82 FR 27841 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Pharmacogenomic Data Submission
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 116 (June 19, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 116 (June 19, 2017)
| Page Range | 27841-27842 | |
| FR Document | 2017-12604 |
[Federal Register Volume 82, Number 116 (Monday, June 19, 2017)] [Notices] [Pages 27841-27842] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-12604] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0536] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Pharmacogenomic Data Submission AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by July 19, 2017. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to [email protected]. All comments should be identified with the OMB control number 0910-0557. Also include the FDA docket number found in brackets in the heading of this document. [[Page 27842]] FOR FURTHER INFORMATION CONTACT: Jonnalynn Capezutto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, [email protected]. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Guidance for Industry on Pharmacogenomic Data Submissions; OMB Control Number 0910-0557--Extension The collection of information supports Agency guidance entitled, ``Guidance for Industry on Pharmacogenomic Data Submissions.'' The guidance provides recommendations to sponsors submitting or holding investigational new drug applications (INDs), new drug applications (NDAs), or biologics license applications (BLAs) on what pharmacogenomic data should be submitted to the Agency during the drug development process. Sponsors holding, and applicants submitting, INDs, NDAs, or BLAs are subject to FDA requirements for submitting to the Agency data relevant to drug safety and efficacy (21 CFR 312.22, 312.23, 312.31, 312.33, 314.50, 314.81, 601.2, and 601.12). The guidance interprets FDA regulations for IND, NDA, or BLA submissions, clarifying when the regulations require pharmacogenomics data to be submitted and when the submission of such data is voluntary. The pharmacogenomic data submissions described in the guidance that are required to be submitted to an IND, NDA, BLA, or annual report are covered by the information collection requirements under 21 CFR parts 312, 314, and 601 (approved under OMB control numbers 0910-0014 (part 312, INDs); 0910-0001 (part 314, NDAs and annual reports); and 0910- 0338 (part 601, BLAs)), respectively. The guidance distinguishes between pharmacogenomic tests that may be considered valid biomarkers appropriate for regulatory decisionmaking, and other, less well-developed exploratory tests. The submission of exploratory pharmacogenomic data is not required under the regulations, although the Agency encourages the voluntary submission of such data. The guidance describes the voluntary genomic data submission (VGDS) that can be used for such a voluntary submission. The guidance does not recommend a specific format for the VGDS, except that such a voluntary submission be designated as a VGDS. The data submitted in a VGDS and the level of detail should be sufficient for FDA to be able to interpret the information and independently analyze the data, verify results, and explore possible genotype-phenotype correlations across studies. FDA does not want the VGDS to be overly burdensome and time- consuming for the sponsor. In the Federal Register of March 17, 2017 (82 FR 14221), we published a 60-day notice requesting public comment on the proposed extension of this collection of information. One comment was received, however it was not responsive to the four information collection topics solicited in the notice and therefore is not addressed here. FDA has estimated the burden of preparing a voluntary submission described in the guidance that should be designated as a VGDS based on our experience with these submissions over the past few years, and on our familiarity with sponsors' interest in submitting pharmacogenomic data during the drug development process. In 2013, we received three VGDS. Since 2013, there have been no submission of VGDS; however, for purposes of this information collection approval, we are estimating that we may receive one submission annually. We estimate each submission requires approximately 50 hours to prepare and submit to FDA. We therefore estimate the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Information collection activity Number of responses per Total annual Hours per Total hours respondents respondent responses response -------------------------------------------------------------------------------------------------------------------------------------------------------- Voluntary Genomic Data Submissions................................. 1 1 1 50 50 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection. Dated: June 13, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-12604 Filed 6-16-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 116 / Monday, June 19, 2017 / Notices 27841
electronic and written/paper comments requirement, FDA is publishing notice methods to be used serve the narrowly
received, go to https:// of the proposed collection of defined need for direct and informal
www.regulations.gov and insert the information set forth in this document. opinion on a specific topic and have
docket number, found in brackets in the With respect to the following two major purposes: To obtain
heading of this document, into the collection of information, FDA invites information that is useful in formulating
‘‘Search’’ box and follow the prompts comments on these topics: (1) Whether policies and regulatory decisions and
and/or go to the Dockets Management the proposed collection of information for developing variables and measures
Staff, 5630 Fishers Lane, Rm. 1061, is necessary for the proper performance for formulating the basic objectives of
Rockville, MD 20852. of FDA’s functions, including whether risk communication campaigns, and to
FOR FURTHER INFORMATION CONTACT: the information will have practical assess the potential effectiveness of
Domini Bean, Office of Operations, utility; (2) the accuracy of FDA’s messages and materials in reaching and
Food and Drug Administration, Three estimate of the burden of the proposed successfully communicating with their
White Flint North, 10A63, 11601 collection of information, including the intended audiences.
Landsdown St., North Bethesda, MD validity of the methodology and
FDA will use these methods to test
20852, 301–796–5733, PRAStaff@ assumptions used; (3) ways to enhance
and help refine messages and other
fda.hhs.gov. the quality, utility, and clarity of the
communications but will generally
information to be collected; and (4)
SUPPLEMENTARY INFORMATION: Under the conduct further research before making
ways to minimize the burden of the
PRA (44 U.S.C. 3501–3520), Federal important decisions. FDA will use this
collection of information on
Agencies must obtain approval from the mechanism to test messages about
respondents, including through the use
Office of Management and Budget regulated drug products on a variety of
of automated collection techniques,
(OMB) for each collection of subjects related to consumer, patient, or
when appropriate, and other forms of
information they conduct or sponsor. health care professional perceptions and
information technology.
‘‘Collection of information’’ is defined about use of drug products and related
in 44 U.S.C. 3502(3) and 5 CFR Data To Support Drug Product materials, including but not limited to,
1320.3(c) and includes Agency requests Communications as Used by the Food direct-to-consumer prescription drug
or requirements that members of the and Drug Administration; OMB Control promotion, physician labeling of
public submit reports, keep records, or Number 0910–0695—Extension prescription drugs, medication guides,
provide information to a third party. Testing of messages in advance of a over-the-counter drug labeling,
Section 3506(c)(2)(A) of the PRA (44 communication campaign provides an emerging risk communications, patient
U.S.C. 3506(c)(2)(A)) requires Federal important role in improving FDA labeling, online sale of medical
Agencies to provide a 60-day notice in communications. The methods to be products, and consumer and
the Federal Register concerning each employed include individual indepth professional education. Annually, FDA
proposed collection of information, interviews, general public focus group projects about 45 communication
including each proposed extension of an interviews, intercept interviews, self- studies using the variety of test methods
existing collection of information, administered surveys, gatekeeper listed in this document.
before submitting the collection to OMB surveys, and professional clinician FDA estimates the burden of this
for approval. To comply with this focus group interviews. The qualitative collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average burden
Number of Total annual
responses per per response Total hours
respondents responses
respondent (in hours)
Interviews/Surveys .................................................... 19,822 1 19,822 0.24 (14 minutes) ..... 4,757
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 13, 2017. DEPARTMENT OF HEALTH AND Office of Management and Budget
Anna K. Abram, HUMAN SERVICES (OMB) for review and clearance under
Deputy Commissioner for Policy, Planning, the Paperwork Reduction Act of 1995.
Legislation, and Analysis. Food and Drug Administration
DATES: Fax written comments on the
[FR Doc. 2017–12601 Filed 6–16–17; 8:45 am] [Docket No. FDA–2010–N–0536] collection of information by July 19,
BILLING CODE 4164–01–P 2017.
Agency Information Collection
Activities; Submission for Office of ADDRESSES: To ensure that comments on
Management and Budget Review; the information collection are received,
Comment Request; Guidance for OMB recommends that written
Industry on Pharmacogenomic Data comments be faxed to the Office of
Submission Information and Regulatory Affairs,
asabaliauskas on DSKBBXCHB2PROD with NOTICES
AGENCY: Food and Drug Administration, OMB, Attn: FDA Desk Officer, FAX:
HHS. 202–395–7285, or emailed to oira_
ACTION: Notice. submission@omb.eop.gov. All
comments should be identified with the
SUMMARY: The Food and Drug OMB control number 0910–0557. Also
Administration (FDA) is announcing include the FDA docket number found
that a proposed collection of in brackets in the heading of this
information has been submitted to the document.
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![27842 Federal Register / Vol. 82, No. 116 / Monday, June 19, 2017 / Notices
FOR FURTHER INFORMATION CONTACT: The guidance interprets FDA information and independently analyze
Jonnalynn Capezutto, Office of regulations for IND, NDA, or BLA the data, verify results, and explore
Operations, Food and Drug submissions, clarifying when the possible genotype-phenotype
Administration, Three White Flint regulations require pharmacogenomics correlations across studies. FDA does
North, 10A63, 11601 Landsdown St., data to be submitted and when the not want the VGDS to be overly
North Bethesda, MD 20852, 301–796– submission of such data is voluntary. burdensome and time-consuming for the
3794, PRAStaff@fda.hhs.gov. The pharmacogenomic data submissions sponsor.
SUPPLEMENTARY INFORMATION: In described in the guidance that are
In the Federal Register of March 17,
compliance with 44 U.S.C. 3507, FDA required to be submitted to an IND,
NDA, BLA, or annual report are covered 2017 (82 FR 14221), we published a 60-
has submitted the following proposed
by the information collection day notice requesting public comment
collection of information to OMB for
requirements under 21 CFR parts 312, on the proposed extension of this
review and clearance.
314, and 601 (approved under OMB collection of information. One comment
Guidance for Industry on control numbers 0910–0014 (part 312, was received, however it was not
Pharmacogenomic Data Submissions; INDs); 0910–0001 (part 314, NDAs and responsive to the four information
OMB Control Number 0910–0557— annual reports); and 0910–0338 (part collection topics solicited in the notice
Extension 601, BLAs)), respectively. and therefore is not addressed here.
The collection of information The guidance distinguishes between FDA has estimated the burden of
supports Agency guidance entitled, pharmacogenomic tests that may be preparing a voluntary submission
‘‘Guidance for Industry on considered valid biomarkers appropriate described in the guidance that should be
Pharmacogenomic Data Submissions.’’ for regulatory decisionmaking, and designated as a VGDS based on our
The guidance provides other, less well-developed exploratory experience with these submissions over
recommendations to sponsors tests. The submission of exploratory the past few years, and on our
submitting or holding investigational pharmacogenomic data is not required familiarity with sponsors’ interest in
new drug applications (INDs), new drug under the regulations, although the submitting pharmacogenomic data
applications (NDAs), or biologics Agency encourages the voluntary during the drug development process. In
license applications (BLAs) on what submission of such data. 2013, we received three VGDS. Since
pharmacogenomic data should be The guidance describes the voluntary
2013, there have been no submission of
submitted to the Agency during the drug genomic data submission (VGDS) that
can be used for such a voluntary VGDS; however, for purposes of this
development process. Sponsors holding,
submission. The guidance does not information collection approval, we are
and applicants submitting, INDs, NDAs,
recommend a specific format for the estimating that we may receive one
or BLAs are subject to FDA
requirements for submitting to the VGDS, except that such a voluntary submission annually. We estimate each
Agency data relevant to drug safety and submission be designated as a VGDS. submission requires approximately 50
efficacy (21 CFR 312.22, 312.23, 312.31, The data submitted in a VGDS and the hours to prepare and submit to FDA.
312.33, 314.50, 314.81, 601.2, and level of detail should be sufficient for We therefore estimate the burden of
601.12). FDA to be able to interpret the this collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Hours per
Information collection activity responses per Total hours
respondents responses response
respondent
Voluntary Genomic Data Submissions ................................ 1 1 1 50 50
1 There are no capital costs or operating and maintenance costs associated with this collection.
Dated: June 13, 2017. DEPARTMENT OF HEALTH AND Paperwork Reduction Act of 1995
Anna K. Abram, HUMAN SERVICES (PRA), Federal Agencies are required to
Deputy Commissioner for Policy, Planning, publish notice in the Federal Register
Legislation, and Analysis. Food and Drug Administration concerning each proposed collection of
[FR Doc. 2017–12604 Filed 6–16–17; 8:45 am] [Docket No. FDA–2017–N–1315] information and to allow 60 days for
public comment in response to the
BILLING CODE 4164–01–P
Agency Information Collection notice. This notice solicits comments on
Activities; Proposed Collection; research entitled ‘‘Experimental Study
Comment Request; Experimental of Risk Information Amount and
Study of Risk Information Amount and Location in Direct-to-Consumer Print
Location in Direct-to-Consumer Print Ads.’’ This study will examine how
Ads repetition and overwarning apply to the
presentation of risks in the context of
asabaliauskas on DSKBBXCHB2PROD with NOTICES
AGENCY: Food and Drug Administration, direct-to-consumer print advertising.
HHS.
DATES: Submit either electronic or
ACTION: Notice. written comments on the collection of
SUMMARY: The Food and Drug information by August 18, 2017.
Administration (FDA) is announcing an ADDRESSES: You may submit comments
opportunity for public comment on the as follows. Please note that late,
proposed collection of certain untimely filed comments will not be
information by the Agency. Under the considered. Electronic comments must
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Document Created: 2017-06-17 01:47:52
Document Modified: 2017-06-17 01:47:52
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by July 19, 2017. | |
| Contact | Jonnalynn Capezutto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, [email protected] | |
| FR Citation | 82 FR 27841 |
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