be separately numbered and specify the provision of the regulation or the proposed order. In addition, each objection must include a detailed description and analysis of the factual information and any other document, with some exceptions, supporting the objection. Failure to include this information constitutes a waiver of the right to a hearing on that objection. FDA uses the description and analysis to determine whether a hearing request is justified. The description and analysis may be used only for the purpose of determining whether a hearing has been justified under 21 CFR 12.24 and does not limit the evidence that may be presented if a hearing is granted. Respondents to this information collection are those parties that may be adversely affected by an order or regulation. Section 12.45 (21 CFR 12.45) issued under section 701 of the FD&C Act (21 U.S.C. 371), sets forth the format and procedures for any interested person to file a petition to participate in a formal evidentiary hearing, either personally or through a representative. Section 12.45 requires that any person filing a notice of participation state their specific interest in the proceedings, including the specific issues of fact about which the person desires to be heard. This section also requires that the notice include a statement that the person will present testimony at the hearing and will comply with specific requirements in 21 CFR 12.85, or, in the case of a hearing before a Public Board of Inquiry, concerning disclosure of data and information by participants (21 CFR 13.25). In accordance with § 12.45(e) the E:\FR\FM\10DEN1.SGM 10DEN1 73322 Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Notices presiding officer may omit a participant’s appearance. The presiding officer and other participants will use the collected information in a hearing to identify specific interests to be presented. This preliminary information serves to expedite the prehearing conference and commits participation. The respondents are individuals or households, State or local governments, not-for-profit institutions and businesses, or other for-profit groups and institutions. 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 10.30—Citizen Petition ........................................................ 10.33—Administrative reconsideration of action ................. 10.35—Administrative Stay of Action .................................. 10.85—Advisory Opinions ................................................... 12.22—Filing Objections and Requests for a Hearing on a Regulation or Order .......................................................... 12.45—Notice of Participation ............................................. Average burden per response Total annual responses 207 4 5 4 1 1 1 1 207 4 5 4 24 10 10 16 4,968 40 50 64 3 4 1 1 3 4 20 3 60 12 Total .............................................................................. 1 There Dated: December 4, 2014. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2014–28825 Filed 12–9–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–D–1067] Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products—Content and Format; Guidance for Industry; Availability Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) is announcing the availability of a guidance for industry entitled ‘‘Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products—Content and Format.’’ The recommendations in this guidance are intended to assist applicants in developing the ‘‘Patient Counseling Information’’ section of labeling and to help ensure that this section of labeling is clear, useful, informative, and to the extent possible, consistent in content and format. This guidance finalizes the draft guidance issued on September 18, 2013. SUMMARY: mstockstill on DSK4VPTVN1PROD with NOTICES 5,194 are no capital costs or operating and maintenance costs associated with this collection of information. The burden estimates for this collection of information are based on Agency records and experience over the past 3 years. AGENCY: Total hours VerDate Sep<11>2014 17:48 Dec 09, 2014 Jkt 235001 Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993, or the 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. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Jonas Santiago, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6348, Silver Spring, MD 20993–0002, 301– 796–5346; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240–402–7911. SUPPLEMENTARY INFORMATION: DATES: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Patient PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 Counseling Information Section of Labeling for Human Prescription Drug and Biological Products—Content and Format.’’ This guidance is intended to assist applicants in developing the Patient Counseling Information section of labeling required under 21 CFR 201.57(c)(18). Recommendations include the following: (1) How to decide what topics to include in the section, (2) how to present information within the section, and (3) how to format and organize section contents. This guidance is one of a series of guidances FDA is developing, or has developed, to assist applicants with the content and format of labeling for human prescription drug and biological products. In the Federal Register of January 24, 2006 (71 FR 3922), FDA published a final rule on labeling for human prescription drug and biological products. The final rule and additional guidances can be accessed at https:// www.fda.gov/Drugs/ GuidanceCompliance RegulatoryInformation/ LawsActsandRules/ucm084159.htm. The labeling requirements and these guidances are intended to make information in prescription drug labeling easier for health care practitioners to access, read, and use. This guidance finalizes the draft guidance issued on September 18, 2013 (78 FR 57394). FDA reviewed all received comments carefully during the finalization of the guidance. Other than clarifying edits, no changes of significance were made to the final version of the guidance. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency’s E:\FR\FM\10DEN1.SGM 10DEN1

Agencies

[Federal Register Volume 79, Number 237 (Wednesday, December 10, 2014)]
[Notices]
[Pages 73320-73322]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-28825]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-2029]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Administrative Practices and Procedures; Formal 
Evidentiary Public Hearing

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 reporting requirements 
contained in current FDA regulations: Administrative Practices and 
Procedures; Formal Evidentiary Public Hearing.

DATES: Submit either electronic or written comments on the collection 
of information by February 9, 2015.

ADDRESSES: Submit electronic comments on the collection of information 
to https://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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: 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.

[[Page 73321]]

    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.
Administrative Practices and Procedures (21 CFR 10.30, 10.33, 10.35, 
10.85); Formal Evidentiary Public Hearing (21 CFR 12.22, 12.45) (OMB 
Control Number 0910-0191)--Extension
    The Administrative Procedures Act (5 U.S.C. 553(e)) provides that 
every Agency shall give an interested person the right to petition for 
issuance, amendment, or repeal of a rule. Section 10.30 (21 CFR 10.30) 
sets forth the format and procedures by which an interested person may 
submit to FDA, in accordance with Sec.  10.20 (21 CFR 10.20) 
(Submission of documents to Division of Dockets Management), a citizen 
petition requesting the Commissioner to issue, amend, or revoke a 
regulation or order, or to take or refrain from taking any other form 
of administrative action.
    The Commissioner may grant or deny such a petition, in whole or in 
part, and may grant such other relief or take other action as the 
petition warrants. Respondents are individuals or households, State or 
local governments, and not-for profit institutions or groups.
    Section 10.33 (21 CFR 10.33), issued under section 701(a) of the 
Federal, Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 
371(a)), sets forth the format and procedures by which an interested 
person may request reconsideration of part or all of a decision of the 
Commissioner on a petition submitted under 21 CFR 10.25 (Initiation of 
administrative proceedings). A petition for reconsideration must 
contain a full statement in a well-organized format of the factual and 
legal grounds upon which the petition relies. The grounds must 
demonstrate that relevant information and views contained in the 
administrative record were not previously or not adequately considered 
by the Commissioner. The respondent must submit a petition no later 
than 30 days after the decision involved. However, the Commissioner 
may, for good cause, permit a petition to be filed after 30 days. An 
interested person who wishes to rely on information or views not 
included in the administrative record shall submit them with a new 
petition to modify the decision. FDA uses the information provided in 
the request to determine whether to grant the petition for 
reconsideration. Respondents to this collection of information are 
individuals of households, State or local governments, not-for-profit 
institutions, and businesses or other for-profit institutions who are 
requesting from the Commissioner of FDA a reconsideration of a matter.
    Section 10.35 (21 CFR 10.35), issued under section 701(a) of the 
FD&C Act, sets forth the format and procedures by which an interested 
person may request, in accordance with Sec.  10.20 (Submission of 
documents to Division of Dockets Management), the Commissioner to stay 
the effective date of any administrative action.
    Such a petition must do the following: (1) Identify the decision 
involved; (2) state the action requested, including the length of time 
for which a stay is requested; and (3) include a statement of the 
factual and legal grounds on which the interested person relies in 
seeking the stay. FDA uses the information provided in the request to 
determine whether to grant the petition for stay of action.
    Respondents to this information collection are interested persons 
who choose to file a petition for an administrative stay of action.
    Section 10.85 (21 CFR 10.85), issued under section 701(a) of the 
FD&C Act, sets forth the format and procedures by which an interested 
person may request, in accordance with Sec.  10.20 (Submission of 
documents to Division of Dockets Management), an advisory opinion from 
the Commissioner on a matter of general applicability. An advisory 
opinion represents the formal position of FDA on a matter of general 
applicability. When making a request, the petitioner must provide a 
concise statement of the issues and questions on which an opinion is 
requested, and a full statement of the facts and legal points relevant 
to the request. Respondents to this collection of information are 
interested persons seeking an advisory opinion from the Commissioner on 
the Agency's formal position for matters of general applicability.
    FDA has developed a method for electronic submission of citizen 
petitions. The Agency still allows for non-electronic submissions; 
however, electronic submissions of a citizen petition to a specific 
electronic docket presents a simpler and more straightforward approach. 
FDA has created a single docket on https://www.regulations.gov, the U.S. 
Government's consolidated docket Web site for Federal Agencies, for the 
initial electronic submission of all citizen petitions. The advantage 
to this change is that it ensures efficiency and ease in communication, 
quicker interaction between citizen petitioners and FDA, and easier 
access to FDA to seek input through the citizen petition process.
    The regulations in 21 CFR 12.22, issued under section 701(e)(2) of 
the FD&C Act (21 U.S.C. 371(e)(2)), set forth the instructions for 
filing objections and requests for a hearing on a regulation or order 
under Sec.  12.20(d) (21 CFR 12.20(d)). Objections and requests must be 
submitted within the time specified in Sec.  12.20(e). Each objection, 
for which a hearing has been requested, must be separately numbered and 
specify the provision of the regulation or the proposed order. In 
addition, each objection must include a detailed description and 
analysis of the factual information and any other document, with some 
exceptions, supporting the objection. Failure to include this 
information constitutes a waiver of the right to a hearing on that 
objection. FDA uses the description and analysis to determine whether a 
hearing request is justified. The description and analysis may be used 
only for the purpose of determining whether a hearing has been 
justified under 21 CFR 12.24 and does not limit the evidence that may 
be presented if a hearing is granted.
    Respondents to this information collection are those parties that 
may be adversely affected by an order or regulation.
    Section 12.45 (21 CFR 12.45) issued under section 701 of the FD&C 
Act (21 U.S.C. 371), sets forth the format and procedures for any 
interested person to file a petition to participate in a formal 
evidentiary hearing, either personally or through a representative. 
Section 12.45 requires that any person filing a notice of participation 
state their specific interest in the proceedings, including the 
specific issues of fact about which the person desires to be heard. 
This section also requires that the notice include a statement that the 
person will present testimony at the hearing and will comply with 
specific requirements in 21 CFR 12.85, or, in the case of a hearing 
before a Public Board of Inquiry, concerning disclosure of data and 
information by participants (21 CFR 13.25). In accordance with Sec.  
12.45(e) the

[[Page 73322]]

presiding officer may omit a participant's appearance.
    The presiding officer and other participants will use the collected 
information in a hearing to identify specific interests to be 
presented. This preliminary information serves to expedite the 
prehearing conference and commits participation.
    The respondents are individuals or households, State or local 
governments, not-for-profit institutions and businesses, or other for-
profit groups and institutions.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
         21 CFR Section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
10.30_Citizen Petition..........             207               1             207              24           4,968
10.33_Administrative                           4               1               4              10              40
 reconsideration of action......
10.35_Administrative Stay of                   5               1               5              10              50
 Action.........................
10.85_Advisory Opinions.........               4               1               4              16              64
12.22_Filing Objections and                    3               1               3              20              60
 Requests for a Hearing on a
 Regulation or Order............
12.45_Notice of Participation...               4               1               4               3              12
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           5,194
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The burden estimates for this collection of information are based 
on Agency records and experience over the past 3 years.

    Dated: December 4, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-28825 Filed 12-9-14; 8:45 am]
BILLING CODE 4164-01-P
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