Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Fast Track Drug Development Programs: Designation, Development, and Application Review, 44780-44782 [2014-18168]

Download as PDF 44780 Federal Register / Vol. 79, No. 148 / Friday, August 1, 2014 / Notices study stimuli while they are still in the developmental stage. FDA will collect, analyze, and interpret information gathered through this generic clearance in order to: (1) Better understand characteristics of the target audience— its perceptions, knowledge, attitudes, beliefs, and behaviors—and use these in the development of appropriate survey/ research questions, study stimuli or communications; (2) more efficiently and effectively design survey/research questions and study stimuli; and (3) more efficiently and effectively design experimental studies. FDA is requesting approval of this new generic for collecting information through the use of qualitative methods (i.e., individual interviews, small group discussions and focus groups) for studies involving all tobacco products regulated by FDA. This information will be used as a first step to explore concepts of interest and assist in the development of quantitative study proposals, complementing other important research efforts in the Agency. This information may also be used to help identify and develop communication messages, which may be used in education campaigns. Focus groups play an important role in gathering information because they allow for an in-depth understanding of individuals’ attitudes, beliefs, motivations, and feelings. Focus group research serves the narrowly defined need for direct and informal public opinion on a specific topic. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Activity In Person Individual In-Depth Interviews ........................ General Public Focus Group Interviews ......................... Telephone Screening Interviews ..................................... Telephone Individual In-Depth Interviews ....................... 350 18,850 4,800 50 Total ......................................................................... Total annual responses Dated: July 29, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–18195 Filed 7–31–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0996] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Fast Track Drug Development Programs: Designation, Development, and Application Review Food and Drug Administration, HHS. ACTION: 350 18,850 4,800 50 Total hours 1 ......................... 1.5 ...................... .08 (5 minutes) ... 1 ......................... 350 28,275 384 50 ........................ 29,059 are no capital costs or operating and maintenance costs associated with this collection of information. The number of respondents to be included in each new pretest may vary, depending on the nature of the material or message being tested and the target audience. Table 1 provides examples of the types of studies that may be administered and estimated burden levels during the 3-year period. Time to read, view, or listen to the message being tested is built into the ‘‘Hours Per Response’’ figures. AGENCY: 1 1 1 1 Hours per response 24,050 1 There tkelley on DSK3SPTVN1PROD with NOTICES Number of responses per respondent Notice. The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain SUMMARY: VerDate Mar<15>2010 22:09 Jul 31, 2014 Jkt 232001 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 proposed collection of information concerning requests by sponsors of investigational new drugs and applicants for new drug or biologics licenses for fast track designation as provided in the Guidance for Industry on Fast Track Drug Development Programs: Designation, Development, and Application Review. DATES: Submit either electronic or written comments on the collection of information by September 30, 2014. ADDRESSES: Submit electronic comments on the collection of information to http:// 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 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. 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 SUPPLEMENTARY INFORMATION: E:\FR\FM\01AUN1.SGM 01AUN1 44781 Federal Register / Vol. 79, No. 148 / Friday, August 1, 2014 / Notices 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. Guidance for Industry: Fast Track Drug Development Programs: Designation, Development, and Application Review—(OMB Control Number 0910— 0389)—Extension Section 112(a) of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105–115) amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by adding section 506 (21 U.S.C. 356). The section authorizes FDA to take appropriate action to facilitate the development and expedite the review of new drugs, including biological products, intended to treat a serious or life-threatening condition and that demonstrate a potential to address an unmet medical need. Under section 112(b) of FDAMA, FDA issued guidance to industry on fast track policies and procedures outlined in section 506 of the FD&C Act. The guidance discusses collections of information that are specified under section 506 of the FD&C Act, other sections of the Public Health Service Act (the PHS Act), or implementing regulations. The guidance describes three general areas involving the collection of information: (1) Fast track designation requests, (2) premeeting packages, and (3) requests to submit portions of an application. Of these, fast track designation requests and premeeting packages, in support of receiving a fast track program benefit, provide for additional collections of information not covered elsewhere in statute or regulation. Information in support of fast track designation or fast track program benefits that has previously been submitted to the Agency, may, in some cases, be incorporated into the request by referring to the information rather than resubmitting it. Under section 506(a)(1) of the FD&C Act, an applicant who seeks fast track designation is required to submit a request to the Agency showing that the drug product: (1) Is intended for a serious or life-threatening condition and (2) has the potential to address an unmet medical need. Mostly, the Agency expects that information to support a designation request will have been gathered under existing provisions of the FD&C Act, the PHS Act, or the implementing regulations. If such information has already been submitted to the Agency, the information may be summarized in the fast track designation request. The guidance recommends that a designation request include, where applicable, additional information not specified elsewhere by statute or regulation. For example, additional information may be needed to show that a product has the potential to address an unmet medical need where an approved therapy exists for the serious or lifethreatening condition to be treated. Such information may include clinical data, published reports, summaries of data and reports, and a list of references. The amount of information and discussion in a designation request need not be voluminous, but it should be sufficient to permit a reviewer to assess whether the criteria for fast track designation have been met. After the Agency makes a fast track designation, a sponsor or applicant may submit a premeeting package that may include additional information supporting a request to participate in certain fast track programs. The premeeting package serves as background information for the meeting and should support the intended objectives of the meeting. As with the request for fast track designation, the Agency expects that most sponsors or applicants will have gathered such information to meet existing requirements under the FD&C Act, the PHS Act, or implementing regulations. These may include descriptions of clinical safety and efficacy trials not conducted under an investigational new drug application (i.e., foreign studies) and information to support a request for accelerated approval. If such information has already been submitted to FDA, the information may be summarized in the premeeting package. Consequently, FDA anticipates that the additional collection of information attributed solely to the guidance will be minimal. Under section 506(c) of the FD&C Act, a sponsor must submit sufficient clinical data for the Agency to determine, after preliminary evaluation, that a fast track product may be effective. Section 506(c) also requires that an applicant provide a schedule for the submission of information necessary to make the application complete before FDA can commence its review. The guidance does not provide for any new collection of information regarding the submission of portions of an application that are not required under section 506(c) of the FD&C Act or any other provision of the FD&C Act. All forms referred to in the guidance have current OMB approval: Forms FDA 1571 (OMB control number 0910–0014), 356h (OMB control number 0910–0338), and 3397 (OMB control number 0910– 0297). Respondents to this information collection are sponsors and applicants who seek fast track designation under section 506 of the FD&C Act. The Agency estimates the total annual number of respondents submitting requests for fast track designation to the Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research is approximately 81, and the number of requests received is approximately 115 annually. FDA estimates that the number of hours needed to prepare a request for fast track designation is approximately 60 hours per request. Not all requests for fast track designation may meet the statutory standard. Of the requests for fast track designation made per year, the Agency granted approximately 100 requests from 81 respondents, and for each of these granted requests a premeeting package was submitted to the Agency. FDA estimates that the preparation hours are approximately 100 hours per premeeting package. FDA estimates the burden of this collection of information as follows: tkelley on DSK3SPTVN1PROD with NOTICES TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Guidance for industry: Fast track drug development programs: Designation, development, and application review Number of respondents Designation Requests .......................................................... Premeeting Packages .......................................................... VerDate Mar<15>2010 22:09 Jul 31, 2014 Jkt 232001 PO 00000 Frm 00044 Number of responses per respondent 81 81 Fmt 4703 Sfmt 4703 Total annual responses 1.42 1.09 E:\FR\FM\01AUN1.SGM 115 88 01AUN1 Average burden per response 60 100 Total hours 6,900 8,800 44782 Federal Register / Vol. 79, No. 148 / Friday, August 1, 2014 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued Number of respondents Number of responses per respondent Total annual responses Average burden per response ........................ ........................ ........................ ........................ Guidance for industry: Fast track drug development programs: Designation, development, and application review Total .............................................................................. 1 There [FR Doc. 2014–18168 Filed 7–31–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–1048] Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Labeling Regulations 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 the information collection associated with the medical device labeling regulations. DATES: Submit either electronic or written comments on the collection of information by September 30, 2014. ADDRESSES: Submit electronic comments on the collection of information to http:// 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 SUMMARY: tkelley on DSK3SPTVN1PROD with NOTICES 15,700 are no capital costs or operating and maintenance costs associated with this collection of information. Dated: July 29, 2014. Leslie Kux, Assistant Commissioner for Policy. AGENCY: Total hours VerDate Mar<15>2010 22:09 Jul 31, 2014 Jkt 232001 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. 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. Medical Device Labeling Regulations— 21 CFR 800, 801, and 809 (OMB Control Number 0910–0485)—Extension Section 502 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 352), among other things, establishes requirements for the label or labeling of a medical device so that it is not misbranded and subject to a regulatory action. Certain provisions under section 502 require PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 manufacturers, importers, and distributors of medical devices to disclose information about themselves or the devices, on the labels or labeling for the devices. Section 502(b) of the FD&C Act requires that for packaged devices, the label must bear the name and place of business of the manufacturer, packer, or distributor as well as an accurate statement of the quantity of the contents. Section 502(f) of the FD&C Act requires that the labeling for a device must contain adequate directions for use. FDA may however, grant an exemption, if the Agency determines that the adequate directions for use labeling requirements are not necessary for the particular case, as it relates to protection of the public health. FDA regulations under parts 800, 801, and 809 (21 CFR parts 800, 801, and 809) require disclosure of specific information by manufacturers, importers, and distributors of medical devices about themselves or the devices, on the label or labeling for the devices to health professionals and consumers. FDA issued these regulations under the authority of sections 201, 301, 502, and 701 of the FD&C Act (21 U.S.C. 321, 331, 352, and 371). Most of the regulations under parts 800, 801, and 809 are derived from requirements of section 502 of the FD&C Act, which provides in part, that a device shall be misbranded if, among other things, its label or labeling fails to bear certain required information concerning the device, is false or misleading in any particular way, or fails to contain adequate directions for use. Recordkeeping Burden Section 801.150(a)(2) establishes recordkeeping requirements for manufacturers of devices to retain a copy of the agreement containing the specifications for the processing, labeling, or repacking of the device for 2 years after the shipment or delivery of the device. Section 801.150(a)(2) also requires that the subject respondents make copies of this agreement available for inspection at any reasonable hour to any officer or employee of the Department of Health and Human Services (HHS) who requests them. E:\FR\FM\01AUN1.SGM 01AUN1

Agencies

[Federal Register Volume 79, Number 148 (Friday, August 1, 2014)]
[Notices]
[Pages 44780-44782]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-18168]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0996]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Guidance for Industry: Fast Track Drug Development 
Programs: Designation, Development, and Application Review

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 proposed collection of 
information concerning requests by sponsors of investigational new 
drugs and applicants for new drug or biologics licenses for fast track 
designation as provided in the Guidance for Industry on Fast Track Drug 
Development Programs: Designation, Development, and Application Review.

DATES: Submit either electronic or written comments on the collection 
of information by September 30, 2014.

ADDRESSES: Submit electronic comments on the collection of information 
to http://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.
    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

[[Page 44781]]

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.

Guidance for Industry: Fast Track Drug Development Programs: 
Designation, Development, and Application Review--(OMB Control Number 
0910--0389)--Extension

    Section 112(a) of the Food and Drug Administration Modernization 
Act of 1997 (FDAMA) (Pub. L. 105-115) amended the Federal Food, Drug, 
and Cosmetic Act (the FD&C Act) by adding section 506 (21 U.S.C. 356). 
The section authorizes FDA to take appropriate action to facilitate the 
development and expedite the review of new drugs, including biological 
products, intended to treat a serious or life-threatening condition and 
that demonstrate a potential to address an unmet medical need. Under 
section 112(b) of FDAMA, FDA issued guidance to industry on fast track 
policies and procedures outlined in section 506 of the FD&C Act. The 
guidance discusses collections of information that are specified under 
section 506 of the FD&C Act, other sections of the Public Health 
Service Act (the PHS Act), or implementing regulations. The guidance 
describes three general areas involving the collection of information: 
(1) Fast track designation requests, (2) premeeting packages, and (3) 
requests to submit portions of an application. Of these, fast track 
designation requests and premeeting packages, in support of receiving a 
fast track program benefit, provide for additional collections of 
information not covered elsewhere in statute or regulation. Information 
in support of fast track designation or fast track program benefits 
that has previously been submitted to the Agency, may, in some cases, 
be incorporated into the request by referring to the information rather 
than resubmitting it.
    Under section 506(a)(1) of the FD&C Act, an applicant who seeks 
fast track designation is required to submit a request to the Agency 
showing that the drug product: (1) Is intended for a serious or life-
threatening condition and (2) has the potential to address an unmet 
medical need. Mostly, the Agency expects that information to support a 
designation request will have been gathered under existing provisions 
of the FD&C Act, the PHS Act, or the implementing regulations. If such 
information has already been submitted to the Agency, the information 
may be summarized in the fast track designation request. The guidance 
recommends that a designation request include, where applicable, 
additional information not specified elsewhere by statute or 
regulation. For example, additional information may be needed to show 
that a product has the potential to address an unmet medical need where 
an approved therapy exists for the serious or life-threatening 
condition to be treated. Such information may include clinical data, 
published reports, summaries of data and reports, and a list of 
references. The amount of information and discussion in a designation 
request need not be voluminous, but it should be sufficient to permit a 
reviewer to assess whether the criteria for fast track designation have 
been met.
    After the Agency makes a fast track designation, a sponsor or 
applicant may submit a premeeting package that may include additional 
information supporting a request to participate in certain fast track 
programs. The premeeting package serves as background information for 
the meeting and should support the intended objectives of the meeting. 
As with the request for fast track designation, the Agency expects that 
most sponsors or applicants will have gathered such information to meet 
existing requirements under the FD&C Act, the PHS Act, or implementing 
regulations. These may include descriptions of clinical safety and 
efficacy trials not conducted under an investigational new drug 
application (i.e., foreign studies) and information to support a 
request for accelerated approval. If such information has already been 
submitted to FDA, the information may be summarized in the premeeting 
package. Consequently, FDA anticipates that the additional collection 
of information attributed solely to the guidance will be minimal.
    Under section 506(c) of the FD&C Act, a sponsor must submit 
sufficient clinical data for the Agency to determine, after preliminary 
evaluation, that a fast track product may be effective. Section 506(c) 
also requires that an applicant provide a schedule for the submission 
of information necessary to make the application complete before FDA 
can commence its review. The guidance does not provide for any new 
collection of information regarding the submission of portions of an 
application that are not required under section 506(c) of the FD&C Act 
or any other provision of the FD&C Act.
    All forms referred to in the guidance have current OMB approval: 
Forms FDA 1571 (OMB control number 0910-0014), 356h (OMB control number 
0910-0338), and 3397 (OMB control number 0910-0297).
    Respondents to this information collection are sponsors and 
applicants who seek fast track designation under section 506 of the 
FD&C Act. The Agency estimates the total annual number of respondents 
submitting requests for fast track designation to the Center for 
Biologics Evaluation and Research and the Center for Drug Evaluation 
and Research is approximately 81, and the number of requests received 
is approximately 115 annually. FDA estimates that the number of hours 
needed to prepare a request for fast track designation is approximately 
60 hours per request.
    Not all requests for fast track designation may meet the statutory 
standard. Of the requests for fast track designation made per year, the 
Agency granted approximately 100 requests from 81 respondents, and for 
each of these granted requests a premeeting package was submitted to 
the Agency. FDA estimates that the preparation hours are approximately 
100 hours per premeeting package.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
   Guidance for industry: Fast
track drug development programs:     Number of       Number of     Total annual       Average
  Designation, development, and     respondents   responses  per     responses      burden per      Total hours
       application review                            respondent                      response
----------------------------------------------------------------------------------------------------------------
Designation Requests............              81            1.42             115              60           6,900
Premeeting Packages.............              81            1.09              88             100           8,800
���������������������������������

[[Page 44782]]

 
    Total.......................  ..............  ..............  ..............  ..............          15,700
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: July 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-18168 Filed 7-31-14; 8:45 am]
BILLING CODE 4164-01-P